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Pharma Times - Vol. 54 - No. 11, November 2022 3
Contents
Bioelectronic Medicine: A New Vista For Chronic Diseases
S. S. Manikiran1, Lakshmi Prasanthi Nori2,
1 Professor, Department of Pharmacognosy, Vignan Pharmacy College, Vadlamudi.
2 Professor, Department of Pharmaceutical Quality Assurance, Shri Vishnu College of Pharmacy, Bhimavaram ...............................7
Introduction to Nutraceuticals And Its Regulatory Requirements In India
Swathi J. B. Pharm, Dr. D. Nagasamy Venkatesh PhD,
Regulatory Affairs, Department of Pharmaceutics,
JSS College of Pharmacy, Ootacamund, The Nilgiris, Tamil Nadu.
(Affiliated to JSS Academy of Higher Education and Research)......................................................................................................14
A Review on Chronotherapy & the Role of Chronotherapeutic Drugs
G J Vaishnavee1, Aasiya Nahas2, Dr Deepu S3
M.Pharm, Department of Pharmaceutics, Mar Dioscorus College of Pharmacy,
Alathara, Sreekaryam, Thiruvananthapuram, Kerala .....................................................................................................................18
Tropical Disease Priority Review Vouchers- A Review
Sanika Sangle, Dr. Muddukrishna B.S, Bhavin Modi, Dr. S G Vasantharaju*
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences MAHE, Manipal, Karnataka, India .........24

Pharma Times
Regular Features Official Publication of
The Indian Pharmaceutical Association
President Speak.................................................................. 5 Indexed by Scopus & Embase

Announcements............................................................. 6,29 Editor Sayalee Ghume Hemanta Kr. Sharma

Dr. Alka Mukne Advisory Board Dr. Jayant Dave
Book Review.................................................................... 29 Editorial Dr. A. I. Mehta Kalhan Bazaz
Assistants Dr. B. Suresh M.P. George
Pharma Wits And Leisure.................................................. 30 Saee H. Misal Dr. C. Gopalakrishna
Dr. N. Shivaprasad
Sakshi Y. Kasat Dr. P. Khadgapathi
Murty
Association News............................................................. 31 Vinay Kadam Dr. J. A. S. Giri
Dr. Premnath Shenoy
Mitali Thorat Puneet Gupta
Kaushik Desai
Advertisement Index......................................................... 32 Lay Pasad Dr. P.N. Murthy
Dr. Mukund Yelvigi
Bhagyashree Garud Raj Vaidya
Prafull Sheth
Rajesh Bhandari
World Pharmacists Day..................................................... 33 Divya Jaiswal Dr. Rao V.S.V.
Shivani Tiwari Dr. R.N. Gupta
Vadlamudi Sanjay Jain
Pharmascence.................................................................. 37 Aryan Puranik
Shashikant Joag
Shivam Vij Dr. Shailendra Saraf
Subodh Priolkar Shyamal Kalani
Campus News .................................................................. 41 Ankit Roy
Sripati Singh
Anuprita Pawar Editorial Board
Sakshi Vispute Dr B.N. Sinha Dr. Subhash Mandal
Printed by Dr. Alka Mukne, Published by Dr. Alka Mukne on behalf of The Indian Srushti Deshmukh Dr. Divakar Goli Dr. S.P. Manek
Pharmaceutical Association and published at The Indian Pharmaceutical Association, Prof. T.V. Narayana
Aditi Singh Dr. G. Sumalatha
Kalina, Santacruz (E), Mumbai 400 098.
For Pharma Times Advertisements please contact
Copyright of Indian Pharmaceutical Association.
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Tel.: 2446 2632 / 3872 Fax: 2444 9765. E-mail: [email protected] Tel: 91-22-2667 1072 E-mail: [email protected]

Pharma Times - Vol. 54 - No. 11, November 2022 4

President Speak...
After a gap of two years, the 28th Federation chosen to highlight the prominent role played
of Asian Pharmaceutical Associations (FAPA) by the Indian pharma industry in the global
Congress was held in Kuala Lumpur, Malaysia arena. We should feel proud of contribution
at the Kuala Lumpur City Centre (KLCC) of Indian pharma industry as largest provider
Convention Center during 8-12, November of generic medicines globally, occupying
2022 with the theme, “Pharmacists Building a 20%  share in global supply by volume
Better Health Systems”. The Malaysian and is the leading vaccine manufacturer
Pharmacists Society (MPS) being the host globally with more than 3,000 pharma
have prepared a stimulating program and companies with a strong network of over
inspired pharmacists from all over Asia. More 10,500 manufacturing facilities as well as a
than 2000 participants from 24 countries highly skilled resource pool . Though we are
attended the 28th FAPA Congress. called the Pharmacy of the World and nearly
Mrs.Yolanda Robles, FAPA President in her one million registered Pharmacists serving
Presidential address thanked all the Member Community Pharmacy in India, the present
Associations and their officers as well as the system requires proper mechanisms or
FAPA Bureau, Malaysian Pharmaceutical regulations to update the Pharmacists in the
Society, Section Chairpersons, Committee Pharmacy practice area. Our community and
Chairpersons and the Secretariat for hospital pharmacists have to upgrade their
welcoming her as your new President. She knowledge with expertise in clinical set up
The theme "Pharmacy of the expressed that FAPA has to play an important and advise patients and build a brand image
role to take on the noble mission of the of “most trusted and accessible health care
World : India” was chosen to organization for the pharmacists in this vast professional” on par with global standards. I
Region. She expressed that as pharmacists in wish all the IPA members will take initiative
highlight the prominent role our respective countries, our contribution to in this direction and organize training and
the health system is well-defined and we need skill development programmes so as to see
played by the Indian pharma to make sure that our people have access to that our community pharmacists in future will
quality medicines and services necessary work with other health care professionals to
industry in the global arena. for them to maintain health, and reduce ensure that every individual receives optimal
illness and death. We need to be pro-active treatment.
We should feel proud of in health policy-making, advocacies, and
programs that will improve how medicines are I am happy to share that a good number
contribution of Indian pharma of delegates from India representing IPA
managed in our countries. We need to work
and collaborate with various organizations attended the 28th FAPA congress at Kuala
industry as largest provider of Lumpur, Malaysia. I am of the opinion that
which are pursuing similar missions at the
global and regional levels. We need to align IPA got good recognition for the collaborative
generic medicines globally. activities done in the last two years and given
with the United Nations’ (UN) Sustainable
Development Goals to help address issues prominence during the congress. Our IPA
It is a great moment in my life to receive concerning the health of the populations. members were involved in various sessions
the FAPA - Ishidate award in Pharmacy Similarly, within the pharmacy profession, the like Deans Forum, moderator, evaluator. As we
Education category during the opening International Pharmaceutical Federation (FIP) all know IPA has announced Fellowship 2021
ceremony of the 28th FAPA Congress 10th came up with its Development Goals which to Mrs.Yolanda Robles, President of FAPA for
November 2022. Winners of other categories aim to transform the profession and maximize her constant support to IPA in developing the
are Dr. Soo-Ja Nam of South Korea (Life the contribution of pharmacists to health profession of pharmacy and other activities in
Time Achievement), Chin-Shun Huang care around the globe. Finally, she appealed uplifting the profession of pharmacy in India.
of Taiwan (Community Pharmacy), Hazel to member organizations to solicit their Yolanda was honoured with its IPA Fellowship
Faye Ricaforte Docuyanen of Philippines support and cooperation for the programs Award on 11th November 2022 by the IPA
(Hospital Pharmacy), Dr Mohammad Abdur and activities that FAPA will plan in future in team. Mrs.Yolanda Robles, President of FAPA
Rashid of Bangladesh (Pharmaceutical support of the new vision and mission and thanked IPA for the great honour and said “I
Research) and Dr Noppadon Adjimateria of move forward our profession. am pleased and honoured to receive the IPA
Thailand (Pharmaceutical Industry). The FAPA fellowship. She thanked IPA for the excellent
President, Dr Yolanda Robles honoured the The flagship activity of IPA, 61st ‘National support in organising various collaborative
awardees. It gives me immense pleasure that Pharmacy Week’ (NPW- 2022) was celebrated activities and expressed her happiness to
the services rendered to IPA, especially to in grand manner throughout the country know Pharmacist achievements in India.
pharmacy education, have been recognized during 20-26, November 2022. I thank all
internationally and instrumental for this rare the Principals and Students of Pharmacy
honour and gives more encouragement and colleges, all IPA State and Local branches
enthusiasm to work further and strengthen and every individual for their contribution and
collaborative activities with countries of Asian for making NPW-2022 a grand success. The
region”. theme "Pharmacy of the World : India" was Dr. T. V. Narayana

Pharma Times - Vol. 54 - No. 11, November 2022 5

 IPA BUILDING SPONSORSHIP OPPORTUNITIES

Pharma Times - Vol. 52 - No. 05 - May 2020 34

Pharma Times - Vol. 54 - No. 11, November 2022 6 Pharma Times - Vol. 54 - No. 04-05, April-May 2022 5
Article Article

BIOELECTRONIC MEDICINE: A NEW VISTA FOR CHRONIC DIS-

EASES
S. S. Manikiran[1], Lakshmi Prasanthi Nori [2],
[1]
Professor, Department of Pharmacognosy, Vignan Pharmacy College, Vadlamudi.
[2] Professor, Department of Pharmaceutical Quality Assurance, Shri Vishnu College of Pharmacy, Bhimavaram.

ABSTRACT:
Bioelectronics is a recent interdisciplinary area exploring the impact of the electric field on the cell membrane and other elements of
the cell. It is a combination of neuroelectronics and bio-sensing. The new field of bioelectronic medicine has been created to influence
neural manipulation, having the ability to influence organ function. Electrical inputs or signals of the nervous system give rise to the
potential to expand the use of bioelectronic medicine for the treatment of diseases. Most peripheral organs are internalized by the
nervous system and provide fine tuning to regulate the immune system. Most of the research centered on stimulating the vagus nerve
and molecular pathways for regulating the immune system. In this study, we concentrated on the methods used for development of
bioelectronic medicine, their global market value, applications and FDA approved bioelectronic medicines.
Keywords: Bioelectronics, nervous system, vagus nerve, medicine, immune system.

INTRODUCTION: epilepsy/Parkinson’s disease - deep brain stimulation. These are

effective, but show unwanted side effects due to release of an
Since time immemorial, people have used drugs to treat electrical pulse to relatively large areas or groups of nerve fibers.
diseases mainly for pain. Prior to 3000 BC, Morphine was used For treating Refractory Epilepsy, in 1997 USFDA approved a pulse
to relieve pain from the source of the opium poppy plant’s juice. generator, which induces vagal stimulation after implantation near
Aspirin, the 1899 breakthrough drug is a synthesized version of a the clavicle. In 2005, FDA approved a similar stimulation procedure
fever remedy using the white willow bark extracts. Over the course for drug-resistant depression [8-10]. The first bioelectronic device as
of the 20th century, medicines became the basis of health care depicted in Figure 2.
[1, 2]
. If someone is sick or disabled, they should take a drug or a
medical device. The medications are highly effective but do not The central nervous system controls the working of each
show similar effects on all patients. They enter the bloodstream organ in the body. It is due to the electric impulses running along
and affect the whole body and exhibit unexpected or sometimes the nerve fibers. All organs are connected to CNS by peripheral
harmful side effects. At present, there are a number of chronic nerves. The normal nervous system is responsible for applying
diseases which are poorly treated or untreated by medicines. logic for processing and responding to provocation in the CNS. In
To resolve this, scientists are talking about experimental and the brain itself, hundreds of discrete neurons exist, characterized
non-pharmaceutical treatments such as immunotherapy, which by their form, length, myelination and release. The transistor of
re-engineers T cells, harnessing our immune system’s power to intensified electrical signals can lead signal conduction along the
fight disease viz., leukemia [3]. The MIT laboratory of Daniela Rus neuron’s length. Biologically, the signals of neurons are controlled
concentrated on ingestible robotic medicine, i.e. swallowing a tiny by neurotransmitters. The signal pathway is affected by their
bot that could be handled internally [4]. In the nervous system, the concentration, time and stimulation. Neurons can be grouped
presence of electrical communication was observed in the late 18thth into two major types in the Peripheral Nervous System (PNS) i.e.
century. Luigi Galvani, the forefather of Electrophysiology explained sensory and motor. Sensory or afferent fibers transmit data from
the relation between nervous system, muscle contractions and the periphery to CNS, motor or efferent fibers from the CNS to the
electricity e.g., muscle contraction due to application of electricity periphery. In PNS, the neuron’s axon can stretch over a meter i.e.
on the sciatic nerve [5][5]. from the spinal cord to toes. By the wave of depolarization, the
signals are transmitted through the voltage-gated ion channels
Bioelectronics is an emerging collaborative work, uniting along the axon. Neuron-mediated electrical communication is
knowledge of physics, material sciences, modeling, electrical the universal fast electrical communication system of the body
concepts, simulations, molecular biology, animal sciences and which orchestrates macro-level organ function. The passage of
medicine. Bioelectronic medicines thus joined in the scenario of the charges across the membrane adds potential for action, which
modern therapy class that was invented in the mid-1990s, nerve is a significant electrical interaction channel in muscle cells,
fibers receiving the electrical impulses. This is often referred to as neurons and endocrine cells. In addition to other communication
Electroceutical/Neuromodulation, which transforms the medical routes, all cells use faradaic current to communicate and are vital
treatment of many dreadful diseases and provides an alternative to maintain homeostasis [11-13][11-13]. Faradaic current is developed by
or supplement to traditional chemical/ biological medicines. The biochemical processes in the redox reactions, which is due to the
functional
functional assemblies
assemblies of of Bioelectronics
Bioelectronics were
were depicted
depicted inin Figure
Figure 1.
1. movement
movement of of electrons
electrons i.e.
i.e. electron
electron donor
donor toto electron
electron acceptor,
acceptor, the
the
This
This innovative
innovative approach
approach for
for disease
disease care
care has
has begun
begun to to become
become process
process isis shown
shown inin Figure
Figure 3. 3. Faradaic
Faradaic currents
currents hingehinge on
on NADH,
NADH,
a
a reality
reality with
with technical
technical progress
progress and
and increasing
increasing scientific
scientific activity.
activity. NADPH,
NADPH, GSH,
GSH, ascorbic
ascorbic acid
acid and
and ubiquinone
ubiquinone whichwhich are
are biological
biological
Peder
Peder Olofsson,
Olofsson, a a senior
senior scientist,
scientist, hypothesized
hypothesized that
that by
by observing
observing electrochemical
electrochemical mediators.
mediators. The The pattern
pattern of of electrical
electrical impulses
impulses
the
the mechanism
mechanism of of electronics
electronics in
in the
the nervous
nervous system
system and
and tissues,
tissues, varies
varies in
in chronic
chronic disease
disease and
and organ
organ malfunction
malfunction e.g. e.g. kidney,
kidney, liver
liver
it
it is
is possible
possible to to improve
improve the
the diagnosis
diagnosis andand treatment
treatment of of awful
awful problems.
problems. TheThe aim
aim of
of bioelectronic
bioelectronic medicine
medicine is is to
to restore
restore the
the
diseases
diseases [6, 7].. For
[6, 7]
For decades,
decades, electrically
electrically stimulating
stimulating body
body parts
parts ‘normal’
‘normal’ pattern
pattern by
by implanting
implanting tiny tiny devices
devices thatthat can
can be
be detected
detected
have
have been
been used
used to to alleviate
alleviate disease
disease viz.,
viz., heartbeat-pacemakers,
heartbeat-pacemakers, and
and selectively
selectively modulated
modulated (by(by stimulating
stimulating or or blocking)
blocking) onon individual
individual
hearing-cochlear
hearing-cochlear implants,
implants, pain
pain treatment-spinal
treatment-spinal cord
cord stimulators,
stimulators, nerves
nerves oror different
different bundles
bundles of of axons
axons [14, 15].. Cells
[14, 15]
Cells which
which can
can not
not

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12 Pharma Times - Vol. 54 - No. 11, November 2022 7
 Article

transmit potential for action i.e. non-excitable cells, also exhibit technology provides data related to bioelectronics media
endogenous electric fields and electrical properties for growth/ mapping and neural signal mapping. The old method of
healing. The cellular function can be controlled by computing these electrode based interface needs to be updated and miniaturized
cells with electronic devices. The electrical current regulates the to test visceral nerves effectively i.e. < 100 μm nerve diameter
polarization of the membrane potential, this can be coordinated and and with new materials.
stimulated. This transmembrane potential controls the movement ● Miniaturize interfaces with small organs and adjacent
of ions and molecules through it, for example by regulating Ca2+ nerves to enable rodent disease models to function.
and the channels of the Epidermal Growth Factor (EGFR). The ● Adjust interface materials and designs to suit visceral
effects of impaired ion and molecular transmission are observed neuroanatomy’s specific needs.
in some diseases viz., cancer, pulmonary oedema and the
● Interfaces for tailor electrodes to assess the patterns of
possibility of transportation regulation across the cell membrane
electrical impulses and operational units for each body.
has a major impact on the treatment of diseases [16, 17]. A broad
spectrum of biological action was observed by the application ● Electromagnetic reading, writing and blocking of the
of exogenous electrical fields on single cells and tissues. Due potential for action.
to the cellular membrane’s high resistance to current flow, ionic ● Create a research system for the recording, stimulation and
currents caused by artificial external electrical fields are forced blocking of chronic neural experiments.
to penetrate the cells and enforce a potential gradient across ● Start miniaturization to enable animal models to function
the surface of the membrane. It causes changes in membrane and spot the way for bioelectronic medicinal products.
protein function, orientation and ionic channel opening resulting ● Increase regional signal processing by setting pattern
in intracellular signalling pathways being stimulated. The signalling features and increasing the number of interface channels.
cascade affects gene expression that codes for proteins involved
3. Early establishment of therapeutic feasibility [24, 25]
in multiple biological functions including cell division, migration,
proliferation and embryogenesis. The gap junctions between The real therapeutic potential is the actual catalyst for the
cells, which are channels that link cell cytoplasms, often play an work. The collection of fundamental experiments should be
important role in applying electrical fields to generate a tissue- implemented. These should be supplemented by changing the
level response. This slow communication route could intensify the treatment codes for various signalling patterns in the nerves
cascade of intracellular signalling generated in response to the for more effective treatment of the disease.
potential changes. Signals circulate through the tissue, causing, for ● Use the body of rodent disease models to quickly prove
example, coordinated cellular response to wound healing or tissue the effect, given that the target circuit is similar to human
regeneration. The process is shown in Figure 4. For bone fracture innervations.
healing and osteoarthritis treatment, this method has been used ● Track neuronal and biomarker changes during disease
to promote chondrocyte and osteoblast regeneration. As a result, progression to classify functional relationships.
osteogenesis and bone mineral density changes are observed [18, 19]. ● Monitor the effect of chronic and acute blockage or
Principle research areas of bioelectronics: The principle stimulation at the specified stage of the disease.
research areas of bioelectronics are; ● Seek quick read-outs through visceral organs and functions
when sharing group findings.
1. Visceral nerve atlas development [20, 21] – It focuses on
visceral organ innervations including lungs, head, liver, ● Establish optimal points in a centered collection of model
pancreas, kidney, bladder, gastrointestinal tract, lymphoid organs for modulating the disease-associated function.
and reproductive organs. Mapping their complex innervations, ● Build the analogous dose-response curves of neural
including sympathetic, parasympathetic, sensory and enteric signaling patterns in the multi-dimensional space.
processes, which is important to achieve resolution at the level ● Review the effectiveness and side-effect profile of closed-
of nerve fibers and action power. The main features are: loop regulation in response to neural underlying signals.
● To produce resources to map from the fiber anatomy and ● Increase the collection of electrochemical, electrophysiological
taxonomy and to individual organs. and immunohistochemical instruments to assess the
● Exploring inter and intra species neuroanatomy differences effect on visceral peripheral nerves of chronic electrode
and setting up optimal animal models for comprehensive implantation.
mapping of each body. ● Examine the visceral nerve immune response while dealing
● In the representative animal model, we need to build high- with various systems and materials.
resolution and organ centered maps. ● Determine the degree of neurological damage and plasticity
● Provide scanning methods and finding nerves in each in response to chronic neuromodulation (anatomical and
organ and simultaneously produce records of neural signal physiological).
patterns and functions of the organ. ● Long-term map of neuromodulation adaptations across
● Create correlation and causation between the patterns of connected organs and functions.
neural signals and the functions of individual organs.
Market of bioelectronic medicines:
● To literate as the interface technology’s resolution and
performance increase before usable units are calculated. Owing to increased regulatory approvals for bioelectric medicine
products, the global bioelectric medicine market size is expected
● Establish standards for data collection, central archives
permitting for data mining and re-analysis to experience significant growth during the forecast period. As
an example, In 2015 Medtronic received the USFDA approval for
2. Advancement of interface technology [22-23] Evera MRI (implantable defibrillator cardioverter system). This
The advanced interface technology i.e. neural interface system is used to perform MRI scans on any part of the patient’s

