BEFORE THE HON’BLE SUPREME COURT OF HAPPINDIA
ORIGINAL JURISDICTION
CIVIL WRIT PETITION No.0000A of 2019
IN THE MATTER OF
The Merry Nadu Chemists and Druggists Association .....Petitioner
Rep by its General Secretary, Mr. Rajamallan
versus
The Union of Happindia …..Respondent
Through the Department of Health and Family Welfare
-AND-
ORIGINAL JURISDICTION
CIVIL WRIT PETITION No.0000B of 2019
IN THE MATTER OF
Miracle Vapour Private Ltd., .....Petitioner
Rep by its General Secretary, Mr. Abdul Ajes
versus
The Union of Happindia …..Respondent
Through the Department of Health and Family Welfare
FACTS OF THE CASE:
GENERAL
Happindia is one of the oldest civilizations in the world with a kaleidoscopic variety and
rich cultural heritage. It has achieved all-round socio-economic progress during the last 73 years
of its Independence. It has now become one of the top industrialized countries in the world.
Happindia has advanced in terms of digital competitiveness in the world as the country has
improved in terms of knowledge and future-readiness to adopt and explore digital technologies.
The increasing number of Internet users in Happindia is a result of a number of factors, including
the growth in the use of personal computers, advances in high-speed connectivity, and the
availability of a broader range of online products and services.
PART-1
Happindia is among the leading global producers of cost-effective generic medicines and
vaccines, supplying 20 percent of the total global demand by volume. The country has an
established domestic pharmaceutical industry, with a strong network of 3000 drug companies
and about 10,500 manufacturing units. Out of these, 1,400 units are World Health Organization
(WHO) good manufacturing practice (GMP) approved; 1,105 have Europe’s certificate of
suitability (CEPs); more than 950 match therapeutic goods administration (TGA) guidelines; and
584 units are approved by the US Food and Drug Administration (USFDA).
The Happindian pharmaceutical industry is aspiring to touch USD 120-130 billion by
2030 from the current USD 38 billion. To achieve the goals of Vision 2030, the stakeholders are
accelerating towards the goal of universal healthcare across Happindia and the world by
providing access to high-quality affordable drugs.
With the widespread societal use of the Internet, it is of no surprise that a broad and
growing array of health care information, services and products, including pharmaceuticals, are
being offered online. It is estimated that more than 250 online pharmacies have sprung up in
Happindia in recent years, cornering Rs. 1,000 crore ($140 million) of the Happindian drug
market.
Happindia’s pharmacy laws are derived from the Drugs and Cosmetics Act, 1940, Drugs
and Cosmetics Rule, 1945, and the Pharmacy Act, 1948. These laws predate the advent of online
commerce in India, leaving the business out of the purview. Drugs and Cosmetics Act, 1940 and
Rules 1945 were passed with the aim to ensure that only qualified personnel are engaged in
manufacturing, importing, distribution and sale of drugs and cosmetics, confirming safe and
effective drugs and cosmetics are being sold. It also prevents entry of substandard drugs and
cosmetics in the Indian market.
But the rapid growth of e-commerce continues to pose challenges to the State and Central
Governments in the trade of online pharmacy. Massive protests took place all over the country,
when Maxon, Spinkart and Smack seal, leading e-commerce companies, entered in general retail,
which is being continued in retail medicine.
Meanwhile, a complaint was lodged in Smilepur police station by one Mr. Ashok Hari
Singh, that on 15.02.2019, the de facto complainant had taken his minor son to the clinic of
Dr. Eesh Samba who administered Polio, DPT and HIB vaccines to the child from his own stock.
After returning home the child became very sick and started vomiting and became seriously ill
and was taken to doctor known to the informant and after a proper treatment the child was cured.
The informant noticed that in the vial both manufacturing date and expiry date were interpolated,
where manufacturing date 31st January, 2009 was changed by pen into 2019 and expiry date
January, 2012 was converted into 2022. The informant learnt from Dr. Eesh that the said
vaccines were purchased at a discounted rate from the e-commerce platform maxon.in. On the
basis of the said complaint, Smilepur P.S has registered a First Information Report on 15.02.2019
against Dr. Eesh Samba and Members of the Maxon board, under Sections 274 and 275 of
Happindian Penal Code read with Section 27 of the Drugs and Cosmetics Act, 1940. The case
against Maxon dominated the country's media on 15.02.2019.
On Investigation, Mrs. Shanthini, Country Head of Maxon Happindia said that Maxon
cannot be held liable for third-party seller products as the vaccines are supplied by Allaga
Pharma Ltd. She quoted clause 3 of Terms of Conditions of Use which states as follows:
“Maxon is only a facilitator and is not and cannot be a party to or control in any manner
any transactions on the website. Accordingly, the contract of sale of products on the website
shall be a strictly bipartite contract between you and the sellers on Maxon.in.”