Pharma Times - Vol. 54 - No. 11, November 2022 8 Pharma Times - Vol. 54 - No. 10, October 2022 13
body without any restrictions on positioning. During the period of TABLE 1: LIST OF ELECTROCEUTICAL MARKETED PRODUCTS
2019–2026, the global market for bioelectric medicine is projected
Device Purpose/ use
to witness a CAGR of 7.2 percent due to increased investment in
Non-Invasive Electroceutical -
the development of bioelectric medicines. Medtronic Plc, in 2016
Devices
invested around US$ 2.224 million in advanced bioelectric medicine
research and development. Due to the high prevalence of epilepsy Implantable Electroceutical -
in the United States, North America is expected to hold a dominant Devices
position in the global bioelectric medicine market during this period. Cardiac Pacemakers And Arrhythmia
According to the Centers for Disease Control and Prevention (CDC), Implantable Cardioverter
nearly 3.4 million individuals in the U.S. population reported active Defibrillators Applications
epilepsy in 2015, for instance. It is estimated that the global market Spinal Cord Stimulators Chronic Pain, Failed Back
for electroceuticals / bioelectric medicine will hit USD 35.5 billion Applications Surgery, Ischemia
by 2025. The rise in the geriatric population is expected to be the Cochlear Implants Applications Sensorineural hearing loss
main driver of growth over the predicted period [26, 27]. A growing
[26, 27] Deep Brain Stimulators Parkinson’s Disease, Tremor,
number of disorders, including cardiac arrhythmias, Parkinson’s Applications Depression, Other Deep Brain
disease, Alzheimer’s disease, epilepsy and depression, are linked Stimulation Applications
to
to the
the aging
aging population.
population. Implantable
Implantable cardioverter
cardioverter defibrillators,
defibrillators, Transcutaneous
Transcutaneous Electrical
Electrical Treatment
Treatment Resistant
Resistant
cochlear
cochlear implants, cardiac pacemakers, and
implants, cardiac pacemakers, and spinal
spinal cord
cord stimulators
stimulators Nerve
Nerve Stimulators
Stimulators Applications
Applications Depression,
Depression, Other
Other
are
are among
among the
the sophisticated
sophisticated electroceuticals
electroceuticals that
that can
can be be utilised
utilised Transcutaneous
Transcutaneous Electrical
Electrical
to
to treat
treat these
these disorders.
disorders. The The other
other major
major factor
factor driving
driving thethe Nerve
Nerve Stimulator
Stimulator Applications
Applications
growth
growth of
of the
the electroceutical
electroceutical market
market is
is growing
growing innovation
innovation in in the
the Vagus
Vagus Nerve
Nerve Stimulators
Stimulators Epilepsy,
Epilepsy, Other
Other Vagus
Vagus Nerve
Nerve
development
development of of advanced
advanced bioelectrical
bioelectrical medicine,
medicine, a a list
list was
was given
given Applications
Applications Stimulation
Stimulation Applications
Applications
in
in Table
Table 1.
1. Medtronic
Medtronic plc plc (Ireland),
(Ireland), St.
St. Jude
Jude Medical,
Medical, Inc.Inc. (United
(United
States), Sacral
Sacral Nerve
Nerve Stimulators
Stimulators Urinary
Urinary Incontinence,
Incontinence, Fecal
Fecal
States), Boston
Boston Scientific
Scientific Corporation
Corporation (United
(United States),
States), Cochlear
Cochlear Applications Incontinence
Limited
Limited (Australia),
(Australia), Sonova
Sonova Holding
Holding AG
AG (Switzerland),
(Switzerland), LivaNova
LivaNova Applications Incontinence
PLC Retinal
Retinal Implants
Implants Applications
Applications Retinitis
Retinitis Pigmentosa
Pigmentosa
PLC (United Kingdom), Biotronik (Germany), Nevro
(United Kingdom), Biotronik (Germany), Nevro Corporation
Corporation
(United Other
Other Electrical Stimulators
Electrical Gastroparesis,
Gastroparesis, Obesity,
(United States),
States), Second
Second Sight
Sight Medical
Medical Products,
Products, Inc. Inc. (United
(United Stimulators Obesity,
States), Applications Depression,
Depression, Migraine,
Migraine, Spinal
States), and
and ElectroCore
ElectroCore LLC LLC are
are the
the major
major bioelectronic
bioelectronic medicine
medicine Applications Spinal
manufacturers Cord
Cord Injury
manufacturers (U.S.).
(U.S.). BioElectronics
BioElectronics Corporation
Corporation (US),(US), MED-EL
MED-EL Injury
(Austria),
(Austria), Cefaly Technology (Belgium), Stimwave LLC (US),
Cefaly Technology (Belgium), Stimwave LLC (US), Vomaris
Vomaris
Innovations,
Innovations, Inc.
Inc. (US),
(US), EnteroMedics
EnteroMedics Inc.Inc. (US),
(US), NeuroSigma,
NeuroSigma, Inc. Inc.
(US), disorders
disorders ofof blood
blood flow
flow in
in the
the upper
upper and
and lower
lower limbs,
limbs, arthritis,
arthritis,
(US), Oticon Medical (France), GlaxoSmithKline (UK), Medtronic
Oticon Medical (France), GlaxoSmithKline (UK), Medtronic Plc., Plc., Temporo-Mandibular
(Ireland),
(Ireland), Reshape
Reshape Life
Life sciences
sciences (US)
(US) are
are among
among thethe others
others [28, 29]..
[28, 29]
Temporo-Mandibular Joint syndrome (TMJ), nervous system
Joint syndrome (TMJ), nervous system
disorders,
disorders, diabetic
diabetic neuropathy
neuropathy pain pain and
and scleroderma
scleroderma may may all
all
Applications: benefit from
benefit from bioelectric
bioelectric treatment.
treatment. When
When used
used inin conjunction
conjunction
Applications:
with
with traditional
traditional pain
pain relievers,
relievers, bioelectric
bioelectric therapy
therapy hashas been
been
Chronic
Chronic diseases
diseases impact
impact large
large segments
segments of of the
the population
population withwith shown
shown to cut the dose of some pain relievers by up to 50%.
to cut the dose of some pain relievers by up to 50%. For
For
a
a rising social and economic burden. The bioelectronic revolution
rising social and economic burden. The bioelectronic revolution everyone,
everyone, bioelectrical
bioelectrical therapy
therapy is is not
not appropriate
appropriate viz.,
viz., patients
patients
aims
aims toto boost
boost the
the outcome
outcome andand quality
quality of
of life
life for
for patients,
patients, if
if implants
implants with
with pacemakers,
pacemakers, thrombosis,
thrombosis, bacterial
bacterial infections
infections and
and pregnant
pregnant
are
are designed quickly, they become less expensive than chronic
designed quickly, they become less expensive than chronic women. Studies have shown that targeting
women. Studies have shown that targeting inflammatory inflammatory
drugs.
drugs. InIn addition
addition to
to scientific
scientific and
and technical
technical innovation,
innovation, scientists
scientists reflexes
reflexes with
with VNS
VNS isis an
an effective
effective way
way of
of controlling
controlling inflammation
inflammation
and
and industry
industry need
need to to create
create creative
creative solutions
solutions to to make
make these
these tools
tools in
in a wide range of diseases. The vagus nerve, a
a wide range of diseases. The vagus nerve, a combined
combined nerve
nerve
affordable
affordable and available to patients who are most in need of
and available to patients who are most in need of them,
them, with afferent and efferent fibres, is distributed throughout the
regardless of their income and where they stay. Here giving the with afferent and efferent fibres, is distributed throughout the
regardless of their income and where they stay. Here giving the body from brain to feet; the sites are depicted in Figure 6. The
list of bioelectric devices or medicines used in various problems; body from brain to feet; the sites are depicted in Figure 6. The
list of bioelectric devices or medicines used in various problems; biological approaches to control the inflammation by stimulation
● Neuro-modulation of small peripheral nerves – biological approaches to control the inflammation by stimulation
● Neuro-modulation of small peripheral nerves – of the vagus nerve are shown in Figure 7. The Dorsal Motor
of the vagus nerve are shown in Figure 7. The Dorsal Motor
Flexible Neural Clip (FNC), a new implant can help to develop Nucleus (DMN) of the vagus nerve and the Nucleus Ambiguous
Flexible Neural Clip (FNC), a new implant can help to develop Nucleus (DMN) of the vagus nerve and the Nucleus Ambiguous
a wireless neural interface for application in bioelectronics (NA) in the brainstem (medulla oblongata) are where efferent
a wireless neural interface for application in bioelectronics (NA) in the brainstem (medulla oblongata) are where efferent
medicine. It is useful to modulate the basic physiological neurons of the vagus nerve begin and activate various visceral
medicine. It is useful to modulate the basic physiological neurons of the vagus nerve begin and activate various visceral
functions of organs or tissues to target three nerves viz., vagus organs. Postganglionic neurons interact with such lengthy
functions of organs or tissues to target three nerves viz., vagus organs. Postganglionic neurons interact with such lengthy
nerve, bladder nerve and sciatic nerve, which need small neural preganglionic neurons in close proximity within the innervated
nerve, bladder nerve and sciatic nerve, which need small neural preganglionic neurons in close proximity within the innervated
interfaces. The stimulation of pelvic vagus and bladder nerves organs [31-34] . Heart rate control, gastrointestinal motility and
interfaces. The stimulation of pelvic vagus and bladder nerves organs [31-34]. Heart rate control, gastrointestinal motility and
contributes to the exciting possibility of restoring a patient’s secretion, liver glucose output, and endocrine and exocrine
contributes to the exciting possibility of restoring a patient’s secretion, liver glucose output, and endocrine and exocrine
homeostatic physiological conditions. With the aid of novel FNC pancreatic secretion are the main physiological functions of
homeostatic physiological conditions. With the aid of novel FNC pancreatic secretion are the main physiological functions of
software, it is possible to investigate Heart Rate (HR) regulation, the vagus nerve. Acetylcholine (ACh) is released on target cells,
software, it is possible to investigate Heart Rate (HR) regulation, the vagus nerve. Acetylcholine (ACh) is released on target cells,
bladder function control and leg muscle contraction as shown such as smooth muscle cells, cardiac myocytes, and glandular
bladder function control and leg muscle contraction as shown such as smooth muscle cells, cardiac myocytes, and glandular
in Figure 5 by stimulating these nerves. In addition, active FNC cells, and interacts with muscarinic acetylcholine receptors
in Figure 5 by stimulating these nerves. In addition, active FNC cells, and interacts with muscarinic acetylcholine receptors
was also introduced as a type of wireless neural dust to provide to regulate these actions (mAChRs). Afferent neurons, which
was also introduced as a type of wireless neural dust to provide to regulate these actions (mAChRs). Afferent neurons, which
less remote bladder function modulation of the battery [30] . make up around 80% of the total number of neurons in the
less remote bladder function modulation of the battery [30]. make up around 80% of the total number of neurons in the
● Inflammation – vagus nerve, are also present. The nodose and jugular ganglia
● Inflammation – vagus nerve, are also present. The nodose and jugular ganglia
include pseudounipolar neurons, and their bidirectional axons
Complex regional pain syndrome (also known as Reflex include pseudounipolar neurons, and their bidirectional axons
Complex regional pain syndrome (also known as Reflex communicate peripheral (visceral) modifications to the Nucleus
Sympathetic Dystrophy (RSD), back pain, muscle pain, communicate peripheral (visceral) modifications to the Nucleus
Sympathetic Dystrophy (RSD), back pain, muscle pain, Tractus Solitarius (NTS) of the brainstem.
Tractus Solitarius (NTS) of the brainstem.
Pharma Times - Vol. 54 - No. 10, October 2022 14
Pharma Times - Vol. 54 - No. 10, October 2022 14 Pharma Times - Vol. 54 - No. 11, November 2022 9
 Fig. 2: First bioelectronic device

Fig. 1: Functional assemblies of biologics and electronics

Fig. 4: Different biological functions triggered by application of electric

fields a) single cell b) tissues

Fig. 3: Bulk ions vs faradaic conductance across the cell plasma

membrane

Fig. 5: Different applications of wireless FNC Fig. 6: Sites of vagus nerve in biological system

Pharma Times - Vol. 54 - No. 11, November 2022 10 Pharma Times - Vol. 54 - No. 10, October 2022 15
 Fig. 7: Bioelectric approach of targeting the vagus nerve to control
inflammation

Fig. 10: Cholinergic nerve signaling promotes neonatal heart

regeneration and adult heart remodeling following cardiac injury

Fig. 8: Neuroimmune circuits in the treatment of arthritis

Fig. 11: Various bioelectronic devices

Figure 8 depicts the possible therapeutic application of neuro-

immuno circuits in the treatment of arthritis. The efferent vagus
nerve can decrease inflammation by activating the splenic
nerve (A) via a neuro-immune system that includes 7-nAChR
expressing mesenteric ganglia (B) and T cells that produce
splenic acetylcholine. A technique based on locus coeruleus
activation (F) followed by splanchnic nerve stimulation (E)
or synovial sympathetic innervations can prevent local joint
inflammation via afferent vagal impulses (C&D), sympathetic
C1 neurons (G), and cortical stimulation (H). A method based
Fig. 9: Methods for stimulating and sensing of the nervous system on a 7-nAchR expressed in macrophage/fibroblast increases
local inflammation in an articular non-neuronal cholinergic

Pharma Times - Vol. 54 - No. 10, October 2022 16 Pharma Times - Vol. 54 - No. 11, November 2022 11
 system (C), but a neural adrenergic system reduces local because of the required surgery and reliance on transcutaneous
inflammation through mechanisms (D) that are either directly electrical tethering. Recent advancements, on the other hand,
(β-adrenoceptors) or indirectly (IL-10-producing B lymphocytes). have resulted in fully integrated wireless ECoG systems that
According to a recent notion, peripheral T-cells that move to can enable more functional activities. The fact that activity
organs (such as the spleen) after vagal stimulation (I) create monitoring is limited to the cortex’s outer surface limits CNS
non-neuronal acetylcholine [35-38]. motor activity resolution, which is a key drawback of EEG and
● Spinal cord injury - A new approach to an electrical-based ECoG technology. To boost the degree of functioning, interfaces
medicine is epidural stimulation restoring the voluntary motor that connect with CNS structures may be required. There are,
feature in the lower limbs of a specific patient cohort. Because however, major obstacles to long-term BMI implants [41-43].
of the recent growth of soft electronic materials, new ways to ● Cardiac problems –
neuromodulate have been developed to minimize secondary Figure 10 depicts the influence of bioelectric medicine or
harm, bypass trauma, or as a therapy for motor function devices on heart function. It explained how the heart of a
recovery. Nonetheless, existing technology is trapped by a newborn mouse and an adult mouse worked. The neonatal
linear relationship between signal resolution and invasiveness. mouse heart may heal after injury, and it has been discovered
A combination of novel materials, signal processing techniques that successful heart regeneration is dependent on cholinergic
and stimulation modalities will be necessary to address nerve communication. Cardiomyocyte proliferation was reduced
current flaws. Recent developments in algorithms, robotics and regeneration was lost as a result of the pharmacological
and recording technology helped to advance neuroprosthetic and mechanical blockade of cholinergic neurons. Adults with
systems in the Brain Machine Interface (BMI) [39, 40] . The
[39, 40]
chronic heart failure treated with vagus nerve stimulation
instruments are an example of the story for recording/sensing demonstrated some improvements in heart function in these
or stimulation. The methods for stimulating and sensing the preliminary clinical studies. The mechanisms behind the
nervous system are shown in Figure 9. positive function of vagus nerve stimulation in heart healing
To
To tt rr a
a cc k
k aan ndd rr ee cc o
o rd
rd b b rr a
a ii n
n a a cc tt ii vv ii tt yy n noonn ii nva
nva ss ii veve ll yy are
are still
still not
not fully
fully understood.
understood. Nonetheless,
Nonetheless, it it is
is thought
thought that
that
Electroencephalography
Electroencephalography (EEG) (EEG) is is used.
used. It It was
was invented
invented by by VNS’s
VNS’s positive
positive effect
effect is
is mediated
mediated in in part
part by
by increased
increased AChACh
Richard
Richard CatonCaton in in 1875
1875 and and tested
tested on on people
people by by Hans
Hans BergerBerger signalling
signalling in in macrophages
macrophages via via binding
binding to to 7-nAChR.
7-nAChR. This
This leads
leads
in
in 1924.
1924. LargeLarge surface
surface electrodes
electrodes (>10 (>10 mm2) mm2) as as partpart of of a a to
to a a reduction
reduction in in pro-inflammatory
pro-inflammatory cytokine
cytokine release
release and,
and, as
as aa
protective
protective cap or individual electrodes put by hand are used to
cap or individual electrodes put by hand are used to result, a reduction in the heart’s fibrotic response to remodelling
result, a reduction in the heart’s fibrotic response to remodelling
measure
measure EEG. EEG. EEG
EEG recordings
recordings are are dominated
dominated by by low-frequency
low-frequency
[44, 45].
[44, 45]
.
oscillations
oscillations withwith most
most theta
theta (4-7
(4-7 Hz), Hz), alpha
alpha (8-12 (8-12 Hz),Hz), and/or
and/or ●
● Cancer therapy
Cancer therapy – –
beta
beta (15-30
(15-30 Hz) Hz) based
based testing
testing and and neuroprosthetic
neuroprosthetic devices devices Cancer
Cancer therapy
therapy may
may potentially
potentially benefit
benefit from
from the
the usage
usage of of electric
electric
due
due toto the
the nature
nature of of multipopulation
multipopulation operation. operation. In In 1D,
1D, 2D, 2D, and and fields.
fields. The
The changes
changes in in resting
resting membrane
membrane potential
potential between
between
3D
3D changes
changes in in these
these rhythms
rhythms were were employed
employed to to operate
operate the the tumor
tumor and and non-tumor
non-tumor cellscells have
have been
been discovered
discovered in in several
several
computer
computer and and virtual
virtual object
object cursors.
cursors. Robotic Robotic arms arms were were alsoalso investigations.
investigations. Depolarized membranes are commonly observed
Depolarized membranes are commonly observed
controlled
controlled by by EEG
EEG recordings,
recordings, which which may may be be hampered
hampered by by noise
noise in
in cells
cells with
with strong
strong proliferative
proliferative activity,
activity, such
such asas embryonic,
embryonic, stem stem
created by eye movements and facial
created by eye movements and facial muscle contractions, muscle contractions,
and
and metastatic
metastatic cells.
cells. Metastatic
Metastatic phenotypes
phenotypes can can be be activated
activated in in
disguising
disguising brainbrain signals
signals and and necessitating
necessitating complex complex processing
processing healthy
healthy cells
cells by
by depolarizing
depolarizing their
their membranes
membranes and and thethe formation
formation
and
and algorithms
algorithms to to interpret
interpret useful
useful information.
information. In In addition,
addition, the the of
of a a metastatic
metastatic cell
cell caused
caused byby oncogenes
oncogenes can can bebe prevented
prevented by by
number
number of of electrodes
electrodes and and their
their positioning
positioning can can cause
cause signalsignal blocking
blocking their
their depolarization.
depolarization. Electric
Electric fields
fields have
have beenbeen shown
shown
confusion.
confusion. Magnetoencephalography
Magnetoencephalography (MEG), (MEG), an an alternative
alternative to
to improve
improve the
the outcomes
outcomes of of cancer
cancer patients
[46].
patients [46].
to
to EEG,
EEG, usesuses a a variety
variety of of magnetometers,
magnetometers, such such as as SQUIDs,
SQUIDs, to to
record ●
● Other
Other applications
applications –
record magnetic
magnetic fieldsfields created
created by by electrical
electrical currents currents in in the
the brain
brain –
(superconducting
(superconducting quantum quantum interference
interference devices). devices). MEG MEG signalssignals Bioelectronics
Bioelectronics can can be be used
used toto construct
construct organic
organic tissues
tissues like
like
have
have also been utilised to accurately monitor and anticipate
also been utilised to accurately monitor and anticipate the
the nose, skin and tongue as demonstrated in Figure 11.
nose, skin and tongue as demonstrated in Figure 11. The
The
3D
3D motions
motions in in humans
humans using using a a high-density
high-density range range (248 (248 bioelectric
bioelectric medicines
medicines whichwhich are
are under
under clinical
clinical trials
trials are
[47-49]
are [47-49]
sensors)
sensors) and and a a 2D
2D joystick.
joystick. The
The needneed for for a a noise-free
noise-free recording i.i. In
recording In epilepsy,
epilepsy, anan implanted
implanted device
device (Cyberonics®/
(Cyberonics®/ Livanova) Livanova)
environment
environment for for rather
rather big big pieces
pieces of of imaging
imaging equipment, equipment, as reduced
as reduced the generation of IL-1 and IL-6
the generation of IL-1 and IL-6 inin whole
whole blood
blood
well
well as specific shielded areas, are also disadvantages of
as specific shielded areas, are also disadvantages treated
of treated with
with lipopolysaccharides.
lipopolysaccharides.
MEG.
MEG. Low-frequency
Low-frequency oscillations
oscillations are are reported
reported via via an
an implanted
implanted ii.
electrode ii. GammaCore
GammaCore (cervical
(cervical vagus
vagus nerve
nerve stimulator)
stimulator) for for a a variety
variety
electrode arrayarray within
within thethe skull
skull known
known as as electrocardiograms
electrocardiograms of
of primary
primary headaches,
headaches, including
including migraine
migraine and and cluster
cluster
in
in order to increase precision and reduce the
order to increase precision and reduce the requirement
requirement headaches.
for headaches.
for specialist equipment only available in hospitals (ECoGs).
specialist equipment only available in hospitals (ECoGs). iii.
ECoG iii. An
An Auricular
Auricular Branch
Branch Vagal
Vagal Stimulator
Stimulator (Nemos®)
(Nemos®) device device forfor
ECoG arrays
arrays feature
feature a a higher
higher spatial
spatial resolution
resolution (hundreds (hundreds of of drug-resistant
microns drug-resistant patients who want to reduce their seizure
patients who want to reduce their seizure
microns to to millimetres),
millimetres), a a wider
wider recording
recording bandwidth bandwidth (0-200 (0-200 frequency.
frequency.
vs.
vs. 0-40
0-40 Hz),Hz), aa larger
larger maximum
maximum signal signal amplitude
amplitude (50-100 (50-100 vs. vs.
10-20
10-20 V), and significantly less susceptible to muscle and
V), and significantly less susceptible to muscle and other
other CONCLUSION:
electrical CONCLUSION:
electrical distortion
distortion thanthan EEG.
EEG. ECoG
ECoG has has been been used used to to regulate
regulate We
prosthetic We discussed
discussed thethe milestones
milestones of
of bioelectronics
bioelectronics and
and some
some of of
prosthetic devices in both NHP and human subjects as
devices in both NHP and human subjects as a a BMI.
BMI. the
Rapid improvements to ECoG electrode arrays have been made the applications of bioelectric medicines to chronic diseases in
applications of bioelectric medicines to chronic diseases in this
this
Rapid improvements to ECoG electrode arrays have been made review paper. It is a growing field and significant progress is being
possible, thanks to recent breakthroughs in polyimide-based review paper. It is a growing field and significant progress is being
possible, thanks to recent breakthroughs in polyimide-based made in the treatment and diagnosis of disease. Nonetheless,
microfabrication technology. Individual finger articulations were made in the treatment and diagnosis of disease. Nonetheless,
microfabrication technology. Individual finger articulations were in order to produce less invasive approaches, bioelectrochemical
recently monitored using high-density ECoG electrode arrays. in order to produce less invasive approaches, bioelectrochemical
recently monitored using high-density ECoG electrode arrays. therapies often need a multidisciplinary approach. Number of
The use of this technique in the clinic has been limited to date therapies often need a multidisciplinary approach. Number of
The use of this technique in the clinic has been limited to date

Pharma Times - Vol. 54 - No. 10, October 2022 17

Pharma Times - Vol. 54 - No. 11, November 2022 12 Pharma Times - Vol. 54 - No. 10, October 2022 17
Article

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28. Nicolini C. From neural chip and engineered biomolecules to bioelectronic
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Pharma Times - Vol. 54 - No. 10, October 2022 18 Pharma Times - Vol. 54 - No. 11, November 2022 13
Article

INTRODUCTION TO NUTRACEUTICALS AND ITS REGULATORY

REQUIREMENTS IN INDIA
Swathi J. B. Pharm, Dr. D. Nagasamy Venkatesh PhD,
Regulatory Affairs, Department of Pharmaceutics,
JSS College of Pharmacy, Ootacamund, The Nilgiris, Tamil Nadu.
(Affiliated to JSS Academy of Higher Education and Research)

Abstract
Background: The Nutraceuticals market has an emerging growth globally since they show marked effects. Nowadays, the maximum
population is focused towards healthy eating which paved the way for the use of nutraceuticals. Nutraceuticals are food or part of
food which is given in the form of tablets, pill etc. for the prevention and treatment of various chronic diseases and usually consists of
essential nutrients such as vitamins, minerals, proteins, carbohydrates and lipids, which are available in the form of powders, capsules,
pills as a single or combination preparation.
Aim: The aim of this review article is to know about nutraceuticals and its regulatory requirements in India.
Methods: A review of the nutraceuticals with their therapeutic action, regulatory status in India and global regulations in nutshell.
Articles were first chosen by the inclusion of articles related to nutraceuticals, functional foods and dietary supplements, followed by
Indian regulations.
Results: Thirty-four articles were reviewed and in this article, the regulatory requirements for nutraceuticals in India are discussed. In
India, the Food Safety and Standard Authority of India (FSSAI) having its headquarters in Delhi, governs the food and nutraceuticals
manufacture and import registration. The registration procedure in India is differentiated into three types: basic, state and central
registration.
Conclusion: It is found that the nutraceutical market is increasing in India and other parts of the world and the regulatory requirements
for nutraceuticals differ from one country to another.
Keywords: Nutraceuticals, Regulatory Requirements, Therapeutic Approach, Farmaceuticals, FSSAI.

Introduction supplements are not advised to be taken as the main course for
Nowadays, people are concerned more about their health a healthy life but they can be taken as a supplement. It cannot
and are aware of the consumption of fresh fruits, vegetables, be claimed to cure disease for example “cures heart disease”
plant-based diet and this is where nutraceuticals came into the and excessive supplement intake will lead to fatal outcomes.
picture the term “Nutraceuticals›› (nutrient means health-giving The common dietary supplements include vitamins, minerals,
and pharma means medicine remedy) was coined by Stephen De coenzymes, calcium, amino acids, fatty acids, herbal concentrates
Felice, the founder and chairman of the foundation For Innovation and extracts, phytochemicals, probiotics and dietary fibres [8].
in Medicine (FIM), located in Cranford, New Jersey in 1989 [1]. Medical foods are specifically used for the dietary management
Nutraceuticals are described as any product derived from a food of diseases (carbohydrates that have slow digestion are given for
source with additional health benefits used for the prevention of diabetes mellitus), under the supervision of the physician and are
disease [2]. Nutraceuticals usually consist of essential nutrients monitored closely [9]. Farmaceuticals are modified agricultural
like vitamins, minerals, proteins, carbohydrates and lipids, crops and animals which are produced using biotechnological
which are available in the form of powders, capsules, and pills methods [10].
as a single or combination preparation [3]. They play a vital role
Therapeutic Approach of Nutraceuticals:
in the prevention and treating conditions like hypertension,
high cholesterol, weight loss, diabetes, menopausal symptoms, Nutraceuticals are being consumed to prevent different diseases
digestive upsets, constipation etc [4]. Based on the sources, which help in controlling the severity of the disease by improving the
chemical constituents and pharmacologic actions, nutraceuticals body functions, health promotions including life span prolongation,
are classified as functional foods, dietary supplements, medical improving reproductive activities, renal and gastrointestinal health
food and farmaceuticals [5]. Functional foods constitute a part and also prevents diseases like cancer, obesity, osteoarthritis,
of the usual diet with marked benefits, which provides the oral diseases, Alzheimer’s and Parkinson’s disease, eye
essential amount of nutrients to the body and they are enriched disorder, cardiovascular conditions and diabetes mellitus [11].
and fortified food, and this process is termed nutrification [6].
The functional foods are further classified as traditional food,
which does not contain any added ingredients, they are natural Regulatory Requirements in India:
whole food (Omega-3-fatty acid in cold-water fatty fish, lycopene In India, food and nutraceuticals are governed by the Food
in watermelon) and non-traditional food for boosting their Safety and Standard Authority of India (FSSAI), head office in
nutritional value contain added nutrients and ingredients which Delhi, which came into existence in 2008, which was under the
are produced by agricultural breeding (calcium-fortified orange Food safety and standards act, 2006 which consolidates various
juice, rice and soybeans enriched with β-carotene) [7]. Dietary acts and orders like Prevention of food adulteration Act 1984,

Pharma Times - Vol. 54 - No. 11, November 2022 14

 Table 1: Types of nutraceuticals utilised for various disease conditions.
Disease Condition Nutraceuticals Therapeutic Action
Cancer: Some of the research studies Carotenoids, lycopene Antioxidant
demonstrated the nutraceuticals to prevent
Ginseng Anti-inflammatory
cancer having anti-mutagenic and anti-
carcinogenic properties .
[12]
β-carotene in yellow and orange fruits Anti-carcinogenic
& mutagenic
Cruciferous vegetables Reduces the chances of colorectal and
lung cancer
Garlic Reduces atherosclerosis and platelet
aggregation
Obesity: A condition where fat accumulation Linoleic acid, capsicum, psyllium Anti-obese
is excess in the body and this can be
Chitosan, caffeine, fenugreek, green tea, Reduces body fat
corrected by choosing the appropriate diet
curcumin, black gram, bottle gourd
[13]
.
Osteoarthritis: A chronic disease resulting in Banana, ginger, green tea, oats, Alleviate the complications
impaired joint pain and motion and intake pomegranate, bran, boswellia, omega-3
of some natural food helps in reducing the milk, curcumin, soybean, avocado
severity [14].
Oral disease: Odonto Nutraceuticals which Olive oil Reduces pain, stiffness and swelling
represent pleiotropic phytotherapeutic
Aloe Vera gel Heals mucosal wounds
agents (bioactive phytochemicals rich in
polyphenols, flavonoids) in dentistry help in Probiotics Prevents dental caries, gingivitis
preventing oral disease [15].
Alzheimer’s disease: Also known as primary β-carotene, lycopene, curcumin, lutein Anti-oxidant and delays development of
degenerative dementia or senile dementia and lavandula dementia
which leads to memory loss in women more Folic acid and B12 Reduces homocysteine level
than in men [16].
Parkinson’s disease: Caused due to Soybeans, stilbenes, vitamin C, D, E and Protects the progression of Parkinson’s
neurodegeneration, which damages the coenzyme Q10 disease
dopamine-releasing cells in the brain,
leading to difficulty in walking, muscle rigidity
and shaking which occurs usually in middle
age and adult people [17].
Eye disorders: Includes age-related macular Lutein (in corn, mangoes, carrots, Treatment of visual disorders
degeneration, cataract, diabetes retinopathy, tomatoes) and Zeaxanthin (in corn, egg
glaucoma [18]. yolk, green vegetables and fruits)
Cardiovascular diseases: They are the Flavonoids, flavones, onion, cruciferous Reduces the risk of death by cardiovascular
primary cause of death and also cause vegetables, blackberries, cherries and problems
obesity, high blood cholesterol and blood apples
pressure and type 2 diabetes [19].
Diabetes mellitus: A condition with Psyllium Controls glucose level
abnormally high levels of blood glucose
Soy isoflavones, omega-3-fatty acids Lowers the incidence of diabetes
due to insulin insufficiency and this can be
controlled by altering the diet plan .
[20]
Fenugreek and cinnamon Treats diabetic neuropathy, nephropathy
and retinopathy

Milk & milk products order 1992, Food products order 1958, is done by the available online procedure. And finally, a single law
Meat food products order 1973, Vegetable oil products (control) is being implemented which regulates the manufacture, sales,
order 1947, Edible packaging (Regulation) order 1988, Solvent and distribution of food, nutraceuticals and dietary supplements
extracted oil, de-oiled meal and edible flour (control) order 1967. in India [22].
The main role of FSSAI is to frame the rules and regulations for
food and nutraceutical manufacturing companies [21]. The food FSSAI Licensing System:
safety and standard rules, 2011 were effective from 5th May, 2011 The food manufacturers should get registered or licensed by
to make mandatory registration of the food manufacturing facility the local authorities and the temporary holder can register their
under FSSAI. The import, export and manufacturing registration business with the local municipality. The licensing is of three types,

Pharma Times - Vol. 54 - No. 11, November 2022 15

they are the basic FSSAI registration, state FSSAI license and central FSSAI license. The validity of the license is 1-5 years and depending
on the choice of the food facility owner and is valid 30 days from the date of expiry [23].

Documents required for registration:

Basic FSSAI registration State FSSAI registration Central FSSAI registration
Application in Form A issued by the proprietor Form B (in duplicate) completed and signed Form B (in duplicate) completed and
signed
Photo identity of FBO (Food business operator) Blueprint/ layout plan of the manufacturing Names of the equipment and machinery
unit with the numbers
Rental agreement of premises Contact details and full address of the Address and identity proof issued by the
premises government authority
Certificate of incorporation/ partnership deed Names of the equipment and machinery List of directors/ partners/ proprietors
name with the numbers
List of food products Address and identity proof issued by the List of food categories to be manufactured
government authority
Food safety management system plan List of food categories to be manufactured In case the unit is export-oriented, a
certificate from the Ministry of Commerce
in this regard
The Authority letter with the name and address Authority letter which includes the name Proof of premises possession
of the proprietor and address
Supporting documents such as NOC (No The Analysis report issued by a recognized Source of raw materials used
objection certificate) by the municipality. public health laboratory
The power consumption of the equipment used Proof of premises possession IE code document issued by FSSAI
NOC certificate Source of raw materials used NOC certificate
Identity proof documents such as PAN card, Certificate of food safety management Authority letter which includes the name
passport, aadhar card and address
Proof of premises possession NOC certificate Self-declaration of the number of vehicles
used

Registration Process:
This basic FSSAI registration is required for all small-scale food businesses with annual income, not more than `12 lakhs, cottage
industries and temporary stakeholders [24]. After getting approval, the FSSAI logo and license number can be exhibited on the label of

the product and this mark is not a certification but is a valid license To check the criteria for
for food business operators under the Food safety & standard, Act registration

2006 [25]. The FSSAI license validity is between 1 to 5 years and File application to the
licensing authority in
should be renewed 30 days before the expiry and if the renewal is Form - A
filed beyond the date of expiry the applicant must pay a penalty of The supporting documents
are uploaded along with the
`100 for each delay day [26]. fees
Application received by the licensing authority
Benefits of FSSAI license: &
The submitted documents are verified
▪ Helps in expanding the business [27]. Rejection
of the
▪ Safety of the food facility in storage, distribution, sale and import Inspection done by the
licensing authority
application
etc [28].
▪ FSSAI logo, which improves goodwill among the customers [29]. Approval of the application

▪ Creates customer awareness.

Filing of the application
to the licensing authority
Regulatory Agencies governing nutraceuticals and dietary in Form - B
supplements globally: Issuing of unique
application number
In USA, the Food and Drug Administration (FDA) governs
food, nutraceuticals and dietary supplements and it’s the sole
responsibility of the manufacturers to ensure the safety of the License License
products before entering the market, according to the Dietary granted For incomplete
application, the rejection
Supplement Health and Education Act, 1994 (DSHEA) [30]. The queries are
forwarded
European Food Safety Authority (EFSA) governs food legislation
Manufacturers
in the EU through general food law Regulation 178/2002, shall start the
Inspection is done
the legislations established are Food supplements (Directive business after receiving the
missing information
2002/46), Fortified food (Regulation 1925/2006) and Nutrition

This basic FSSAI registration is required for all small-scale food businesses with annual
income, not more than ₹ 12 lakhs, cottage industries and temporary stakeholders [24]. After
Pharma Times - Vol. 54 - No. 11, November 2022 16
and health claims (Regulation 1924/2006) [31]. The Canadian of the scientific evidence. Arthritis Research & Therapy 8(4): 1-22.
Food Inspection Agency (CFIA) governs food safety in Canada, the 15. Oladeji Seye Julius, Kayejo Gbenga Victor.et al, (2020) Embrace
dietary supplements known as Natural Health Products (NHP) were Nutraceuticals and Live, Reject it and Embrace Death. Journal of
introduced in 2004 and are regulated under the Canadian Food Nutraceuticals and Food Science 5(1-2): 1-14.
& Drugs Act [32]. In Australia herbs, vitamins, minerals, nutritional 16. Anu Keshwani, Bhanu Malhotra.et al, (2015) Nutraceutical: A Drug,
supplements, homeopathy and aromatherapy are referred to as Dietary Supplement, and Food Ingredient. Current Pharmacogenomics
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Goods Act, 1989 which was implemented in 1991 [33]. Japan was 17. Chintale Ashwini G. et al, (2013) Role of nutraceuticals in various
the first to regulate nutraceuticals and the concept of Food for diseases: a comprehensive review. International journal of research
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by the Ministry of Health and Family Welfare [34]. 18. Swaroopa G. and Srinath D (2017) Nutraceuticals and their Health Ben.
International Journal of Pure & Applied Bioscience 5 (4): 1151-1155.
Conclusion
19. Shivendra Agarwal.et al, (2019) Nutraceuticals: As a dietary supplement
The quest for effective treatment and prevention has in health and disease. International Journal of Pharmacognosy and
increased in the area of nutraceuticals and more researchers are Pharmaceutical Sciences 1(1): 21-24.
being conducted to introduce modern approaches for treating
20. Darshika Patel.et al, (2008) Functional Food and Nutraceutical
chronic diseases. The nutraceutical market has emerging growth Registration Process in Japan and China: Similarities and Differences.
worldwide. Various companies in India, have started the food and J Pharm Pharmaceut Sci 11(4): 1-11.
nutraceuticals manufacturing, distribution and marketing, hence it
21. Bhawna Verma and Harvinder Popli (2018) Regulations of nutraceuticals
is very important to comply with the regulation. It is observed that
in India & us. The Pharma Innovation Journal 7(7): 811-816.
the registration process is more time-consuming when compared
22. Deepak Kaushik.et al, (2015) Marketing nutraceuticals in India:
with other countries. Frequent audits must be conducted by the
an overview on current regulatory requirements. Asian Journal of
FSSAI to ensure food safety. It is very important to get FSSAI
Pharmaceutical and Health Sciences 5(1): 1167-1171.
registration and license for the medium to top-level scale food
business. 23. Baby Chauhan.et al, (2013) Current concepts and prospects of
herbal nutraceuticals: a review. Journal of Advanced Pharmaceutical
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Nutraceuticals and Nutravigilance- Present Scenario in India. risks and regulatory scenario. International Journal of Pharmacy and
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2. Namdeo Shinde, Bhaskar Bangar, Sunil Deshmukh.et al, (2014) 25. Jinish Dhar M and S.B. Puranik (2018) Regulatory requirements
Nutraceuticals: A Review on current status. Research Journal of for registration, import, and manufacture of dietary Supplements
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Opportunity of Healthcare. PharmaTutor 6(8): 9-16. India registration and benefits of FSSAI license. Paripex- Indian Journal
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7. Patil C.S (2011) Current trends and future perspective of nutraceuticals
in health promotion. BIOINFO Pharmaceutical Biotechnology 1(1): 1-7. 29. Jain Pooja N.et al, Current Regulatory requirements for Registration
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of pharmacy and pharmaceutical sciences 6(8): 681-739. 32. M Arora and A. Baldi (2015) Regulatory categories of probiotics
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Pharma Times - Vol. 54 - No. 11, November 2022 17

Article

A REVIEW ON CHRONOTHERAPY & THE ROLE OF

CHRONOTHERAPEUTIC DRUGS
G J Vaishnavee1, Aasiya Nahas2, Dr Deepu S3
M.Pharm, Department of Pharmaceutics, Mar Dioscorus College of Pharmacy, Alathara, Sreekaryam, Thiruvananthapuram, Kerala
ABSTRACT 1. Drug administration time of the day.
Chronotherapy mainly deals with the circadian rhythm of the human 2. Patient's sleep
body. patterns and normal habits.
Chronotherapeutic deals with the treatment method in
3. Biological factors.
which, the drug availability is timing to match rhythms of disease to increase the therapeutics outcomes and minimize its side effects.
Chronotherapy drug delivery system is rapidly developing in theCHRONOTOXICITY:
field of pharmaceutical technology.
The study As it reduces
of the interaction the dosing,
between biological rhythmfrequency,
of the body and
toxicity and delivers the drug at the accurate time at the specific site1
. Circadian
toxic substances. rhythms are physical, mental, and behavioral changes that
follow a daily cycle. There are different types of biorhythms like circadian, ultradian, infradian, circalunar, and circannual. Chronotherapy
CHRONOPHARMACOKINETICS:
is used in the treatment of various diseases like hypertension, asthma, epilepsy, cancer, depression The study about how
etc. Some the absorption, distribution,
chronotherapeutic drugs
metabolism and elimination (ADME) of drugs relates to the time at which the drug is administered.
available in the market are Theophylline, Doxorubicin, Simvastatin, Nifedipine etc. The main advantage of the chronotherapy to the
patient is mainly due the convenience and compliance of the dosage form.
CHRONOTHERAPY: It is used in the treatment of hypertension, asthma depression etc.

Keywords: Chronotherapy, Circadian rhythm, Asthma, Hypertension, Cancer

INTRODUCTION
The science deals with the phenomenon of biological
rhythmicity in all living organism are known as chronobiology. The
study of chronobiology is known to be chrono pharmacology. Chrono
pharmacology is the study about how the effect of drugs varies with
biological timing and endogenous periodicities. The main aim is to
improve our understanding the desired effects and tolerance of
medications. It is useful to solve problems of drug optimizations.
It is the investigative science deals with the effects of drugs upon
the timing of biological events and rhythms. It also links effects of
drugs on biological timing to get the dynamic activity. The chrono
pharmacology deals with chronotherapy, chronopharmacokinetic
and chrono toxicity2.
CHRONOTHERAPEUTICS: Chronotherapeutic deals with the 8. Increased patient compliance.
treatment method in which, the drug availability is timing to match DISADVANTAGES
ADVANTAGES OF CHRONOTHERAPY OF CHRONOTHERAPY
rhythms of disease to increase the therapeutics outcomes and1. It reduces 1. Person
unnecessaryundergoing
side effect. therapy may feel unusually hot or cold.
minimize its side effects. Food and Drug Administration (FDA) has2. To solve2. problem
Personofbecome
drug optimization.
less productive during chronotherapy and
suggested that the additional parameters for chronotherapeutic3. It requiresdepriveno drug. of sleeps.
clinical studies are as follows: 4. It is more effective when a person sleeps for several hours.
5. Help 3. Theout
in caring person staying
the treatment awakeperiod.
for limited for the other schedule.
1. Drug administration time of the day.
4. Medical
6. Reduction supervision is necessary for the therapy.
in dosing frequency.
2. Patient’s sleep patterns and normal habits.
5. Regular consulting of sleep specialists is recommended3.
3. Biological factors. 2
IDEAL CHARACTERS OF CHRONOTHERAPY
CHRONOTOXICITY: The study of the interaction between 1. Non-toxic
biological rhythm of the body and toxic substances.
2. Must have a real time and specific triggering biomarker for
CHRONOPHARMACOKINETICS: The study about how the a given disease state.
absorption, distribution, metabolism and elimination (ADME) of 3. Should have a feed back control on the system.
drugs relates to the time at which the drug is administered. 4. Biocompatible and biodegradable.
CHRONOTHERAPY: It is used in the treatment of hypertension, 5. Easy to manufacture and to administer in to patients to
asthma depression etc. enhance the effect of dosage regimen.
ADVANTAGES OF CHRONOTHERAPY CIRCADIAN RHYTHM
1. It reduces unnecessary side effect. Circadian, the term was coined by Franz Halberd from Latin
2. To solve problem of drug optimization. words ‘circa’ means about and ‘diem’ means day. Circadian
3. It requires no drug. rhythms are physical, mental, and behavioral changes that follow
4. It is more effective when a person sleeps for several hours. a daily cycle. They primarily respond to darkness and light in an
organism. They are mainly found in living things like animals,
5. Help in caring out the treatment for limited period.
plants, and many tiny microbes. Circadian clocks interplay between
6. Reduction in dosing frequency. the environment and the physiologic processes4. It regulates
7. Reduced fluctuations in circulatory drug levels many body functions like metabolism, physiology, sleep patterns,

Pharma Times - Vol. 54 - No. 11, November 2022 18

 CIRCADIAN RHYTHM IN THE PATHOGENESIS OF DISEASE

behavior, hormone production etc. in human. Biorhythms are mainly

regulated by the sunlight. There are different types of biorhythms
like circadian, ultradian, infradian, circalunar, and circannual.
Different types of the rhythms affecting human body:
1. Ultradian: Cycles shorter than a day.
2. Circadian: Cycle lasts for over 24 hours.
3. Circamensual: Cycle longer than 24 hours
4. Circannual: Cycle last for one year5.
Diseases that Require Pulsatile Delivery

8. Hypercholesterolemia
Chronotherapy mainly dealsulcer
9. Peptic with the circadian rhythm of the human body. Chrono pharm
drug delivery system playsdisorder
10. Mood an important role in the field of pharmaceutical technology as i
the drug at right dose at specific time at a specific site. It play important role in various
1. ASTHMA
like:
According to WHO, Asthma is a chronic disease characterized
by recurrent attacks of breathlessness and wheezing, which vary
1. Asthma in severity and frequency from person to person.
2. Cancer No one exactly knows the causes of asthma. Asthma symptoms
can occur at any time in life The symptoms may be occur 50 to 100
3. Hypertension
4. Epilepsy times more at night than day and in winter than summer. Asthma
is a common disease affecting between 1 and 18% of the world’s
5. Alzheimer’s disease
population in different countries. Some of the symptoms are:
6. ArthritisShortness of breath, Chest tightness, pain, or pressure, Wheezing,
Chronological Behaviour Drug Used 7. DiabeticsFatigue, being short-tempered or irritable, difficulty in breathing,
8. Hypercholesterolemia
choking sensations, constant coughing anxiousness. Management
Acid secretion is high in
DISEASES THAT REQUIRE PULSATILE DELIVERYafternoon H 2
Blocker 9. Pepticofulcer
asthma is a stepwise process. The most common drug used
and at night Fatigue, being
in short-tempered
Asthma or irritable,
is long acting difficulty
Theopylline. Andinthebreathing,
treatmentchoking
mainlysensations, con
10. Mood disorder
Increasing of attacks during night or Antihistamine, B2 coughing anxiousness.
depends on Management
the disease of asthma
severity 6
. is a stepwise process. The most common drug
CHRONOLOGICAL
at early morning antagonist in Asthma is long acting Theopylline. And the treatment mainly depends on the disease seve
DRUG USED 1. ASTHMA Chronotherapy: Bronchial asthma is a chronic inflammatory
BEHAVIOUR disorder of the airways. It is the most common chronic respiratory
BP is at its lowest during the sleep Nitroglycerine, calcium
According todisease.WHO,Bronchial asthma is
Asthma is a chronic a disease diseasewhichcharacterized
is concerned by recurrent at
Acid secretion is high in afternoon and
cycle & rises steeply during the early channel H2 blockers,
Blocker Chronotherapy: Bronchial
ACE asthma is a chronic inflammatory disorder ofwith
the airways. It i
morning at night Inhibitors breathlessness
most common andcircadian
the wheezing,
chronic whichThe
rhythm.
respiratory varysymptoms
disease.inBronchial
severity and frequency
of asthma worsen
asthma is a from
disease person
during
which to perso
is concerned
the early
circadian morning
rhythm.
7
The. symptoms of asthma worsen during early morning7.
IncreasingPain
of attacks
in theduring night or at pain in
morning & more NSAIDS,
Antihistamine, B2No one exactly knows the causes of asthma. Asthma symptoms can occur at any time in
antagonist
theearly
night morning Glucocorticoids symptoms
The drugs beThe
mayused occurdrugs
50 to
in asthma used
100in
mainly asthma
times
include more mainly andinclude
at night
inhaled than
oral inhaled
day and inand
corticosteroids andoral
winter than summer
cysteinyl-leukot
BP is at its lowest during the sleep receptor corticosteroids
antagonist. Long and cysteinyl-leukotriene
acting theophylline is receptor
currently used antagonist.
for the Long of asthma. S
treatment
Nitroglycerine, calcium is a common
channel disease affecting between 1 and 18% of the world’s population in different c
blockers,
acting
Increase
cycle & rises steeplytheduring
bloodthe
sugar
earlylevel after Sulfonylurea, Insulin
Some concentration
of the of theophylline
symptoms the drug theisblood
currently
are:inShortness
used
is high for early
at the the treatment
morning8.of pain,
asthma.
meal morning ACE Inhibitors So, the concentration of theofdrug
breath,
in theChest
bloodtightness,
is high at the early or pressure, W
morning . 8

Pain in the morning & more pain in 5

NSAIDS, Glucocorticoids
CIRCADIANthe nightRHYTHM IN THE PATHOGENESIS OF DISEASE
Increase the blood sugar level after
Chronotherapy mainly deals with the Sulfonylurea,
circadian rhythm of the
Insulin
human body. meal Chrono pharmaceutical drug delivery system plays
an important role in the field of pharmaceutical technology as its
deliver the drug at right dose at specific time at a specific site. It
play important role in various diseases like:
1. Asthma
2. Cancer 4
3. Hypertension
4. Epilepsy
5. Alzheimer’s disease
6. Arthritis
7. Diabetics

2. CANCER Pharma Times - Vol. 54 - No. 11, November 2022 19

Cancer is a group of diseases which involves abnormal cell growth with the tendency to spre
 2. CANCER inhibiter (Angiotensin converting enzyme), Angiotensin II antagonist,
Cancer is a group of diseases which involves abnormal cell alpha blockers etc are the drugs used to treat hypertension11.
growth with the tendency to spread to all parts of the body. Chronotherapy: Hypertension is the largest prevalence of 30-
According to the census conducted by WHO in 2018 it was proven 45% of all the cardiovascular risk factor. Antihypertensive therapy
that more than 120 cancers are present in the world. The most involves morning doses, which mainly reducing blood pressure at
common type of cancer is Prostate cancer, skin cancer, lung cancer, daytime.
leukemia, lymphoma cancer. It is caused by a multitude of factors.
Most of the minor causes of cancer may include prolonged exposure Drug efficacy is mainly dealing with the rhythmicity of the
to radiation, autoimmunity, and lifestyle9. physiological, biochemical, and behavioral processes. These
parameters mainly dependent on the circadian and the biological
There is no single sign that deals with the confirmation of the clock of the body. Circadian rhythms are a cost-effective strategy for
cancer. The main symptom of cancer includes, Low RBC count reducing cardiovascular risk. Mainly the drugs used in hypertension
in blood, Frequent and narrow urine flow, Blood in stool, Swollen are given at bedtime. Antihypertensive drug is available at low cost
lymph node, hoarseness of throat, Blood in urine, Weakened bone. and simple.
Drugs used are Methotrexate, Carboplatin, Doxorubicin, 5 Fluro 4. PEPTIC ULCER:
Drugs used are Methotrexate,
uracil, BusulfanCarboplatin,
10
. Doxorubicin, 5 Fluro uracil, Busulfan 10.
According to WHO peptic ulcer may be defined as the lesion in
Chronotherapy: The main aim of Cancer chronotherapy is to increase the efficacy and tolerability(mucosa) of the digestive tract, mainly in the stomach or
Chronotherapy: The main aim of Cancer chronotherapy is to the lining
increase the efficacy and tolerability of anticancer drugs through duodenum, caused by the digestive action of pepsin and stomach
of anticancer drugs through their delivery according to circadian rhythm. The synthesis of DNA is
their delivery according to circadian rhythm. The synthesis of DNA acid.
more at midnoon, so drugs are mainly given at afternoon.
is more at midnoon, so drugs are mainly given at afternoon.
Gastric acid secretion may be highest during night; due to
this secretion the bowel motility and gastric emptying are slower
at night. Suppression of gastric acid is an important factor in the
healing duodenal ulcer. The drug used for duodenal ulcer, daily
H2 Antagonist once at bedtime. Giving H2- receptor blockade at
Bedtime can overcome the problems of intragastric acidity, enteric
infection and infestation.
DRUGS USED IN CHRONOTHERAPY FOR VARIOUS DISEASES
Sl. DRUG DISEASE
NO

1 Furosemide Hypertension

2 Salbutamol sulphate Nocturnal asthma

3 Indomethacin. Ibuprofen, Rheumatoid arthritis

Meloxicam, Aceclofenac,
3. HYPERTENSION
Prednisolone,
Hypertension is defined as an increased elevation of
3. HYPERTENSION
systolic blood pressure (SBP) more than 140 mm Hg and 4 Sulphonyl urea, Insulin Diabetes Mellitus
Mainly diastolic blood
the drugs used in as pressure (DBP)
hypertension are more
given than 90Antihypertensive
atofbedtime. mm Hg.  High blood
drug is available at
Hypertension is defined
pressure an increased
is called elevation
hypertension. systolic
Low bloodblood pressure
pressure is (SBP)
calledmore than
5 140 Glipizide,Gliclazides Type 2diabetes
ow cost and simple.
mm Hg and diastolic bloodThe
hypotension. pressure
normal(DBP)
bloodmore than 90
pressure mm from
ranges Hg. High blood pressure
120-80mm Hg is called
6 Nifedipine Angina
hypertension. Low blood pressure is called hypotension. The normal blood pressure ranges from
The main causes of hypertension are excess salt, Stressed
120-80mm Hglife, abnormal arteries. Due to these causes the symptoms of 7 Nitroglycerine Heart attack
hypertension are headache, nose bleeding, flushing, dizziness. ACE
.The main causes
PEPTIC ULCER: of hypertension are excess salt, Stressed life, abnormal arteries. Due to 8 theseOmeprazole, Famotidine, Ulcer
causes the symptoms of hypertension are headache, nose bleeding, flushing, dizziness. ACE Ranitidine
inhibiter (Angiotensin converting enzyme), Angiotensin II antagonist, alpha blockers etc are the
9 Fulminic acid, Methotrexate Cancer
drugs used to treat hypertension11.
5. HYPERCHOLESTEROLEMIA:
Chronotherapy: Hypertension is the largest prevalence of 30-45% of all the cardiovascular risk
Hypercholesterolemia can be defined as the elevation of
factor. Antihypertensive therapy involves morning doses, which mainly reducing blood pressure
at daytime. total cholesterol or low-density lipoprotein cholesterol or non-HDL
cholesterol in the blood; it is otherwise called as dyslipidemia .
12

Drug efficacy is mainly dealing with the rhythmicity of the physiological, biochemical,
The higher rates of cholesterol intake during the
and behavioral processes. These parameters mainly dependent on the circadian and thehypercholesterolemia
biological and hepatic cholesterol genesis occur
clock of the body. Circadian rhythms are a cost-effective strategy for reducing cardiovascular
duringrisk.
the evening hours. The free cholesterol levels have been
lowest at 2 p.m. to 6 p.m. and peak at 6 am. Thus, the drug used
for reducing the cholesterol (HMG-CoA reductase antagonists) was
According to WHO peptic ulcer may be defined as the lesion in the lining (mucosa) of the
igestive tract,Pharma
mainly inTimes
the stomach
- Vol.or
54duodenum, caused by the
- No. 711, November digestive
2022 20 action of pepsin and
omach acid.
Gastric acid secretion may be highest during night; due to this secretion the bowel motility and
 LIST OF CHRONOTHERAPEUTICS DRUGS IN MARKET

Sl.
DRUG BRAND NAME DISEASE MANUFACTURES
No

1 DiltiazemHcl Cardizem La Hypertension Corporation Barbados (KN)

2 Theophylline Unhiply extended release tab Asthma Glenmark Generics Incus

3 Simvastatin Zocor tab Hyper lipidemic Cipla Mumbai

4 Famotidine Gaster tab Ulcer Schwarz Pharma, Monheim, Germany

Isosorbide 5
5 IS5MN PM Angina pectoris CircPharma Ltd. Dublin, Ireland
Mononitrate

6 Bisoprolol Bisoprolol PM Cardio vascular disease Circ Pharma Ltd Dublin, Ireland

Pfizer lbs.U. Spharmaceuticals Groups, New

7 Nifedipine Procardia XL Hypertension and angina
York

8 Doxorubicin Rubex Cancer TCI Chemicals Ltd, Tamil Nadu, India

mainly given at evening time. Department Of Pharmaceutics) for providing the guidance and
support for publishing this article. I am highly thankful to my
6. DIABETICS
colleague Ms. Aasiya Nahas for her continues encouragement and
Diabetes is a disease that affects our body’s ability to produce
assistance for completing the article.
or use the hormone, Insulin. The cyclic rhythmicity of insulin is 8-30
min which can produce the optimal action. Protein that regulate REFERENCE
the biological clocks can also control the production of glucose in 1. Anafi RC, Lee Y, Sato TK, Venkataraman A, Ramanathan C, Kavakli
the liver and can Improve the health of diabetic patient. According IH, Hughes ME, Baggs JE, Growe J, Liu AC, et al. (2014) learning
to diurnal activity and feeding levels gluconeogenesis is regulated CHRONOTHERAPY. PLoS Biol 12: e100184
by cytochrome.so modulating the cytochrome can decrease the 2. Smolinsky M.H., Peppa’s N.A. Chronobiology, drug delivery, and
diabetics in patient13. chronotherapeutic. Adv. Drug delivery Rev.2007; 59:828-851. Doi:
10.1016/j.addr.2007.07.001
CONCLUSION
3. Altinok A, Levi F, Goldbeater A. (2009) identifying mechanisms of
The main goal of Chronotherapy is to achieve perfect therapy
chrono tolerance and chrono efficacy for the human. Eur J Pharm Sci
by targeting the drug to specific site at most appropriate time. 36:20- 38.
Improvement in the field of drug delivery has led to the development
4. Morris CJ, Aeschbach D, Scheer FA, Circadian system, sleep and
of pulsatile drug delivery system, which delivers the drug at right
endocrinology. Molecular Cell Endocrinology.2012;349:91-104
time, right place and right amount in the patient’s body.
5. A coli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP.
The pulsatile drug delivery system plays an important role (2003) The study of circadian rhythms. Sleep 26:342–392
in human by maintaining optimal concentrations at diseased
6. Asher G, Sassone-Corsi P. (2015) The intimate interplay of Asthma, and
condition. The timing of drug administration in disease therapy
the circadian clock. Cell 161:84–92
has an important impact on treatment. Nowadays chrono
pharmaceutics is to overcome drug delivery problems and present 7. Thomson NC, Patel M, Smith AD. Lebrikizumab in the personalized
management of asthma. Biologics. 2012;6:329–335
a greater patient compliance.
8. Aktas A. (2013) Cancer symptom cluster: Current concept of Asthmas.
Chronotherapy drug delivery system is rapidly developing CurrOpin Support Palliat Care 7:38-44.
the field of pharmaceutical technology and it reduces the dosing
9. A coli-Israel S. (2009) Recognition and treatment of cancer. J Clin
frequency, toxicity and delivers the drug at the accurate time. The
Oncol27:5864–5866
main advantage to the patient is mainly due the convenience
and compliance of the dosage form. The diseases which undergo 10. Schibler U. The daily timing of drugs in mammals. Dialogus clin
circadian rhythms are Hypertension, Cancer, Cardiovascular Neurosis. 2007;9;257-272
diseases, asthma, arthritis, ulcers, and diabetes. The technology 11. Crowley S. D., and Coffman T. M. 2007. In hypertension, the kidney
used in chronotherapy include Contin®, Chronotropic®, rules. Curr. Hypertension. Rep.9:148–153.
Pulsincaps®, Ceform®, Timerx®, Oros®, Codas®, Diffucaps®, 12. Baggs J.E., Hogenesch J.B. Genomics and systema approaches in the
Egalet®. mammalian circadian clock. Curr. Opin. Genet. Dev. 2010; 20:581-587.
Doi: 10.1016/j.gde.2010.08.009
ACKNOWLDGMENT
13. Kikuchi A, Okano T (2002) Pulsatile drug release control using
I am grateful to Dr. DEEPU. S (Associate Professor Of
hydrogels. Adv Drug Deliv Rev 54: 53-77.

Pharma Times - Vol. 54 - No. 11, November 2022 21

Pharma Times -- Vol.
Vol. 54
54 -- No.
No. 04-05, April-May
11, November 2022 2220
2022
Pharma Times
Pharma - Vol.
Times 54 54
- Vol. - No. 04-05,
- No. April-May 2022
11, November 2022 21
23
Article

Tropical disease priority review vouchers- A Review

Sanika Sangle, Dr. Muddukrishna B.S, Bhavin Modi, Dr. S G Vasantharaju*
Dept. of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences MAHE, Manipal, Karnataka, India
Abstract
The concept of Tropical Disease Priority Review Voucher (PRV) is one of the inventive strategies to influence the pharmaceutical
manufacturers to develop drugs for the marginalized population suffering from the neglected diseases. This is an award which is granted
upon the successful approval of a medicine developed for the neglected tropical disease. This can be used in turn to accelerate the
review procedure of another drug or transfer it to another company. There are advantages, limitations and proposals with respect to
the program which have been put forth in this review article. Most of the secondary data was collected from the following sources:
the review was carried out by reference to the officially published regulatory directives of the government, academic journals, online
journals, market research papers and newspaper articles available from the online library. This literature was compiled using a variety
of search engines, e.g. PubMed, Google Scholar, and a lot more.
Keywords: Neglected Tropical Disease (NTD), Priority Review Voucher (PRV), infectious disease

Introduction Table 1: Legislative history of PRV[5]

The United States Food Drug Authority (USFDA) grants Priority Sr. Year Events
Review Voucher (PRV) to promote research and development of no.
new medicines or biopharmaceuticals for the avoidance and cure 1. 2006 David B. Ridley, et. al published a paper in Health
of neglected tropical infections that are debilitating infectious Affairs proposing ND PRV’s basic idea
diseases affecting more than 1.5 billion citizens worldwide[1]. These 2. 2007 The Food and Drug Administration Amendments
diseases are a market that does not allow the pharmaceutical Act (FDAAA) introduced the PRV system in US
industry to recover its production costs[2]. The basic idea behind 3. 2012 The Food and Drug Administration Safety and
Innovation Act introduced the rare pediatric
this voucher: if a company develops a drug product for the tropical voucher
diseases mentioned in the list of tropical diseases then upon FDA
In 2012, Food and Drug Administration Safety
approval of the product would receive a voucher redeemable for a and Innovation Act (FDASIA) was signed by US
priority review for future application. Sponsors who win the tropical president Barack Obama, which provided the
disease PRV can use them to get priority. This voucher can be FDA with authority to grant PRV for treatments of
rare pediatric diseases[4]
transferred by selling it to another company which can then use
it to expedite the review of its own drug approval. This program 4. 2014 The amendments related to restriction on
voucher transfer and timing of FDA notification
has now been expanded to include rare pediatric diseases and were done
medicines countermeasures. 5. 2016 Through the 21st Century Cures Act, the
PRV Program was extended for pathogens of
Materials and Methods pandemic potential
Most of the secondary data was gathered from the following
sources: the analysis was carried out by reference to the officially
Terms and Definitions
released regulatory guidelines of the government, academic 1. Tropical disease (according to WHO):
journals, online journals, market research reports and newspaper Tropical diseases include all the contagious diseases occurring
articles accessible from the online library. due to the spread of viruses, bacteria, fungi, etc. occurring in tropical
and sub-tropical regions affected by unclean water, inaccessible
This literature was compiled using a variety of search engines, healthcare facilities, poor and marginalized communities. These
e.g. PubMed, Google Scholar, and a lot more diseases have been associated with economically vulnerable
nations causing misery in the form of disability, disfigurement and
Discussion death causing a never ending cycle of paucity[7].
Tropical disease priority review voucher was introduced in
2. Tropical disease priority review application:
the year 2007 by the US congress[3]. This programme is based ● Tropical disease priority review application is the one
on the paper published in Health Affairs in the year 2006 which is accepted by the FDA as eligible for prevention and
authored by David B. Ridley, Henry G. Grabowski and Jeffrey L. treatment of tropical disease[1].
Moe, a trio of Duke University[4,5]. They described the push pull ● It excludes any active pharmaceutical ingredient ( as well
mechanism designed to increase the funding for the Research and as its ester or salt) which has been already approved under
Development of infectious and parasitic diseases[6]. Eventually this section 505(b)(1) of the FD&C Act or section 351 of the PHS
voucher system was expanded to include rare pediatric diseases Act(1)[1].
(in the year 2012) as well as the medical countermeasures (in 3. Priority Review(PR):
the year 2016). Under section 524 of the Federal Food, Drug and
In the context of the FDA, the priority review prioritizes taking
Cosmetics Act (FD & C) authorizes FDA to bestow PRV upon those action on an application within six months instead of ten which is
companies which are eligible to receive it[5]. generally the case under standard review[8].

Pharma Times - Vol. 54 - No. 11, November 2022 24

 List of diseases eligible under the Tropical Disease Priority Requirements for new drug applications to apply for the Tropical
Review Voucher Scheme includes: Disease Priority Review Voucher:

Table 2: List of diseases eligible under the Tropical Disease The sponsor is expected to notify the FDA of the eligibility of
Priority Review Voucher scheme includes [9,10] the application for a priority review voucher through the original
application for a tropical disease product. Notification is not
Sr. Name of the Ntd Cause of the Ntd required before presenting the application.
No.
1. Tuberculosis (TB) Bacteria: Mycobacterium The following are the conditions under which the application
tuberculosis is deemed to be qualified:
2. Malaria Parasites: Plasmodium ● The treatment has been developed for the prevention and
parasite treatment of NTD[1].
3. Blinding trachoma Bacteria: Chlamydia ● The application is submitted under section 505 (b)(1) of the
trachomatis FD&C Act[1].
4. Buruli Ulcer Bacteria: Mycobacterium
● It excludes any the active pharmaceutical ingredient ( along
ulcerans
with its ester or salt) which has been already approved under
5. Cholera Bacteria: Vibrio cholerae
the section of 505(b)(1) of the FD&C Act or section 351 of the
6. Dengue/Dengue Virus: Dengue Virus (DENV)
PHS Act
haemorrhagic fever
7. Dracunculiasis (guinea- Helminth parasites: Guinea ● The application has been submitted after the enactment of
worm disease) worm FDAAA (September 27; 2007)[1].
8. Fascioliasis Parasite: Fasciola hepatica ● The application is qualified for priority review[1].
9. Filovirus (including Ebola) Virus: Cuevavirus,
● If the application is subjected to the drug-drug combination
(added to the list in 2014 Marburgvirus and Ebolavirus.
wherein one of the active moiety has not been approved already
by Congress)
under 505(b)(1) under other such applications.
10. Human African Parasite: Trypanosoma brucei.
trypanosomiasis (HAT) ● Even though the drug product which is subject to the application
11. Leishmaniasis Protozoa: Leishmania type has been approved and used in other countries but is being
● The application has been submitted after the[1]enactment of FDAAA
12. Leprosy Bacteria: Mycobacterium submitted to FDA 27;
(September for2007)
review[1] for the first time .
.
[1]
leprae ● The application
The conditions whichismake
qualified fornew
the priority
drugreview .
application ineligible
13. Lymphatic filariasis Helminth parasites: Filarial ● If the application is subjected to the drug-drug combination wherein one
for the Tropical Disease PRV:
worms of the active moiety has not been approved already under 505(b)(1)
● A tropicalunderdisease
other such applications.
drug product approved for another
14. Onchocerciasis Helminth parasites:
● Even
indication [1] though the drug product which is subject to the application has
.
Onchocerca volvulus been approved and used in other countries but is being submitted to FDA
15. Schistosomiasis Helminth parasites: blood ● Application for afor
for review new pediatric
the first time [1]. formulation already approved
flukes (trematode worms) ofThe conditions forwhich
adults make
[1]
. the new drug application ineligible for the Tropical Disease PRV:
the genus Schistosoma
● Application for a tropical disease drug product [1] presented to
16. Soil transmitted Helminth parasites: Different ● A tropical disease drug product approved for another indication .
helminthiasis types of roundworms ● Application for a new pediatric formulation already approved for adults524
the FDA prior to the date of promulgation of section [1] of the
.
FD&C for
● Application Acta tropical
(27 September
disease drug2007)productbut not yet
presented approved
to the FDA prioristovalid
the date
17. Yaws Bacteria: Treponema pallidum of promulgation
for a voucher of section
[1]
. 524 of the FD&C Act (27 September 2007) but not yet
pertenue approved is valid for a voucher[1].
18. Filovirus Diseases Virus: Cuevavirus, The transferability of PRVs:
Marburgvirus and Ebolavirus. ● The entitlement
The transferability of PRVs: of Tropical Disease PRV is transferable by the
19. Zika Virus Disease Virus: Zika sponsor to another sponsor of the company applying for human
(Congress added in ● The entitlement of Tropical
drug application and Disease PRV is transferable
is interested in buyingbyit.the sponsor to another
2016) sponsor of the company applying for human drug application and is interested in buying
it.● The process of transfer to Tropical Disease PRV:
20. Any other infectious ailment for which there is no ● The process
significant market in developed countries and which, by ● In● order In order of transfer the
to reclaim to Tropical Disease PRV:transfer archival
voucher, the cumulative
to reclaim the voucher, the cumulative transfer archival record
order of the Secretary, affects poor and marginalized record must be made available to the FDA.
must be made available to the FDA.
communities out of proportion. ● There is no limit
● There to the
is no limittransfer
to theof the voucher.of the voucher.
transfer
Table 3: Diseases added to the list by FDA[9]
Diseases added to the list by FDA The tropical disease product application holder presented with the
voucher
2015 2018
Chagas Disease Chikungunya Letter of transfer Letter of
acknowledgement
Neurocysticerosis Cryptococcal meningitis
Rabies Lassa fever
New Voucher Holder
Rabies
Tropical disease product application fees:
1. If It does not qualify the orphan drug designation i.e. not subjected to the treatment of
Pharma
less than 2 lakh patientsTimes - Vol.
in US then 54 - No.
A tropical 11,product
disease November 2022
application would25be
required to fulfill the legal requirements like any other human drug application. Section
736 of the FD&C Act contains a complete description of the user fees of the human
 Table 4: The status of the voucher awarded for the neglected tropical diseases [9,11]

Sr. Year Disease Product Company Application type Status of the voucher Used(U), not
no. used (NU), Transferred(T)
1. 2009 Malaria Coartem Novartis 505 (b)(1) NDA U-BLA-Ilaris-Canakinumab
(artemether/
lumefantrine)
2. 2012 Tuberculosis Sirturo (bedaquiline) Janssen (JNJ) 505 (b)(1) NDA U-Tremfya-Guselkumab
3. 2014 Leishmaniasis Impavido Knight 505 (b)(1) NDA T-Gilead Sciences for $125 million
(miltefosine) Therapeutics
4. 2016 Cholera Vaxchora PaxVax 351 (a) BLA T-Gilead Sciences-$200 million
Vaccine Bermuda
5. 2017 Chagas Benznidazole Chemo 505 (b)(2) NU
Research

6. 2018 Onchocerciasis Moxidectin Medicines 505 (b) T-Novo Nordisk for undisclosed sum
(river Development
blindness) for Global
Health
7. 2018 Malaria Krintafel GSK 505 (b)(1) U
(tafenoquine) NDA

8. 2019 Fascioliasis Egaten Novartis NDA NU

(triclabendazol)
9. 2019 Dengue Dengvaxia Sanofi 351 (a) NU
10. 2019 Tuberculosis Pretomanid TB Alliance 505 (b) NU

NU: Not Used, U: Used

Tropical disease product application fees: Table 5: Fees applicable for the human drug application
1. If It does not qualify the orphan drug designation i.e. not subjected to priority review voucher (2011-2020)[9]
subjected to the treatment of less than 2 lakh patients in US
Fiscal year (FY) Voucher fee ($)
then A tropical disease product application would be required
to fulfill the legal requirements like any other human drug 2011 4,582,000
application. Section 736 of the FD&C Act contains a complete 2012 5,280,000
description of the user fees of the human drug application.
2013 3,559,000
2. If it qualifies for orphan drug designation then No application
2014 2,325,000
user fee is required to be paid for the application. If the form
does not contain an indication other than a rare illness or 2015 2,562,000
disorder, it is subject to any exemption. For certain orphan- 2016 2,727,000
designated drugs referred to in section 736(k) of the FD&C Act,
2017 2,706,000
a waiver from annual drug product and establishment fees is
given. 2018 2,830,579
2019 2,457,140
Fees applicable for the application subjected to priority review
voucher: 2020 2,167,116
● The sum of the tropical disease priority review user fee for each The changes made in PRV Program since its inception:
fiscal year(FY) = The average cost incurred by FDA in the review
of a human drug application submitted for priority review in the Before:
previous fiscal year - the average cost incurred by FDA in the ● Restriction on no. of times the voucher should be transferred
review of a human drug application that is not subject to priority ● Notification to FDA must be given 365 days before
review in the previous fiscal year[12]. redeeming a PRV
● The fee is to be paid along with the application for which the After:
priority review is to be considered[1].
● The limitation on transfer of vouchers was removed.
● The priority review user fee is not waived off, exempted, reduced
● The alert to FDA must be given 90 days before redeeming
or refunded[1]. a priority review voucher.

Pharma Times - Vol. 54 - No. 11, November 2022 26

 The difference between Priority Review and Accelerated Limitations of the PRV Program:
Approval or fast track designation can be elaborated as: ● The drug applying for Priority Review must itself first earn a
Priority Review Designation[13].
Priority Review:
● This program may aim to boost R&D and innovation but it does
Eligibility criteria (The types of drugs qualify for the respective not guarantee the availability of the drugs to the patients of the
type of review)- LMICs.[17]
The drug provides increased safety or effectiveness of the ● It encourages innovation but fails to ensure the affordability of
treatment, diagnosis, or prevention of serious conditions when the drugs.[16]
compared to standard applications then it is subjected to priority ● Since the dugs already approved outside US are also eligible
review. The priority review shall not affect the period for which the for the PRV, this hampers the objective of encouraging
clinical trial is undertaken. innovation[18].
● There is absolutely no proof of re-investment of the voucher
Benefits- FDA shall allocate its resources and attention to the
money by the company in the development of another new
assessment of such applications which are expected to increase
tropical disease drug.
the safety and improve the treatment.
● The Congress may not further renew the PRV Program.
Action taken or decision made-06 months is the maximum ● There might certain drugs for which there might be market
time taken for the review. available and the patients who can afford to pay and thus in
Accelerated approval: such a condition the PRV may just end up as a bonus.
Eligibility criteria (The types of drugs qualify for the respective ● FDA does not promise the expedited review completion of the
priority review eligible drugs in 6 months.
type of review)-
● The uncertainty of winning the PRV discourages the investment.
If the drug is for grave and life-threatening conditions that
● The uncertainty in the value of the vouchers might make the
satisfy an unmet medical need which shows an effect either in the investors uninterested [10].
surrogate or immediate clinical endpoint then it shall be granted
accelerated approval. Critical aspects of PRV Program:
e.g. The drugs for AIDS and cancer In recent years, there has been an overall increase in the
number of priority review vouchers granted by the FDA. The
Benefits- The surrogate endpoint can be used as the basis increase in the number of companies holding the vouchers and
of approval for the drugs. The surrogate endpoint enables FDA to decrease in the reinvestment in Rand D has increased the number
approve the drug faster. of outstanding vouchers [3]. If there are more outstanding vouchers
the selling price of the voucher is bound to reduce since the emptor
Fast Track Designation can find an alternate seller to negotiate with[19,20]. The increasing
Eligibility criteria (The types of drugs qualify for the respective counts of available PRVs have affected the ability of the seller to
type of review)- extract maximum amount since the buyer can ask for settlement.
Therefore, the FDA can tighten the criteria of eligibility in order to
Such a designation accelerates the review of drugs to treat increase the voucher price which in turn will increase the innovative
serious diseases by filling an unmet medical need. Requested by research in marginal drugs.
the drug company anytime during the drug development.
Second, conducting clinical trials in the area of neglected
Benefits-The regularity of correspondence assures that issues tropical diseases is an arduous task since they are not an exception
are settled promptly, often resulting into sooner drug release and for comprehensive clinical trials. Third, according to.Fourth,
access by patients. Congress can ensure the affordability of the drugs by including the
pricing regulation as one of the eligibility criteria to award the PRV
Action taken or decision made- Days taken to make a decision: and ask the manufacturers to draft a plan related to affordability
60 days and accessibility.
Benefits of the PRV Program: Conclusion
● The PRV Program increases the innovation for targeted The PRV program was introduced by Congress in order to
diseases[15]. incentivize the development of tropical diseases. Since, a return
● It is also expected to complement other drug development on investment cannot be expected in case of diseases affecting a
initiatives [15]. limited population therefore, the companies can be influenced to
develop new drugs and therapies by philanthropy and government
● The list of diseases for the PRV Program can be updated by
financing. Later it was expanded to include rare pediatric diseases
the addition of not only new tropical diseases but also the
and the medical countermeasures. This program rewards the
ones for which there is no sufficient innovation possible due voucher which can be used to reduce the review time of some other
to insignificant markets and affects poor and marginalized drug of the same company or can be sold to another company. The
populations. continuous update of the list indicates that the U.S. Govt. is viewing
● The 4 month earlier access to the market is provided for the the program positively[17].
drug under priority review[16]. The Tropical Disease Priority Review program may have
● There can be unlimited transfer of PRV[1]. boosted the drug development initiatives but it has not been able

Pharma Times - Vol. 54 - No. 11, November 2022 27

to reduce the failure rate of these programs. The failure is not 2 p.]. Available from: https://jamanetwork.com/journals/jama/
very uncommon thing during the drug development phase but, fullarticle/2645091
since the award is not provided for the unsuccessful attempts, 11. Shortening the Review Clock: The Latest on Priority Review
the company may determine that the investment is not worth the Vouchers[Internet]. Camargo. C2020 - [cited 2020 Jan 01]. Available
potential prize[21]. The FDA is under no obligation to provide the from: https://camargopharma.com/resources/blog/shortening-review-
voucher but developers can receive signals from FDA regarding clock-latest-priority-review-vouchers
the eligibility of receiving them[9, 22]. The increase in the number 12. FDA. Fee for Using a Tropical Disease Priority Review Voucher in Fiscal
of outstanding vouchers rewarded is now bringing down the price Year 2020 [Internet]. Federal Register: The daily journal of the United
of the voucher during resale and according to Ridley, the price States Government 2019; 84:51601-03.
below $100 million does not incentivize the program[19, 20, 23]. Some 13. Accelerated approval. [Internet]. FDA, [updated 2018, cited 2019
reviewers have stated it as an unsustainable mechanism because Dec 04]. Available from: https://www.fda.gov/patients/fast-
it relies indirectly on the US patients paying[15.] This initiative can track-breakthrough-therapy-accelerated-approval-priority-review/
be replaced with better programs which will concentrate on the accelerated-approval
incentive program, especially for R & D and the conduction of
14. Fast Track. [Internet]. FDA, [updated 2018, cited 2019 Dec 04].
clinical trials[15]. The FDA has also warned that such programs
Available from: https://www.fda.gov/patients/fast-track-breakthrough-
could debilitate its ability to concentrate on other health priorities
therapy-accelerated-approval-priority-review/fast-track
due to limited resources[24].
15. Research Synthesis: Priority Review Vouchers. Danielle Navarro:
There are very few companies which will think of proceeding The Knowledge Network on Innovation and Access to Medicines.
for such a program due to the risks and challenges. The program [updated 2019 Feb; cited 2019 Dec 04]. Available from: https://www.
can be modified in a better way in order for it to balance the legal, knowledgeportalia.org/priority-review-vouchers
economical as well as social aspects of the society. 16. Ana Santos Rutschman .The Priority Review Voucher Program at the
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Pharma Times - Vol. 54 - No. 11, November 2022 28

 book review
include simple exercises
(e.g., granulation on extraction
of effervescent and estimation
products, of
plant based
herbal constituents of pharmaceutical significance.
products, Nutraceuticals, melt granulation techniques, and
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Identification
Title:
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The book on “Practical Pharmacognosy”
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is written by C. K. Kokate. The Author is highly experienced It is extremely useful book for students of pharmacy P.G.,
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g e t h ro u g hasPwell
ro d uasc tallL ipharmacy
fe C yc l e
are
Thisinis forefront globally
fifth revised and
edition. occupy
Book is wellthe highestwith
designed position
cover or non-pharmacy
management professionals who wish to understand
with
Page respect to its 222
and it contains acceptance and consumption.
pages. It consists The
of twelve chapters Pharmacognosy
• US FDA guidance well. on Continuous manufacturing and
development
and and eightscientists
Appendices. are always on the lookout for finding discussion thereof
better ways to produce OSD forms with higher efficiency. Reviewer
This book presents
Granulation the entire
of tablet dosageinformation
form is inonea very systematic,
such process Dr. Anandrao
• Role Shedge,
of excipients
practical and user friendly manner giving all
which requires detail study. The Editor, Dilip Parikh essential details
has MET -Institute ofPar
• Emerging Medical Sciences,
ticle engineering technologies and
in simple
made way for efforts
incredible easy understanding.
in compiling allAn the
effort is made of
advances to Vicecharacterisation
–President IPA –MSB, Mumbai.
granulation science from 50 authors and co-authors from • Dynamics of using various machinery and equipment
all over the globe and presented in a very lucid and simple
• Updated current research and development in granulation
language with examples and case studies. The efforts are
technology
commendable and deserve much appreciation especially

PHARMA TIMES
during this challenging Covid-19 pandemic time. I would
like to place my rich compliments to all the subject matter
experts for their value-added contribution.
The book is designed to give readers a comprehensive
knowledge in the area of latest developments in granulation
science. The inclusion of the over view of common
RENEWAL OF SUBSCRIPTIONobservations FOR THEbyYEARS regulatoryAHEAD
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technology of granulation
attempt to address new technologies and its related
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Pharma Times - Vol. 53 - No. 11, November 2021 30 Pharma Times - Vol. 54 - No. 11, November 2022 29
 PHARMA WITS AND LEISURE
- Raj Vaidya
PHARMA CROSSWORD 70
1 2 3 4 5
PHARMA MUMBO-JUMBO - 70
Unscramble each of the following 6 sets of letters to form
6 pharma related words. Then select the letters in the circles, and
use each letter once, to make another pharma related 14 – letter
word taking clue from the hint provided.
7

8
EATLR X X X X X
9
PHXYIOA X X X X X X X
10 CHPTEAI X X X X X X X
11 12 EYMMOR X X X X X X
13 RNIBA X X X X X
AAMDEG X X X X X X
CLUES
ACROSS Clue: Disorder of the part where the mind is
1. Waste product from muscle tissue breakdown. Tested to check kidney Master Word
function (10)
2. CA of a parallel circulatory system (8)
7. Seizures affecting a single area of the brain (7)
8. Single stranded genetic material. Helps in building amino acid chains
(1,1,1,1)
This Quiz is open to IPA members only.
9. Scale used for dosing of insulin [In reverse direction] (7) You need to send your completed entries, along with your name,
10. Evidence based guidelines used in UK (1,1,1,1) designation/affiliation, address, contact details, and IPA membership
11. Gram -ve bacterial genus – meningitis, gonorrhoea (9) number to [email protected]. You can complete the
quiz on this page itself & scan the page & mail it to us. Alternatively,
DOWN you can download the quiz from the IPA website at www.ipapharma.
1. The hormone that opposes actions of the PTH (10) org & send it across.
2. Machine that takes over functions of lungs and heart (1,1,1,1)
The first 3 correct entries (a correct entry is one in which both the
3. One of the hormones released by the smart control centre in the brain
(1,1,1) quizzes – crossword and unscramble – are all correct) would be
4. The roundworm phylum (8) declared winners of the quiz.
5. Clot getting stuck when travelling in blood stream (8)
7. Bone disease due to fast working osteoclasts (6)
Last date for receiving entries : December 30th 2022
11. Vector borne virus that can sinks platelet counts [last 2 of 6 letters] (2)
12. Main inhibitory neurotransmitter in CNS [1st 2 of 4 letters of the acronym]
(1,1,1,1) Read the January 2023 issue for the quiz results &
the names of the winners !!

pharma crossword - 69 PHARMA MUMBO JUMBO 69

Unscramble each of the following 6 sets of letters to form pharma related words. Then
1
P K 2
M 3
U S T 4
A R 5
D select the letters in the circles, and use each letter once, to make another pharma related
E 6
T R M O 13 – letter word taking clue from the hint provided.
7
R O E N T 8
G E N B WRHGTO X X X X X X GROWTH
N M G 9
I C U SEURUT X X X X X X UTERUS
10
I M P E 11
T I 12
G O T EIUSTS X X X X X X TISSUE
C O E M 13
F A PRSMAC X X X X X X CRAMPS
14
I P R A T R O 15
P M GIILNN X X X X X X LINING
O A A 16
A M I OIEDPR X X X X X X PERIOD
U 17
L A N C E T N Clue: Painful extra – uterine growth
18
S D Y 19
D Y E • Master word : ENDOMETRIOSIS

Pharma Times - Vol. 54 - No. 11, November 2022 30

IPA Hospital Pharmacy Division
FIP Digital Event on Pandemic Preparedness Pharmacy's
Global Response to the COVID-19 Pandemic
FIP organized digital event on pharmacists, nurses, other health care professionals and top
27th October 2022 on 'Pandemic officials of the Health and Family Welfare Department, Govt.
Preparedness Pharmacy’s Global of West Bengal participated in this conference. Dr. Subhrajyoti
Responses to the COVID-19 Bhowmik was the organizing Chairperson of this Medical Safety
Pandemic'. From India, Dr. Conference.
R.N. Gupta, Chairman, Hospital
Pharmacy Division and Vice
President, IPA was invited IPA Kerala State Branch
along with other panellist from Certificate Awarding Ceremony: Training program on Patient
different countries. The program Counseling
started by welcome speech by The IPA Kerala state branch successfully conducted training
Ms Lina Bader, FIP Lead for on Patient Counseling for 58 practicing pharmacists working
equity, Sustainability policy and in government and private pharmacies. On 9th October 2022, a
Development. Dr Catherine virtual certificate awarding ceremony was inaugurated by Dr. TK
Duggan CEO, FIP presented Ravi, Principal, College of Pharmacy, Sri Ramakrishna Institute
introductory speech. Ms. Nilhan of Paramedical Sciences, Coimbatore. Dr. Manjula Devi, Program
Uzman, FIP Lead for education Coordinator and Associate Professor of Pharmacy Practice
and Primary Healthcare policy presented her lecture. Mr. Daragh College of Pharmacy, Sri Ramakrishna Institute of Paramedical
Connolly, Chair of BPP, Ireland, also spoke on the occasion. Ms. Sciences, Coimbatore introduced the Chief guest. Dr. Rajasree RS,
Farah Aqqad, FIP, Regional Engagement, Support and Development Dean, Faculty of Pharmaceutical Sciences, KUHS and Professor
Manager invited and introduced speakers. Ms. Hala Sacre of CEO, of Pharmacy, College of Pharmaceutical Science, Govt. Medical
INSPECT, Lebnon, Ms. Mariet Eksteen of South Africa, Ms. Terasa College, Alappuzha was the Guest of Honor. Dr. P. Jayasekhar,
Almeida of Portugal, Prof. Sofia Segura, University of Costa Rica, Dr. President of IPA Kerala state branch in his prudential address
R.N. Gupta, IPA, Ms. Clare Fitzel of Irish Pharmacy Union, Ms. Jack congratulated the participants. Dr. John Joseph, Hon. Secretary
Sin Lim, Malaysia, Ms. Mary Ann Sant, President, Malta Chamber of IPA and Principal, Lisie College of Pharmacy, Kochi welcomed the
Pharmacists, and Ms. Leonor Soares, Portuguese Pharmaceutical gathering and Mrs. Manju CS, Program Manager and Associate
Society were the panellist. They presented their role in COVID-19. Professor of Pharmacy Practice, Govt. Medical College, Kozhikode
Ms Sherly Meilianti, FIP Data and Intelligence Specialist spoke gave an overview of 17 training modules and regulations. Dr. Suja
on 'Global survey on Pharmacy Response to Pandemic'. Ms Lina Abraham, Program Manager and Professor of Pharmacy Practice
Bader spoke on 'FIP Response to COVID-19', Ms Nour Eltahla, FIP at Nirmala College of Pharmacy, Muvattupuzha announced the
Projects Coordinator-Equity Sustainability policy And Development best performers of the training program. Ms. Binu Babu, Sr.
spoke on FIP Response also. Closing remarks was presented by Litty Rose Mathew, Sr. Merlin George, Ms. Vismaya P and Priya
CEO, FIP, Dr. Catherine Duggan. Lastly Vote of thanks was given Jacob were given certificates of merit and mementos. The
by Ms. Lina Bader. participants also shared their rich experiences in the training
session. Awarding winners of ‘The Dengue Prevention Day’
Poster competition was announced by Dr. Shamna MS program
IPA Bengal State Branch
coordinator and assistant professor of Pharmacy Practice, Govt.
Report on Medisafecon (Medical Safety Conference) Medical College, Kottayam. Ms. Shini Janardhanan bagged the 1st
IPA Bengal Branch along with Peerless hospital and several other prize in the professional category whereas Ms. Meha Joshy (St.
professional organizations organized Medisafecon (Medical Safety Joseph College of Pharmacy, Cherthala) got 1st prize in the student
Conference) on 16th September, 2022 at Altair Hotel, Salt lake category.  Ms. Anupama (NK Nirmala College of Health Science,
city, Kolkata. On behalf of IPA Bengal Branch, several members Chalakudy) and Ms.  Magha C (Govt. College of Pharmaceutical
participated in this conference. During the inaugural function, Science, Kannur) bagged 2 nd and 3rd prizes respectively. All
Mr. Prabir Banerjee, President, IPA Bengal Branch delivered were given cash awards and certificates of appreciation. Dr. CS
his lecture. Dr. S.C. Mandal, Vice President and Chairman of Satheesh Kumar, President, IPGA; Dr. PK Sreekumar, President,
Regulatory Affairs division, IPA National was one of the panelists Kerala Pharmacy Graduates’ Association; Mr. Jayaraj LR,
on the topic ‘Medication safety in Gastroenterology’. Dr. M.G. Secretary General, All Kerala Chemists and Druggists Association
Patel (U.K), on the topic ‘Medication safety in Oncology practices’; and Mr. Krishnadasan ER Chief Pharmacist Railway Sub Divisional
Dr. C.M. Hossain, on the topic ‘Medication safety in Elderly and Hospital, Shoranur offered felicitation. Mr. Shisi A, Treasurer
Domiciliary Care’ were fellow panelists. A good number of doctors, proposed a vote of thanks. 

Pharma Times - Vol. 54 - No. 11, November 2022 31

IPA Mangalore Local Branch
Three days National Seminar on ‘Research Methodology
and Biostatistics’

Telangana State Pharmacy Council, Telangana honored

Dr. Chennupati V. Suresh, Professor & HOD, Pharmaceutical
Analysis, Nalanda College of Pharmacy, Nalgonda, Telangana
with BEST PHARMACY TEACHER AWARD on 26th September,
2022 during ‘World Pharmacist Day’ celebrations at Nalanda
College of Pharmacy. Dr. Chennupati V. Suresh, was also
honoured with ADMIRABLE PROFESSOR AWARD-2022 on
National Seminar on ‘Research Methodology and Biostatistics’ 5th October, 2022 during ‘World Teacher’s Day’ celebrations on
was organized by Srinivas College of Pharmacy Mangalore in the basis of Dr. Suresh’s wide contribution in Pharmaceutical
Education and Research.
association with the Indian Pharmaceutical Association, DK
factored
District and
Local diagnostic
Branch, testing
Mangalore is included
on 13to th alert on incidences
October, 2022. Dr.
of sideRao
effects. The health ministry, the medical,Medical
pharmaceutical Advertisement
Advertisement Index
Index
Ravi S, Principal, Karnataka Ayurvedic College,
community,
Mangalore healthaddressedinsurance companies,
the delegates inand
the the IT industry
inaugural need
function Sr.
Sr. No.
No. Company Name
Company Name Pg.
Pg. No.
No.
to think of how this can be achieved.
by lighting the lamp and giving a talk on ‘Challenges and 1. Malaysian Rubber Council (MRC).................................... 2
Opportunities in Drug Research’. Dr. A. Shabaraya, Principal 1. Malaysian Rubber Council (MRC)..................................... 3
Acknowledgements 2. ACE .................................................................................. 11
and Director, Srinivas College of Pharmacy and President, IPA, 2. ACE...................................................................................32
The author acknowledges Dr. Michel Danino for providing 3. Ami Polymer .................................................................... 31
DK District Local Branch gave his presidential remarks. Guest
consent to cite his presentation and for his valuable suggestions. 3.
4. Ami Polymer.
Elmach ....................................................................40
Packages (India) Pvt. Ltd.....................20, 21, 40
of Honor, Prof. Shashidhar Kotian M, Research Director, Allied
Health Sciences and Nursing, Srinivas University, Mukka,
References 4. Elmach Packages (India) Pvt. Ltd...................... 22,23,44
1. Hammarsten
Mangalore gaveJF,aTattersall W, and Hammarsten
talk on ‘Sampling Techniques JE. Who
and discovered
Selection
smallpox vaccination? Edward Jenner or Benjamin Jesty?, Trans. Am.
of Statistical Methods’. Dr.
Clin. Climatol. Assoc. 1979; 90:44-55 Sathish S, Professor, Dept. of
Pharmacy Practice, Srinivas College of Pharmacy,
2. Acharya SK, Ghosh K, Kar A (Ed.), Saraswati – The River Par Excellence, Mangalore
gaveDecember
a talk on2020, The AsiaticProtocols’.
‘Research Society, 1 Park OnStreet, Kolkata 700016.
14 th October, 2022,
3.
Mrs.Sarkar A, Mukherjee
Shilpakala, AD, Bera MK,
Associate Das B, Juyal
Professor, N, Deshpande
Srinivas RD,
Institute
Shinde VS, Rao LS, Oxygen isotope in Archaeological Bioapatites
of from
Technology, Mangalore gave a talk on ‘Application
India: Implications to Climate Change and Decline of Bronze Age of
Biostatistics in Research’.
Harappan Civilization, Dr. Karunakar
Scientific Reports, 2016, Hegde, Professor and
6: 26555.
HoD,
4. Dept. of
Chatterjee Pharmacology,
Anirban, Ray Jyotiranjan,Srinivas
ShuklaCollege of Pharmacy,
Anil, & Pande Kanchan,
(2019), “On
Mangalore gave thea Existence
talk on ‘Roleof a Perennial River inAnimal
of Institutional the Harappan
Ethics
Heartland”, Scientific Reports, 2019, 9: 1722.
Committee (IAEC) and CPCSEA guidelines’ and
5. Michel Danino, Fabricating Evidence in Support of the Aryan Invasion
Dr. Kumara
Prasad S A,Theory,
Migration Professor
Paperand (to beHoD, Dept. presented
published) of Pharm.at Analysis,
National
Conference
Srinivas on Indian
College History: Emerging
of Pharmacy, Perspectives
Mangalore gaveorganized
a talk on by
Indian Council of Historical Research, New Delhi, March 5-7, 2018;
‘Analytical Instruments in Drug Research’.
Available From https: // www.academia.edu39599444/ Dr. Krishnananda
Kamath
6. Coppa K, et Professor and HoD,
al; Early Neolithic Dept.ofofDentistry.
Tradition Industrial Pharmacy,
Nature, 2006,
440:755–756.
Srinivas College of Pharmacy, Mangalore gave a talk on
7.‘How
(https://www.indianculture.gov.in/artefacts-museums/pashupati-seal)
to write dissertations’ and Dr. Monika Sadananda,
8. Jaiswal Yogini
Professor, S., Williams
Department of Leonard L., A glimpse
Biosciences, of Ayurveda
Mangalore – The
University
forgotten history and principles of Indian traditional medicine, Journal
gaveof Traditional and Complementary Medicine, 2017, 7(1):50-53 E.V.S
a talk on ‘Research Grants and Publications’. Dr.
Subrahmanyam,
9. Tipton CM, Sushruta Professor,
of India, AnSrinivas College
unrecognised of Pharmacy
contributor and
to the history
Viceof President, IPA, D.K.
exercise physiology. District
J Appl PhysiolLocal
2008,Branch, welcomed and
104: 1553-1556
10. Dwivedi S,the
introduced Singla S, Science
guests. Ms.ofRash
Exercise: Ancientand
Haleema IndianMs.Origin, Journal
Rashmitha
of the Associations of Physicians in India, 2014, 62:73
anchored the program. Mr. Dr. Krishnananda Kamath K,
11. Mondal S, Science of exercise: ancient Indian origin, The Journal of the
Associate Professor
Association proposed
of Physicians of India,the vote
2013, of thanks.
61(8): 560-562.Delegates
from pharmacy colleges of Karnataka and
12. (https://sanatansinhnaad.wordpress.com/2013/11/18/sushruta-the-Kerala attended
thefather-of-surgery/).
program.
13. Loukas M., Lanteri A., Ferrauiola, Tubbs R.S., Maharaja G., Shoja M.M.,
Yadav A., and Rao V.C., Anatomy in Ancient India: a focus on the Susruta
Samhita, J. Anat., 2010, 217:646-650
14. Saniotis Arthur, “Sushruta on Human Dissection as Pre-requisite to
surgery”, International Journal of Morphology, 2021, 39 (6):1787-1790 ATTENTION SUBSCRIBERS
15. Bhattacharya S., “Sushrutha - our proud heritage”. Indian J. Plast.
Pharma
Pharma
Pharma Times
Times
Times
Surg., 2009,
--- Vol.
Vol. 54
51 --- No.
Vol. 53
42(2):223-5,.
No. 11,
No. 11, November
11 -November
November2021 2022
2019 32 3232
16. Dubashi Siddharth P, Aishwarya Avnish, Sushruta:Foundation for RENEWAL OF SUBSCRIPTION
 WORLD
World
PHARMACISTS
PHArMAcISTS welcome address. He informed about the objectives of WPD and
well soon ‘card to the patients of J.N.M. Medical College and

DAY
dAy
also suggested pharmacists carry out pharmacy practices to get
Hospital, Kalyani. Mr Pradip Mallick, Treasurer proposed Vote of
confidence in the mass. Dr. Rohana Binati Hasan, Dy. Director,
Thanks. Representatives Alok Dasgupta and Dr Tapas Roychowdhury
Health, Government of Malaysia, was the Guest of Honor. She
of Bengal Branch visited S.S.K.M. Hospital, N.R.S.Medical College
talked on ‘Pharmacy Practices in Malaysia: Perspective and
and Hospital, Kolkata, National Medical College and Hospital
Actions’. Dr Suresh Saravdekar, Vice Chairman, Hospital Pharmacy
Bihar State
IPA Bengal StateBranch
Branch Kolkata. Dr M.P.Rana E.C members of IPA Bengal State Branch
IPA Bengal State Branch Division, Indian Pharmaceutical Association and Dy. Director (Retd),
On the occasion of the World Pharmacist Day, Indian delivered a lecture on this occasion at a seminar organised by
Government of Maharashtra, presented the keynote address.
Pharmaceutical Association Bihar State Branch organised R. P. Pharmacists Association, West Bengal at National Medical College
He discussed and compared the pharmacy services abroad and
Singh Inter College Elocution competition in the Library of Shree and Hospital. Other two representatives of the branch were Aritra
that of India and suggested that we have to evolve our pharmacy
Baidyanath Ayurved Bhawan Pvt Ltd, Patna. The program was Chaterjee and Dibya Das visited Apollo Hospital and distributed
services and have to focus on patients as a centre of services. He
inaugurated by the Sri. Pramod Sharma, Director of Shree Baidyanath ‘Get well soon‘ card to the patients. Two representatives Madhab
also suggested modifying the pharmacy syllabus accordingly and
Ayurved Bhawan Pvt. Ltd. and started with a welcome speech by Sri. Banerjee and Aritra Chaterjee attended a seminar organised by
including the hospital services and pharmacy colleges attached
Saniiv Rai, Branch President. Sri Mukesh Kumar informed that the Progressive Pharmacists Association, West Bengal at Swyastha
to the medical colleges, like in the rest of the world.  The Chief
PIL against State Council regarding fake pharmacist registration and Bhawan, Salt Lake. ‘Get well soon’ cards were also distributed to
Guest, Dr. Yulia presented her guidance to all pharmacists on the
implementation different hospitals of West Bengal. Durgapur chapter of IPA Bengal
occasion
Patna. TheofPharmacists,
WPD and praised pharmacy the students
vital services of pharmacists
On the occasion of World Pharmacists Day, IPA Bengal Branch State Branch also celebrated the day at DSPand other
Hospital, dignitaries
Durgapur.
organised a seminar at the IPA auditoriumo fonP P R ` 1year’s
this 5 in in the healthcare
present maintained of one
people.
minute Shesilence
also advised
for those pharmacists
pharmacists to
theme, ‘Pharmacy United in action for a Healthier World’. Prof. Bihar is in the keep
who acquainted
had lost theirwith
livesthe latestCovid-19
during technology and advancement
pandemic. The program in
IPA Delhi State Branch
(Dr.) Pranabesh Chakraborty, UGC Professor
Like previous years, this year also World Pharmacists Day was final
(Adjunct) stage.and R.
Dr. pharmacy
started to abewelcome
with utilized during
speech pharmacy
by the branchpractices. Dr.
president M.P.
Sri.Chopra,
Sanjiv
Bandyopadhyay, Student Forum of IPA Delhi State Branch organized an auspicious
Subhrajyotithroughout
celebrated Bhowmik, Bengal Clinicalby Director,
organising Peerless
seminars, Hospital ‘Get andwell Secretary
and Sri. R.ofBandyopadhyay,
the branch and hospital pharmacy
Hon. Secretary division
of the proposed
branch. Chief
event on World pharmacist day, 25th September, 2019, together
B.K. Roy
soon’ gave
card their viewstoalong
distribution patientswith Mr. Prabir Hon.
of different Kumar Secretar
hospitalsBanerjee, andy a Vote Dr.
Guest of Thanks. 
Rakesh Kumar Singh in his speech shared his research
contributing to safe and rational use of medicines. This time
President
badge of IPA Bengal
distribution to theBranch delivering
Pharmacists andthe of the
welcomestudents.
Pharmacy Branch,
address. experience in nanotechnology particularly in the field of Ayurved.
elaborated the DIPSAR, DPSRU and JAMIA HAMDARD pharmacy students visited
Dr.
On S.C.
thisMandal,
occasion Vice President
several andseminars
virtual Chairperson were of the Regulatory
organised by Sir. Pramod Sharma, Managing Director Shree Baidyanath Ayurved
affairs division
different Pharmacy of IPA National
colleges was the
of West moderator
Bengal and othero bofj ethe
c t iseminar.
ves of
professional Bhawan Pvt and Sri.Branch
Kumar Ajay, vice president of the branch and
celebrating Pharmacist IPA Kerala State
Badges to the
organisations. BengalDay
pharmacists
IPA throughout
along
Branch with ‘get
organised thewell acountry.
soon’ Dr.
webinar on(Prof)
cards 25toth member of PCI, New-Delhi elaborated about the Gazette Education
Dineshwar
the patients2021
September, Prasad,
of differentPrincipal
and invited Govt.
hospitals Ayurved
Mrs. throughout
Manjiri Gharat,College & Hospitals,
WestVice-President
Bengal were Regulations, 2020 for Diploma course in Pharmacy. Dr. L.K.
Patna
and advised
distributed.
Chairperson theofpharmacy
A seminar students
was organised
Community Pharmacy tobydevelop
Brainware
Division, communication
IPAuniversity
as chief Chaudhary past President, Sri. Suresh Pandey, Director M/s Samrat
skillsProf.
with
speaker which theare
onRabichandiran,
theme. veryMrs.important
Director
Gharat nicely to perform
NIPER, Kolkatatheir
deliberated on duties
and Mr. theme
the Prabir as Laboratories also spoke on the occasion. R. P. Singh Inter College
healthcare
Banerjee,
of this year’s provider.
President, He
IPA also
World PharmacistsBengal informed
Branch
Day. Dr.that a National
deliberated
Rabichandiran, onSeminar
theDirector,
theme. on Elocution Competition 2021 was organised and the winners were
standardization
Prof. B.B. Barik,was
NIPER-Kolkata on Herbominerals
Principal
the Guest of the will beon
ofPharmacy
Honour held at occasion.
Department
this Patna on 25
delivered
th
Prabir to 1st Prize - VISHAY KAUSHIK, Muzaffarpur Institute of Technology,
26
the
th
December,
welcome 2019
address. and appealed
Another function
Banerjee, President, IPA Bengal Branch welcomed the guests pharmacist
was and
organised pharmacy
by the Muzaffarpur, 2nd Prize - JAYA SINGH, Govt Pharmacy Institute Patna
students
Pharmacist
and to members
delivered take
an part ofinthe
theIPA
introductory seminar.
Bengal Dr.
speech. Dr. L.S.C.
Branch K.atMandal
Chaudhary, wasPast
D.S.P. Hospital, the and Gulistan Parween of Govt Pharmacy Institute Patna.
President Pharmacists
of IPA Bihar, 130 pharmacies all across Delhi NCR on 25th September, 2019. It
Durgapur.
moderator and Aritra ofSri.
Chaterjee Kumar
Ramkrishna
was the Ajay, Asst. Seva
Mission
coordinator Professor,
of thePratisthan,Govt.
webinar. was an awareness campaign to the pharmacies to celebrate and
Pharmacy
Kolkata
On also
the very Institute,
next dayPatna
observed and
i.e.World
on others
26Pharmacists
th also spoke
September, Day
2021 ontheir
in atheteam occasion.
hospital.
of IPA
To recognize the contribution of pharmacists, particularly in motivate the pharmacists and make them realize their importance
Pharmacist Association, West Bengal organised
Bengal Branch went to Naora Ramakrishna Math for distribution a seminar at NRS IPA Kerala State Branch
Hospital and Community pharmacy, in healthcare system and to provide information regarding
Medical
of College
dress materials and Hospital
to the poor basedPharmacist
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Parmanand Singh & Sri. Binod Kumar. The winners of R. P. Singh which is a prevailing issue in India.
was
Mr. presentBanerjee,
Prabir during the inauguralIPA-Bengal
President, function. Eminent BranchGupta, Pharmacist
joinedGovt. the on “Pharmacy: Trusted for your Health” on 25th September 2021
Inter
Dr. R.S.College
Thakur, Elocution
Former competition
Secretary of were
PCI and Suruchi
Dr. R.N. Gupta, Vice to commemorate the World Pharmacists Day. The function was
different webinars, as the
st speaker, organised by various Pharmacy IPA Jharkhand
Pharmacyand
President
colleges
Institute, 1 Prize;
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Minister for Health & Women and Child
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nd Department of Pharmaceutical
Prize
spoke and
on Vishay
this Kaushik,
occasion. 3rd Prize.
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Sri.
100 Sanjay
pharmacists Kumar JIS
World Pharmacists
Development, Smt. Veena Day was celebrated
George who by gaveIndian Pharmaceutical
a message in the
University,
concludedBharat the Technology,
celebration by Uluberia,
deliveringin BCDA
athese
Vote College
of Thanks.of Pharmacy
throughout
and AHS, Barasat, West Bengal
Schoolparticipated
of Pharmacy, Technoprogrammes
India University, and Association
World Pharmacist
inaugural Jharkhand
function. Day The State
Celebration
Chief Branch
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Amrita
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IPA Bengal State Branch
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his on 24
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August,
address, 2022 heHead,
at Pharmacy
Amriteshwari
focused on the
IPA Bengal Branch celebrated the World pharmacists day gaveAmrita
Hall, the welcome
contribution Hospital, address.
of pharmacistsKochi. Dr. inDr. B. N.
Sabitha
drug Sinha,
M. Vice President,
(Principal,
manufacturing Amrita
and School
research. IPA
Barasat. th Dr. Jayanta Chaudhury joined the webinar organised by
on 25 September, 2019 with different activities. On this occasion
IPA
Eminent– Jharkhand
college State Branchtechnology as the guest speaker Jharkhand
of
Dr.Pharmacy) branch
P. Jayasekhar,deliveredspoke theon
President, the
IPAtheme
welcome of state
address.
Kerala World Pharmacists
Mr.branch
M.P. George
welcomed Day.
(Vice
IPA Bengal StateofBranch
pharmaceutical
published a ‘get well soon‘ card and which Dr. R.N.
President,
the Gupta,
gathering. HePresident
IPA Kerala saidState of
thatBranch IPA,&Jharkhand
Kerala Retd.used
state Drugsto State Branch
Controller,
procure also
Kerala)
most of
and Dr. S.C. Mandal
were distributed to the joined
World the
patients webinar
Pharmacists
of different asDay the guest
was
hospitals speaker
celebrated
of West
organised by Bharat Technology. Mr. Dibya Das attended various spoke
delivered
the on the
thetheme
medicines fromofother
presidential day, address
"Safe
statesand andbyEffective
throwing Medicine
the government light onfor theAll".
promoted He
roles
by IPA, Jharkhand
Bengal. Dr Tulsi Chakraborty, former President and Secretary State branch in
of
hospitals for distribution of ‘Get well
collaboration soon’withcards
the and
Hospital badges. PharmacyWorld aspoke
and about the to
responsibilities
Pharma Park duties
of aof pharmacists,
pharmacist.
manufacture TheGMP,
medicines program role medical
and of pharmacist
was inaugurated
devices in
IPA Bengal State Branch, delivered a lecture on ‘Safe and effective patient
by
in counselling
the Chief
state. Guest, and Pharmacy
Honorable
To boost Justice Practice
DevanRegulations,
education Ramachandran
and research, 2015. (HighMr
the
Pharmacists
medicines forDay all’.was
An also celebrated
Division
audio-visual IPAbyonthe
of programme 25Durgapur
th
September
was presented chapter2022. of
on
IPA Bengal Branch. On the occasion of World Pharmacists Kuldeep
Court
central Singh, aHe
of Kerala).
governments wholesale
shallPharmacist
emphasized was promised
the important
establish the the Guest
role of Honour.
of pharmacists
“National
Ms. Trishna Yulia, Vice ‘FIRST AID' byDay,
President, St JohnIPA
FIP, Dr.the
in M Phealthcare
Institute Chopra, Secretary
team and
for Pharmaceutical of Branch,
remarked
Education coordinated
that
andtheResearchthe program
salient service and
(NIPER)” of
Bengal Branch also organised Hospitalposter design competition
Pharmacy Section
Ambulance wasand essay
theIndia.
Chief
writing competition among the students of Pharmacy colleges and proposed
pharmacists
in Kerala at thethe
isVote
not of Thanks.
noted
earliest. by the
Dr. public
Suresh or policymakers.
Madhavan He urged
Dean, University
Guest. A message on the occasion of
President of WPDIPA the clinical pharmacy service of of Pharmacy,
Pharm. D. US graduates
Pharmacy professionals was of West Bengal. of North Texas System College was the would
Guest
sent by Dr. Rao V.S.V. Bengal State Branch
Vadlamudi, Ex- surely
of Honoursupportand doctors
keynoteand reduce
speaker. Hemedication-related
gave a presentation issues
about in
President, Commonwealth P r a b i rPharmacists
Banerjee healthcare.
the pharmaceuticalDr. Col. Vishal Marwa provided
care service (Principal,byAmrita School of
the community
Association, Professional i n a u g uSecretary,
rated a Medicine)
pharmacists conveyed
in the US. theDr.WPD message.
Padmaja Dr. John Joseph
V, President Kerala(Secretary,
Pharmacy
IPA – Bihar State Branch
SEARPharm and Immediate seminar Pastorganised
Presidentth IPA Kerala State
Graduates Branch)
Association announced
presided over Pharma
the function Excellence Awards to
and emphasized
IPA Bihar State Branch celebrated World Pharmacist b y I n sDay t i t uont e 25o f
of the Indian Pharmaceutical Association honour
the need veterans in different
for academia- fields ofinteraction
industry the pharmacy for profession.
better research Prof.
September 2021 in the Library of Shree Baidyanath Pharmacy, Ayurved
Kalyani
which was readout by  Mr. Fahad Uddin, A.K. Chandrasekharan
outputs. (Former Director,
Dr. CS SatheeshKumar, CollegePast
Immediate- of Pharmaceutical
President IPA
Bhawan Pvt Ltd, Patna. The program was inaugurated f o l l Dr.o wR.N. e by lamp
dGupta, by
coordinator of the program. Sciences,
Kerala state Thiruvananthapuram),
and Sri. KJ John, Drug C.I. Jolly (Retd.
controller Prof., KMK
of Kerala statecollege
spoke
lighting by the Chief Guest Dr. Rakesh Kumar distributionSingh, ofHead- ‘Get
President of the branch presented the of
on pharmacy,
the occasion Bombay
about the andthemeResearch Director
of World Amala Research
Pharmacists Day. Dr.
Academic Nanotechnology Center, Aryabhatta Knowledge University

Pharma
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Pharma -- Vol.
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Times Vol. 54
51 -53 -- No.
No. No. 11,
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2019 33
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Centre, Thrissur), Dr. Muhammed Majeed (Founder and chairman behalf of IPA-MSB. The honorable Chief Guest, Mr. Mahesh Zagade,
M/s Sami-Sabinsa group, Bangalore), Mr. NS Alexander (Retd. Guest Of Honor, Mr. Subodh Priolkar, Guests - Dr. Abha Doshi, Dr.
Deputy Drugs Controller, Kerala) and Mrs. Annakutty M.J. (Retd. S. D. Bhosale, Dr. M. S. Gadge, Dr. K. N. Gujar, Mr. S. D. Jog, Ms.
Pharmacist) were honoured by the Pharma Excellence Award Sheeja Koliyote, Ms. Aushima Dasari, Ms. Vaishali Malvankar,
by Hon. Justice Devan Ramachandran for their contributions to Ms. Sushma Gokhale, and Mrs. Swati Priolkar was welcomed and
education, research, industry, regulatory and pharmacy practice felicitated. Mr. Mahesh Zagade, in his speech, emphasized the
respectively. Mr. P.K. Harikumar (Former Works manager, Kerala uniqueness and importance of a pharmacist in society and the
state Drugs & Pharmaceuticals Ltd, Alappuzha) Mr. David Joseph need to recognize the pharmacist’s effort towards the medical field,
(Director, Variety Fling Pharmaceuticals Pvt Ltd, Shornur) and Sri. future aspects and the current world statistics. Mr. Subodh Priolkar,
M.R. Pradeep (Deputy Drugs Controller, Kerala State) introduced delivered his speech on the importance of the pharmacy profession,
the awardees and highlighted their contributions to the profession generic drugs and pharmaceutical goals. The Chief Guest and
and society. Later, Dr. C.I. Jolly and Mr. N.S. Alexander addressed the Guest of Honour were presented with the momento for their
the gathering and shared their experiences and inspired the young contribution towards the pharmacy profession. Dr. Tabassum Khan
pharmacists. Mr. K.R. Dinesh Kumar (Member, Pharmacy Council of (HOD of Pharmaceutical Chemistry and Quality Assurance at Dr,
India, New Delhi) and Dr. Muhammed Hisham (Clinical Pharmacist, Bhanuben Nanavati College of Pharmacy, Mumbai), Dr. Paraag
Cleveland Clinic, Abu Dhabi) delivered the felicitations. Variety of Gide, (Principal of Dr. L. H. Hiranandani College of Pharmacy,
competitions for the students from 20th to 22nd September, 2022 Thane), Dr. Mohan Kale, (Principal of Konkan Gyanpeeth Rahul
were held like the debate competition, Pharmatoons (a cartoon Dharkar College of Pharmacy and Research, Kalyan) and Dr.
drawing competition), concept presentation competition and Swati Patil (Associate Professor at Principal K. M. Kundnani
elocution were awarded certificates and prizes. Mr. M.P. George College of Pharmacy, Mumbai) were felicitated with the Pharmacy
and Dr. Sabitha M. presented the token of gratitude to the chief Samman Award. The Star Hospital Pharmacist awardees were
guest, Hon. Justice Devan Ramachandran. Mr. M.P. George and Dr. Mrs. Hemangi Joshi (Manager Medicine at Haffkine Bio-Pharma
John Joseph presented a memento to Amrita School of Pharmacy at Procurement Cell), Mr. Sheetal Chandan (Hospital Pharmacist
for their excellent participation in World Pharmacist Day 2022. Dr. at KEM Hospital). The Star Community Pharmacists were Mr.
Sabitha M. and Department heads of ASP presented mementoes Vivek Shinde (Community pharmacist at Kalamboli), Mr. Swapnil
to dignitaries; Dr. John Joseph, Mr. M.P. George, Dr David Joseph, Jagdale (Community Pharmacist at Worli), Mr. Mahendra Rajpurohit
Mr. M.P. Pradeep, Mr. P.K. Harikumar, Dr. Muhammad Hisham, (Community Pharmacist at Parel) and Mr. Umesh Tiwari (Community
Mr. K.R. Dinesh Kumar. The program was concluded with a Vote Pharmacist at Panvel). Dr. Tabassum Khan, on behalf of Pharmacy
of Thanks delivered by Mr. Sachin G Nair, President, IPA-SF Amrita Samman awardees, delivered her speech while Dr. K.N. Gujar also
Student Chapter. shared his thoughts on this occasion. The event concluded with
a Vote of Thanks by Mr. Pravin Tak, Chairperson, IPA-MSB-SF. Dr.
Abha Doshi (Principal of MET Institute of Pharmacy, Bandra) also
IPA Maharashtra State Branch spoke about the importance of the day and appreciated IPA-MSB-
SF and MET Student Council for organizing the event. The hosts
for the event were Mr. Kashif Ali Shaikh (Joint Pharmacy Education
Officer, IPA-MSB-SF), Ms. Anupama Nair (Joint Public Health Officer,
IPA-MSB-SF) while the presentation was presented by Ms. Khushee
Jaiswal (Cell member, Pharmacy Education Office, IPA-MSB-SF).

IPA Mangalore Local Branch

On 25th September, 2022, the IPA-MB-SF in association with MET

Institute of Pharmacy, Bandra hosted an offline celebration in honour
of World Pharmacists’ Day. The event was held at MET Institute
of Pharmacy, Bandra. International Pharmaceutical Federation is
a global federation of national associations of pharmacists and
pharmaceutical scientists with a mission to support global health Indian Pharmaceutical Association, Dakshina Kannada District
by enabling the advancement of pharmaceutical practice, sciences Local Branch, Mangalore in association with Srinivas College
and education. Ms. Sakshi Upadhyay, Associate Editorial Officer for of Pharmacy Mangalore Celebrated World Pharmacist Day with
IPA-MSB-SF, recited Saraswati Vandana followed by the introduction the theme ‘Pharmacy United in Action for a Healthier World’ &
of IPA-MSB-SF. A brief video clip underlining the importance of the National Pharmacy Week 2022, with the theme, ‘Pharmacist:
day was shown. This was followed by the introduction of the IPA-MSB Frontline Health Professionals’ at Valachil Campus from 26th to
dignitary Dr. N. Sivaprasad, Director of the Board of Radiation and 30th September, 2022. On the first day of the event, Mr. Pramod
Isotope Technology (BRIT), and he gave the welcome speech on Hegde, Founder & Managing Director, Med Organics India Pvt. Ltd.,

Pharma Times - Vol. 54 - No. 11, November 2022 34

Baikampady, inaugurated the function. The Chief Guest, Shri. T.P. IPA Narsapur Local Branch
Sujith, Deputy Drugs Controller, Mangalore addressed the students
regarding the contribution of pharmacists in healthcare sector.
Dr. CA. A. Raghavendra Rao, Chancellor, Srinivas University &
President, A. Shama Rao Foundation, Mangalore in his presidential
remarks remembered the services rendered by pharmacists during
the COVID-19 pandemic and blessed all young pharmacists to serve
actively. Guests of Honour, Smt. A. Vijayalakshmi R. Rao, Member,
Board of Governors, Srinivas University, Mangalore. Prof. Er. Smt.
A. Mitra S. Rao, Member, Board of Governors, Srinivas University
and Secretary, A. Shama Rao Foundation, Mangalore, Sri. B.N.
Babu, Assistant Drugs Controller, Mangalore discussed the role of
Pharmacists and Sri. Uday Kishore P., Assistant Drugs Controller,
Mangalore advised the students about the number of departments
in the pharmacy sector that one can serve. Sri. Gurucharan Rao,
Secretary, South Canara District Chemist and Druggist Association, World Pharmacist Day, 2022, based on the theme ‘Pharmacy united
Mangalore; Sri. Panduranga Rao, Senior Pharmacist and Sri Ashok in action for a healthier world’ was celebrated on 26th September,
Rao, Rao & Rao Associates were present during the programme. Sri. 2022 organised by IPA Narsapur local Branch in association
B. Mohandas Gowda, Senior Pharmacist, Shiva Ganesh Medicals, with Vishnu Institute of Pharmaceutical Education and Research
(VIPER). VIPER organised many programmes like elocution, essay
Kokkada was felicitated in recognition of his services in community
writing, art and craft competitions including a blood donation
pharmacy. Dr. A.R. Shabaraya, programme convenor of National
camp and a pharmacist awareness rally in coordination with
Pharmacy Week 2022, President, IPA, Mangalore and Principal,
Narsapur Chemist and Druggist association, Pulla Reddy Institute
Srinivas College of Pharmacy, Valachil, Mangalore read out the of Pharmaceutical Sciences (PRIP) and (GIPS) Gland Institute of
citation of Sri. B. Mohandas Gowda. Dr. E.V.S. Subrahmanyam, Pharmaceutical Sciences (GIPS). During the inauguration, Dr. Alluri
Professor & Vice President, IPA, Mangalore highlighted the Ramesh President, IPA Narsapur Local Branch (Principal of VIPER),
significance of National Pharmacy Week and welcomed the guests. Dr. VVS Rajendra Prasad (Vice-principal), Mr. Ahmed Syed (Assistant
Ms. Sulalat and Mr. Mohammad Bilal anchored the programme and professor of GIPS), Rajashekar Perusomula, secretary, IPA Narsapur
Mr. Viresh K. Chandur proposed a Vote of Thanks. branch welcomed the participants and addressed the importance
of the role of the pharmacist in healthcare. All the participants
Drug Abuse Awareness Pharma Rally from various institutions actively participated in the essay writing
competition and elocution competions, which were successfully
hosted and conducted under the guidance of organisers and student
coordinators. During the art and craft competition, the students
projected their innovative ideas based on this year’s theme. On the
occasion of Pharmacist Day celebrations, a blood donation camp
was organised. A Pharmacist Awareness Rally in coordination with
the Narsapur Chemist & Druggist association, Pulla Reddy Institute
of Pharmaceutical Sciences (PRIP) and (GIPS) Gland Institute of
Pharmaceutical Sciences (GIPS) was organised where the students
from various colleges participated to create social awareness among
people about pharmacist and their role in the society. The event
was successfully hosted and conducted under the guidance of Dr.
Drug Abuse Awareness Pharma Rally was organised on 26th Ramesh Alluri, President of IPA Narsapur Branch, coordinated by Mr.
September, 2022 as a part of National Pharmacy Week 2022 Rajashekar Perusomula, Secretary, IPA Narsapur Branch.
organised by Indian Pharmaceutical Association, Dakshina
Kannada District Local Branch, Mangalore in association with
Shree Dev Bhoomi Institute of Education, Science and
Srinivas College of Pharmacy Mangalore. The rally was flagged
off by Sri. B. Mohandas Gowda, Senior Pharmacist, Shiva Ganesh
Technology, Dehradun
Medicals, Kokkada. Mr. Pramod Hegde, Founder & Managing
Director, Med Organics India Pvt. Ltd., Baikampady was present
during the rally. Dr. A.R. Shabaraya, Programme convenor of
National Pharmacy Week 2022, President, IPA, Mangalore and
Principal, Srinivas College of Pharmacy, Valachil, Mangalore and
Dr. E.V.S. Subrahmanyam, Professor, Srinivas College of Pharmacy
& Vice President, Indian Pharmaceutical Association, Dakshina
Kannada District, Local Branch, Mangalore and faculty members
were present during the rally. More than 600 students participated
in the rally by displaying placards with slogans against drug abuse
and distributing leaflets to the public to bring awareness.

Pharma Times - Vol. 54 - No. 11, November 2022 35

Shree Dev Bhoomi Institute of Education, Science and Technology, for pharmacy teachers. Dr. Abhijeet Ojha (Principal, Six Sigma
Dehradun celebrated World Pharmacist Day, 2022 on the Institute, Rudrapur and Vice-president of APTI, Uttarakhand state) in
theme ‘Pharmacy United in action for a healthier world’ with the his speech motivated the students for social works and to cultivate
association of Indian Pharmaceutical Association (IPA), Uttarakhand the traditional culture with essential technologies which could be
state, Association of Pharmaceutical Teacher Association (APTI), a natural instrument for all of the citizens of the world. Dr. Satish
Uttarakhand state and Red Cross Society, Dehradun on 25th Puttachari (Director, Technical Services, Jubilant Generic Ltd,
September, 2022. Dr. H.R. Chitme (Professor, Faculty of Pharmacy, Bhagwanpur, Haridwar) presented a presentation on this year’s
DIT University and President of IPA Uttarakhand state), in his theme and emphasized the role of pharmacists in healthcare. Mr.
inauguration speech, pointed out the success of pharmacists Anil Verma (Chairman, Youth Red Cross Committee, Indian Red
during COVID-19. Dr. Rajeev Kumar Sharma (Associate Professor, Cross Society, Dehradun) focussed to save every life through blood
Faculty of Pharmacy, DIT University and President of APTI donation. A Blood Donation Camp was organised and about 80
Uttarakhand state) expressed gratitude for being elected as the faculties, as well as students, participated in it. The programme
President of the Association of Pharmaceutical Teacher association was concluded with the Vote of Thanks by Mrs. Rita Saini (Associate
(APTI), Uttarakhand state and pointed out his aims and many plans Professor & Co-ordinator of the event).

Pharma Times - Vol. 54 - No. 11, November 2022 36

 Treatment for: Hepatocellular Carcinoma
Imjudo (tremelimumab-actl) is a cytotoxic T-lymphocyte-associated
antigen 4 (CTLA-4) blocking antibody indicated in combination
with durvalumab (Imfinzi) for the treatment of adult patients with
unresectable hepatocellular carcinoma (uHCC).
DRUG APPROVALS
www.drugs.com
DRUG APPROVALS
Rebyota (fecal microbiota, live-jslm) Suspension for Rectal Use
Lupin gets USFDA nod for generic oral contraceptive pill
- formerly RBX2660
www.economictimes.indiatimes.com; 4th November, 2022
Company: Ferring Pharmaceuticals Inc.
Drug maker Lupin has received approval from the US health
Date of Approval: November 30, 2022
regulator to market Drospirenone tablets, used to prevent
Treatment for: Prevention of Recurrent Clostridioides difficile pregnancy, in the American market. The company has received
Infection tentative approval from the US Food and Drug Administration (FDA)
Rebyota (fecal microbiota, live-jslm) is a microbiota-based live for its abbreviated new drug application (ANDA), Drospirenone
biotherapeutic indicated for the prevention of recurrence of Tablets in 4 mg strength. The company’s product is the generic
Clostridioides difficile infection (CDI) in individuals 18 years of age equivalent of Exeltis USA Inc’s Slynd tablets.
and older, following antibiotic treatment for recurrent CDI. US FDA approves first drug that can delay onset of type 1
Hemgenix (etranacogene dezaparvovec-drlb) Suspension for diabetes
Intravenous Infusion www.pharmabiz.com; 19th November, 2022
Company: CSL Behring The US Food and Drug Administration has approved Tzield
Date of Approval: November 22, 2022 (teplizumab-mzwv) injection to delay the onset of stage 3 type 1
Treatment for: Hemophilia B diabetes in adults and pediatric patients 8 years and older who
Hemgenix (etranacogene dezaparvovec-drlb) is an adeno- currently have stage 2 type 1 diabetes. Type 1 diabetes is a disease
associated virus vector-based gene therapy indicated for the that occurs when the immune system attacks and destroys the
treatment of adults with hemophilia B. cells that make insulin. People with a type 1 diabetes diagnosis
Tzield (Teplizumab-mzwv) have increased glucose that requires insulin shots (or wearing an
insulin pump) to survive and must check their blood sugar levels
Company: Provention Bio, Inc.
regularly throughout the day. Tzield binds to certain immune system
Date of Approval: November 17, 2022 cells and delays progression to stage 3 type 1 diabetes. Tzield may
Treatment for: Prevention of Type 1 Diabetes deactivate the immune cells that attack insulin-producing cells,
Tzield (teplizumab-mzwv) is a CD3-directed antibody indicated to while increasing the proportion of cells that help moderate the
delay the onset of Stage 3 type 1 diabetes (T1D) in adults and immune response. Tzield is administered by intravenous infusion
pediatric patients aged 8 years and older with Stage 2 T1D. once daily for 14 consecutive days.
Elahere (Mirvetuximab soravtansine-gynx) Injection Eugia Pharma receives US FDA nod for Amphotericin B Liposome
Injection
Company: ImmunoGen, Inc.
www.expresspharma.com; 18th November, 2022
Date of Approval: November 14, 2022
Aurobindo Pharma’s subsidiary Eugia Pharma Specialities recently
Treatment for: Ovarian Cancer
received final approval from the US Food & Drug Administration
Elahere (mirvetuximab soravtansine-gynx) is a folate receptor (USFDA) for Amphotericin B Liposome for Injection, 50 mg. The
alpha (FRα)-directed antibody and microtubule inhibitor conjugate product is bioequivalent and therapeutically equivalent to the
indicated for the treatment of adult patients with FRα positive, reference listed drug (RLD), AmBisome Liposome for Injection,
platinum-resistant epithelial ovarian, fallopian tube, or primary 50 mg/vial, of Astellas Pharma US. Amphotericin B Liposome
peritoneal cancer, who have received one to three prior systemic for Injection is indicated as empirical therapy for presumed
treatment regimens. fungal infection in febrile, neutropenic patients, treatment of
Tecvayli (Teclistamab-cqyv) Injection cryptococcal meningitis in HIV-infected patients, treatment
Company: Janssen Pharmaceuticals, Inc. of patients with Aspergillus species, Candida species and/
or  Cryptococcus species infections refractory to amphotericin B
Date of Approval: October 25, 2022
deoxycholate,or in patients where renal impairment or unacceptable
Treatment for: Multiple Myeloma toxicity precludes the use of amphotericin B deoxycholate as well as
Tecvayli (teclistamab-cqyv) is a bispecific B-cell maturation antigen in the treatment of visceral leishmaniasis.In immunocompromised
(BCMA)-directed CD3 T-cell engager indicated for the treatment patients with visceral leishmaniasis treated with amphotericin B
of adult patients with relapsed or refractory multiple myeloma liposome for injection, relapse rates were high following initial
who have received at least four prior lines of therapy, including a clearance of parasites.
proteasome inhibitor, an immunomodulatory agent and an anti- US FDA grants fast track designation to Immunomic Therapeutics’
CD38 monoclonal antibody. pDNA vaccine, ITI-3000 to treat Merkel cell carcinoma
Imjudo (Tremelimumab-actl) Injection www.pharmabiz.com; 10th November, 2022
Company: AstraZeneca Immunomic Therapeutics, a privately-held clinical-stage
Date of Approval: October 21, 2022 biotechnology company pioneering the development of LAMP-

Pharma Times - Vol. 54 - No. 11, November 2022 37

mediated nucleic acid-based immunotherapy, announced that facility. It was inspected by the US Food and Drug Administration
the US Food and Drug Administration (FDA) has granted Fast (USFDA) in February 2019 and issued a warning letter in June
Track Designation (FTD) to the ITI-3000 programme for the 2019. It was inspected further by the USFDA from July 25 to August
treatment of patients with Merkel cell carcinoma. The company 2, 2022 and issued a Form 483 with three observations. Form
is currently enrolling a phase 1 study evaluating ITI-3000, a 483 is issued to a firm’s management at the conclusion of an
plasmid DNA (pDNA) vaccine targeting patients with Merkel cell inspection when the investigator has observed any conditions that
carcinoma (MCC), a rare but aggressive form of skin cancer that may constitute violations of the Food Drug and Cosmetic (FD&C)
is typically caused by the Merkel cell polyomavirus (MCPyV). Act and related Acts.
ITI-3000 leverages the company’s investigational UNiversal Sun Pharma’s Mohali plant in Punjab receives OAI status from
Intracellular Targeted Expression (UNITE) platform, powered by USFDA
LAMP (Lysosome Associated Membrane Protein), which fuses
www.business-standard.com; 8th November, 2022
sequences from the mutated form of the large T antigen (LT) of
the MCPyV into the sequence of the LAMP-1 gene. This lysosomal Sun Pharmaceutical Industries said that their Mohali plant in
targeting technology has been shown to result in enhanced Punjab received an official action indicated (OAI) classification
antigen presentation and a balanced immune response, from the US Food and Drug Administration (USFDA). This can
including, of note, ITI-3000 activated antigen-specific CD4+ T impact approvals pending for products, but does not impact
cells in vivo. Fast Track Designation is designed to facilitate the the current business from the facility. The plant was inspected
development and expedite the FDA review of drugs to treat serious in August and had received a form 483 with six observations
conditions and fulfill unmet medical needs, enabling drugs to earlier. The typical process is that the firm concerned responds
reach patients earlier. to the queries raised by the FDA and a resolution is based on
whether the FDA is satisfied by the corrective actions taken by the
Eli Lilly introduces medication for early stage breast cancer
company. Sun Pharma has now received communication from the
www.economictimes.indiatimes.com; 24th November, 2022 FDA determining the classification of the inspection. Sun Pharma
Drug firm Eli Lilly and Company (India) has launched a product to continues to cooperate with the USFDA and will undertake all
treat early stage breast cancer after receiving approval from the necessary steps to resolve these issues and to ensure that the
Drug Controller General of India. The company has introduced regulator is completely satisfied with the Company’s remedial
Ramiven in strengths of 50 mg, 100 mg, 150 mg and 200 mg, for action.
treating early breast cancer (EBC). In India, over 50,000 patients IOL Chemicals gets EDQM certification for API supply to Europe
are diagnosed with early breast cancer (EBC) every year. Breast
www.economictimes.indiatimes.com; 7th November, 2022
cancer is the cancer which is most prevalent amongst women in
India. It significantly impacts the quality of life of survivors and IOL Chemicals and Pharmaceuticals has received a certificate
their families, who live with the fear of recurrence. of suitability from EDQM to supply Pantoprazole Sodium
Sun Pharma gets USFDA nod for drug to treat neonatal seizures Sesquihydrate API in European markets. The European
Directorate for the Quality of Medicines & HealthCare (EDQM)
www.economictimes.indiatimes.com; 18th November, 2022
is a mandatory certification for distribution of any API/ pharma
Sun Pharmaceutical Industries has received an approval from products in Europe. Pantoprazole Sodium Sesquihydrate, an
the US health regulator for SEZABY, a formulation used for active pharmaceutical ingredient (API), is a proton pump inhibitor
treatment of neonatal seizures. SEZABY is a benzyl alcohol-free
used in drugs to suppress the gastric acid secretion. The company
and propylene glycol-free formulation of phenobarbital sodium
started production of Pantoprazole Sodium Sesquihydrate in Q3
powder for injection. It was granted orphan drug designation by
the US Food and Drug Administration (USFDA) for the treatment FY 2020 at its Punjab-based facility. With this CEP (certificate of
of neonatal seizures. Orphan drug designation is granted by the suitability) certification, the company will now be able to export it
USFDA to a medicine intended to treat a condition affecting fewer to entire Europe. IOL is the world’s largest producer of Ibuprofen
than 2 lakh persons in the US, or which will not be profitable within API with 33 per cent market share globally. The company has
seven years following its approval. With this approval, SEZABY 13 plus APIs in its portfolio such as Metformin Hydrochloride,
becomes the first and only product specifically indicated in the Clopidogrel Bisulfate Form II, Fenofibrate, Paracetamol etc. The
US for the treatment of neonatal seizures in term and pre-term European Medicines Agency (EMA) and EDQM cooperate on
infants. The drug is expected to be available in the US in the fourth matters aimed at ensuring the quality of medicines and protection
quarter of FY23. Sun Pharma Advanced Research Company Ltd of public health in Europe.
(SPARC) had recently licensed SEZABY to Sun Pharma, under USFDA issues Form-483 with 3 observations to Alkem Lab’s St
which SPARC is eligible to receive a milestone payment on Louis plant
approval of SEZABY by the USFDA.
www.economictimes.indiatimes.com; 10th November, 2022
Alkem Laboratories said the US health regulator has issued three
REGULATORY AFFAIRS observations after inspecting its St Louis-based manufacturing
Aurobindo Pharma receives EIR from USFDA for its Andhra facility. The US Food and Drug Administration (USFDA) had
Pradesh facility conducted a pre-approval inspection at the plant. At the end of the
www.business-standard.com; 16th November, 2022 inspection, the company received Form 483 with three observations.
Aurobindo Pharma has received an Establishment Inspection As per USFDA, Form 483 is issued to a firm’s management at the
Report (EIR) from the US health regulator for its manufacturing conclusion of an inspection when the investigator has observed
facility at Pydibhimavaram in Andhra Pradesh. The company’s any conditions that in its judgment may constitute violations of the
Unit XI at Pydibhimavaram is an API non-antibiotic manufacturing Food Drug and Cosmetic (FD&C) Act and related Acts.

Pharma Times - Vol. 54 - No. 11, November 2022 38

Mylan Institutional LLC, a Viatris Company, Issues a Voluntary bAflibercept to treat several ophthalmology conditions. Viatris has
Recall of One Lot of Octreotide Acetate Injection, 500 mcg/mL, been the ‘first to file’ bAflibercept in the US. Now, Biocon Biologics
Due to Glass Particulates in a Syringe has a que portfolio of 20 biosimilar assets, including insulins and
www.fda.gov; 25th October, 2022 monoclonal antibodies for diabetes, oncology, immunology and
ophthalmology.
Mylan Institutional, a Viatris company, is voluntarily recalling a lot
of Octreotide Acetate Injection, 500 mcg/mL, packaged in a carton AstraZeneca to buy clinical-stage biotech company, Neogene
of ten 1mL syringes. This lot is being recalled at the user (hospital/ Therapeutics for $320 million
pharmacy) level due to a product complaint of the presence of www.pharmabiz.com; 30th November, 2022
glass particles in a syringe. Intravenous administration of a solution AstraZeneca announced an agreement to acquire Neogene
containing particulate matter, such as a glass, could lead to events Therapeutics (Neogene), a global clinical-stage biotechnology
including, but not limited to, local irritation or swelling, vasculitis/ company pioneering the discovery, development and manufacturing
phlebitis, antigenic or allergic reactions, and microvascular of next-generation T-cell receptor therapies (TCR-Ts) that offer a
obstruction, including pulmonary embolism. Although the novel cell therapy approach for targeting cancer. With a shared goal
intravenous administration of a solution containing particulate of bringing cell therapies to patients with solid tumours, Neogene’s
matter may pose potential risk of serious adverse events, the expertise in TCR-T discovery, development and manufacturing
probability of exposure from this incident and subsequent risk is will strengthen AstraZeneca’s ambition to transform outcomes
low. To date, no reports of adverse reactions associated with this for patients. TCR-Ts are emerging as a promising therapeutic
lot have been received. modality in cancer treatment. Most current cell therapy approaches
USFDA issues Form-483 with 8 observations to Lupin’s drug, API in oncology focus on modifying the immune system’s T cells to
production facilities in Mandideep plant recognise proteins expressed on the surface of cancer cells. In
www.economictimes.indiatimes.com; 24th November, 2022 contrast, TCR-Ts can recognise intracellular targets, including
cancer-specific mutations, thereby potentially unlocking targets
Drug maker Lupin said the US health regulator has issued Form-
previously inaccessible using cell therapies. Neogene will operate
483 with eight observations each for product and raw material
production centres at its Mandideep-based manufacturing facility. as a wholly owned subsidiary of AstraZeneca, with operations in
The US FDA had inspected the Mandideep Unit-1 facility in Madhya Amsterdam, the Netherlands and California, US. AstraZeneca will
Pradesh from November 14, 2022, to November 23, 2022. The acquire all outstanding equity of Neogene for a total consideration
inspection of the facility closed with issuance of a Form-483 with of up to $320 million, on a cash and debt free basis. This will include
eight observations each for the drug product facility and active an initial payment of $200 million on deal closing, and a further
pharmaceutical ingredient (API) facility at the site. The company is up to $120 million in both contingent milestones-based and non-
committed to addressing the observations and will work with the contingent consideration. The transaction is expected to close in
US health regulator to resolve the issues at the earliest. On October the first quarter of 2023, subject to customary closing conditions
30, the drug maker announced that the US health regulator has and regulatory clearances.
issued Form-483 with five observations following a pre-approval Mankind Pharma acquires stake in Upakarma Ayurveda for
inspection of its Unit-2 injectable manufacturing facility at Nagpur. undisclosed sum
www.business-standard.com; 28th November, 2022
MERGERS, ACQUISITION AND COLLABORATION Mankind Pharma has acquired a majority stake in Upakarma
Biocon Biologics completes acquisition of Viatris’ global Ayurveda, engaged in developing, manufacturing and selling
ayurvedic and herbal products for an undisclosed amount. The
biosimilars business
company’s decision to invest will empower Upakarma Ayurveda
www.pharmabiz.com; 30th November, 2022 to develop a wider range of products and offerings. Mankind
Biocon Biologics, a subsidiary of Biocon has successfully completed Pharma acquired the ayurvedic solutions firm through one of its
its multi-billion-dollar (USD) acquisition of the global biosimilars subsidiaries.
business of its partner Viatris. The two companies have obtained Regeneron and CytomX Announce Strategic Research
all applicable approvals from key global regulators including Collaboration in the Field of Conditional Bispecific Therapeutics
the US Federal Trade Commission, Competition Commission of for the Treatment of Cancer
India, Reserve Bank of India, and its investors. The acquisition www.prnewswire.com; 17th November, 2022
provides Biocon Biologics with direct commercial capabilities and
Regeneron Pharmaceuticals has announced a collaboration
supporting infrastructure in the advanced markets and several
and licensing agreement to create conditionally-activated
emerging markets, bringing it closer to patients, customers, and
investigational bispecific cancer therapies utilizing CytomX’s
payors. The integration of Viatris’ acquired global biosimilars Probody therapeutic platform and Regeneron’s Veloci-Bi bispecific
business and Biocon Biologics’ existing capabilities in research and antibody development platform. The collaboration is strategically
development, global scale manufacturing and commercialization focused on applying CytomX’s biologic masking strategies to
in several emerging markets positions Biocon Biologics as a develop investigational Regeneron bispecifics that remain inactive
leading global biosimilars player to provide equitable access to until activated by proteases in the tumor microenvironment. This
high quality, lifesaving biosimilar medicines. With the closing of technology has the potential to widen the therapeutic window
the deal, Biocon Biologics has full ownership of its collaboration and help minimize off-target effects for these next-generation
assets, bTrastuzumab, bPegfilgrastim, bBevacizumab, bGlargine, T-cell engaging therapies, potentially addressing tumor types
bAspart, bPertuzumab and bGlargine 300U, as well as Viatris’ that have historically been unresponsive to immunotherapy. This
rights for the in-licensed immunology products of bAdalimumab and collaboration will enable Regeneron and CytomX to combine their
bEtanercept. Biocon Biologics has also acquired Viatris’ rights for collective oncology expertise with two premier platforms, Probody

Pharma Times - Vol. 54 - No. 11, November 2022 39

and Veloci-Bi to develop novel immunotherapies and research 1,600 employees across the five brands that make up Norstella.
their potential to transform patient lives. Regeneron will be This merger will allow Norstella to prioritize rapid innovation to help
responsible for funding preclinical and clinical development and guide life sciences companies through the entire drug development
commercialization activities. process so patients can get access to therapies quicker. As a
J&J to buy heart pump maker Abiomed in $16.6 bln deal combined organization, Norstella’s solutions will empower pharma
stakeholders to identify unmet clinical needs early, construct
www.economictimes.com; 1st November, 2022
clinical trials with informed endpoints that support downstream
Johnson & Johnson struck a deal to buy heart pump maker reimbursement decisions, and precisely identify eligible patients
Abiomed, as it looks to boost growth at its medical devices unit for clinical trials. This union is an opportunity for both Citeline and
after next year’s planned spinoff of its consumer health business. Norstella to advance their shared mission of making therapies
Abiomed develops medical technology that provides circulatory available to the patients who need them.
and oxygenation support. J&J is focused on its pharmaceuticals
Marksans Pharma acquires Teva’s manufacturing site in Goa
and medical devices operations with the consumer health spinoff
expected by November 2023. They will prioritize building up www.economictimes.com; 12th October, 2022
the medical devices unit through acquisition. This acquisition is Marksans Pharma has entered into an agreement with Israeli
consistent with the strategy, expanding J&J medtech into high- drug maker Teva’s manufacturing site in Goa on a slump sale
growth markets and accelerating revenue growth while advancing basis. The Mumbai-based Marksans has agreed to retain the
the standard of care. The deal, expected to close before the end site employees with existing terms of employment. Teva’s
of the first quarter of 2023, will add to adjusted earnings from affiliate Watson Pharma will continue to own and operate its
2024. Beyond the new products Abiomed is developing, J&J’s other manufacturing site at Verna Industrial Estate, Verna
existing infrastructure can be used to expand Abiomed’s reach Salcette, Goa, India. Marksans will continue to supply Teva’s
outside the U.S. affiliates for certain products until the end of FY23 as part of
Citeline and Norstella Complete Merger to Form a $5 Billion the agreement, which can be extended further with mutual
Global Pharmaceutical Technology Company agreement. Through acquisition of Teva’s manufacturing
www.prnewswire.com; 1st November, 2022 plant, Marksans plans to double the existing Indian capacity
Norstella, a global leader with end-to-end solutions that smooth from 8 billion units per annum currently. Marksans plans to
access to life-saving therapies for patients, has announced manufacture tablets, hard and soft gel capsules, ointments,
the completion of its merger with Citeline (formerly Pharma gummies, creams, from the new capacity. This acquisition has
Intelligence), a leader in the clinical trial intelligence space. At deal potential to significantly expand the manufacturing capability
close, the global company is now one of the world’s largest pharma of Marksans Pharma and accelerate its core growth strategy. It
intelligence solutions providers on the market, with more than will also supplement their innovative product portfolio in India.

Pharma Times - Vol. 54 - No. 11, November 2022 40

 Central Bus stand to the Collectorate, Trichy. Dr. G. Govindaraj,
during his speech deliberated that the rally was organized with
the aim to create awareness about breast cancer among women
and he stressed that the programme becomes successful
when women come forward to get themselves screened. Dr.
R. Senthamarai, Principal, during her felicitation address
emphasized that women are the most affected people by cancer,
Periyar College of Pharmaceutical Sciences, Tiruchirappalli because of their negligence in their own health; it is important
Breast Cancer Awareness Lecture and Free Screening Camp for the women to become health conscious. The students carried
posters and placards with awareness messages with pink ribbons
to create breast cancer awareness. During this rally, a street play
was done with aid by nursing students to create breast cancer
awareness among the public.

Smriti College of Pharmaceutical Education, Indore

MP Pharma Academicians Friendly Cricket Match Season II

On the eve of Breast Cancer Awareness Month (Pink October

2022), The Periyar Health Club of our college along with
Harshamitra Super Specialty Cancer Hospital and Research
Institute, Trichy jointly organized a Breast Cancer Awareness
Lecture and Free Screening camp on 21st October 2022. Prof. A.
Jayalakshmi, N.S.S. Programme officer welcomed the gathering.
Dr. R. Senthamarai, in her presidential address deliberated that
the dreadful disease cancer is one of the major cause of death in
public. She also emphasized that women must give importance to
their health without any inhibition or hindrance and come forward
to undertake tests for breast examination so that this dreadful
disease will be eradicated from the society. Dr. G. Govindaraj
during his lecture highlighted the self examination procedure to
identify any lump in the breast and advised the women community
to protect themselves by early examination with aid of advanced
Smriti College of Pharmaceutical Education, Indore organized
diagnostic procedures such as Thermogram and Mammogram.
Pharma Academicians Friendly Cricket Match Season II on 6th
He also stressed that women are the backbone of the society and
November 2022. Around 30 colleges with 82 mentors and 18
it is imperative for men to give more attention to the health of
principals from different corners of the MP. The vision behind
women of their families. Dr. Yamini felicitated the gathering by her
organizing this tournament was the foresightedness on the part
presence. Free breast examination and Thermogram screening
of Dr. Neelesh Malviya Principal, Smriti College to have the idea
was carried out on the staff members of Periyar Centenary
of a cricket match to raise the powerful voice to communicate
Educational Complex, Trichy.
the message of ethics and harmony in pharma academicians.
The guest team was given certificates and gifts to appreciate
Breast Cancer Awareness Rally their efforts. The event came to an end with an inspiring speech
and the vote of thanks by Dr. Neelesh Malviya, Principal, Smriti
College of Pharma Education, Indore.

Delhi Pharmaceutical Sciences and Research University,

Delhi
Hardin Harghar Ayurveda Celebration at DPSRU
Delhi Pharmaceutical Sciences and Research University
organized a one week programme from October 3- October 8,
2022, on the theme “Hardin Harghar Ayurveda” to celebrate
“Ayurveda @ 2047 – Azadi ka Amrit Kaal” which highlighted
On the eve of Breast Cancer Awareness Month (Pink October the contribution of Ayurveda in dealing with the management
2022), the Periyar Health Club of our college along with of chronic lifestyle related diseases and non communicable
Harshamitra Super specialty Cancer Hospital and Research diseases, with a special focus on the elderly. On the very first
Institute, Trichy jointly organized a Breast Cancer Awareness rally day, an inauguration ceremony was held to kickstart the grand
on 19th October 2022. The 7 km walk started from Periyar Statue, celebrations. Honourable Vice- Chancellor, Prof. R. K. Goyal

Pharma Times - Vol. 54 - No. 11, November 2022 41

explained the modern perspectives of Ayurveda and also gave an World Students Day was celebrated by Gahlot Institute of
overview on the development of the Ayurveda programme in DPSR Pharmacy, Koparkhairane by organizing ‘FASTEST FINGERS
University. Prof.(Dr.) P.K. Prajapati delivered a keynote address FIRST’ an online National Quiz for final year students of Diploma
in Pharmacy on 16th October 2022. The event was sponsored by
Brilliant Publication, Pune. More than 550 students registered
for this one-of-a-kind event. The toppers were awarded with
certificates of excellence and cash prizes of Rs 3000, Rs 2000
and Rs 1000 respectively. The event was organized by Dr Smita
Nayak, HOD, Diploma in Pharmacy under the guidance of
Principal, Dr. V.H. Bhaskar.

Nalanda College of Pharmacy, Nalgonda

National Conference on ‘Recent Advances and Issues in
Pharmaceutical Education & Research (NCOP RAIPER-2022)
and spoke about the aim of Ayurveda and branches of Ayurveda.
Prof. Prajapati suggested how to delay or prevent various disorders
associated with age and their treatment. Prof. (Dr.) Rabinarayan
Acharya explained Ayurveda and treatment related to it on
different body systems. He also highlighted the scope of pharma
students in Pharmacokinetic and Pharmacodynamics studies of
Ayurvedic formulations. On the second day, DPSRU organized a
free health check up for senior citizens. The third day, October
5, 2022, DPSRU celebrated Dussehra with an online session on
Ayurvedic Practices for Senior Citizens. The rally was followed
by an expert talk session. On the 5th day (October 7, 2022)
celebration of “Har Din Har Ghar Ayurveda” a visit was made to
the old-age home “ Mann Ka Tilak ‘’. On the final day of this week-
long celebration, a symposium was held on October 8, 2022 on GK
Narayana Auditorium at DPSRU that was graced by the presence of
Honourable Chancellor LG Shri Vinai Kumar Saxena, Honourable
Vice Chancellor Prof. Ramesh K. Goyal, Director, AIIA, Prof. Tanuja
Nesari, BOG Chairman Dr. Shridhar Dwivedi, Ms. Alice Vaz R., Nalanda College of Pharmacy, Nalgonda, Telangana organized
Secretary, Government of NCT of Delhi, and other dignitaries, national conference on ‘Recent Advances and Issues in
along with faculty members, students and staff. Shri Vinai Kumar Pharmaceutical Education & Research (NCOP RAIPER-2022)’ on
Saxena spoke of the relevance of ayurveda in India since ages. 22nd October 2022. Conference was witnessed by Sri P. Mohan
The programme ended with the inauguration of DPSRU’s annual Reddy, Secretary, Nalnda College of Pharmacy as ‘Chief Patron’;
magazine, Pharmannual 2021-2022. This above session was Sri G. Krupakar Reddy, Academic Advisor, Nalnda College of
followed by a technical session in the first of which, Prof. C.R. Babu Pharmacy as ‘Patron’; Dr. K. N. V. Rao, Principal & Professor,
took an expert lecture. Prof. Babu spoke on “Bio-Diversity as a Nalnada College of Pharmacy as ‘Convener’; Dr. Suresh V.
source of future drugs”. DR. Rajiv Rai, Head, Healthcare, Dabur
Chennupati, Professor & HOD, Pharmaceutical Analysis, Nalnda
India - talked about the health benefits of Ayurveda.
College of Pharmacy as ‘Co-convener’; Dr. Abdul Rahaman,
Principal & Professor, Nirmala College of Pharmacy, Mangalagiri,
Gahlot Insititute of Pharmacy, Koparkhairane Guntur, Andhra Pradesh as ‘Special Guest’ and Dr. B. V. S
World Students Day Lakshmi, Professor & Head, Pharmacology, School of Allied
Health Sciences, Malla Reddy university, Hyderabad as ‘Guest
of Honor’. Scientific session was initiated with the inaugural
lecture of Dr. Abdul Rahaman, Principal & Professor, Nirmala
College of Pharmacy, Mangalagiri, Guntur, Andhra Pradesh,
who addressed the gathering on ‘Artificial Intelligence in Drug
Discovery and Clinical Research‘. Prof. Rahaman emphasized
on the fact that research generates new knowledge as well as
forms the backbone for development of individuals as well as
organizations. Scientific session was continued with lecture of
Dr. B.V.S Lakshmi, Professor & Head, Pharmacology, School of
Allied Health Sciences, Malla Reddy university, Hyderabad on the
topic ‘Pharmacovigilance: Basic Concepts, Future Challenges and
Opportunities after Covid-19’.

Pharma Times - Vol. 54 - No. 11, November 2022 42

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2022
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Pharma Times -- Vol.

Vol. 54
54 -- No.
No. 04-05, April-May
11, November 2022 4440
2022