She further stated that Dr. Eesh Samba has purchased the medicine even after the
following strong highlighted pop-up notification disclaimer on the webpage:
“The product you are accessing is a Third-party product and any transaction is at your
own risk. Kindly ensure using your best and prudent judgment before entering into any
transactions through this webpage”
On the basis of the said FIR, after completing the investigation the police submitted the
chargesheet on 17.04.2019, against Dr. Eesh Samba and added the name of the proprietor of
Allaga Pharma Ltd. but excluded the names of Members of Maxon Board. On the basis of such
chargesheet learned SDJM has taken cognizance of offence.
On 22.04.2019, a Writ Petition has been filed in Supreme Court of Happindia for
blocking the link of all such websites from Happindia, who are engaged in online sale of
medicines in violation of the Drugs and Cosmetics Rules, 1945. The petitioner is an Association
of the Merry Nadu Chemists and Druggists (The Merry Nadu Chemists and Druggists
Association) represented by its General Secretary Mr. Rajamallan. His contention is that
permitting sale of drugs through Internet/online defeats the purpose of the provisions of the
Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules framed thereunder to
safeguard the public interest, which regulates the manufacture and sale to ensure quality and
availability under prescribed storage conditions by qualified pharmacists. It is averred in the
petition that there are provisions under the Drugs and Cosmetics Act for recalling drugs due to
very serious side-effects from the market and this would be possible only if the medicines are
sold by the pharmacists, who are aware of the movement of the medicines till it reaches the
patients. There is no guarantee for data privacy if the medicines are sold online. Diseases and
treatments are private and confidential information of the patients, which cannot be made
available for data mining and for commercial use by online pharmacists. The petition also
contains the facts and details of the FIR filed against Maxon.
While the respondent relied upon the benefits and advantages of e-pharmacies, it is also
stated by the respondent that the Sub-Committee constituted by the Drugs Consultative
Committee (DCC) to examine the issue relating to the sale of drugs over the internet has
submitted its report to the DCC, which in turn, in its 50th meeting held on 4th and 5th November,
2016, has accepted the report and the same has been forwarded to Ministry of Health and Family
Welfare for consideration. Based on the report, on September 2018, the Union Health Ministry
of India released the draft rules on sale of drugs by E-Pharmacies in order to regulate online sale
of medicines in Happindia. And the same is pending for further discussion. It is argued that until
the implementation of draft rules there should not be any distinction between online and
conventional pharmacy. The person or company having license to sell medicine and drugs in
retail store, should be permitted to sell it online. Further, the respondent mentioned that the facts
and details of the FIR filed against Maxon are irrelevant to instant case.
Hearing the arguments, the Supreme Court has imposed an interim ban on the sale of
drugs online in Happindia on 18th September 2019.
PART-2
According to the World Health Organization (WHO), Happindia is home to 12% of the
world's smokers. More than ten million Happindians die every year from tobacco-related
diseases. This is more than the number of deaths due to motor accidents, AIDS, alcohol and drug
abuse put together.
The Cigarettes and Other Tobacco Products (Prohibition of Advertisement and
Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003(COTPA),
was first ever anti-tobacco legislation in Happindia. This important Act was introduced in the
face of stiff resistance of the tobacco lobby. The preamble of the Act states “it is expedient to
prohibit consumption of cigarettes and other tobacco products which are injurious to health with
a view to achieving improvement of public health in general as enjoined by Article 47 of the
Constitution.” Happindia is now looking to amend COTPA 2003 to plug its loopholes.
Despite strenuous opposition, Happindia succeeded in getting large size (85%) warning
on tobacco packs along with the Quit line number. Free multilingual telephonic counselling is
successfully assisting tobacco users to quit the habit. Happindian Government ensured better
implementation of gutka and flavoured chewing tobacco ban. It also launched one of the most
graphic anti-tobacco awareness campaigns on Happindian television and cinema halls.
With the advent of various outstanding “Tobacco Free Happindia” programmes,
Happindia has shown 17% relative decrease in tobacco consumption between 2010 and 2016.
In the midst of declining cigarette consumption, cigarette companies introduced
e-cigarettes to remain profitable. These newer products are being deceptively promoted as a less
harmful alternative to cigarettes. The liquid in the e-cigarette usually contains nicotine, which is
toxic, highly addictive and known to be a lethal chemical. To make it more appealing to kids,
more than 7,000 varieties of flavours are mixed in the liquid. Apart from nicotine, e-cigarette
cartridges can also be used as delivery devices for addictive and harmful substances such as
cannabis and opiates.
E-cigarette industry targets youth as potential customers – many of whom are never-
smokers who view the devices as a form of recreation and sometimes a fashion statement. When
used by never-smokers, these devices can be a gateway for cigarette smoking and other drug use.
As per the Happindia National Youth Tobacco Survey, e-cigarette use acquired epidemic
proportions and increased by 77.8% among high school students and by 48.5% among middle
school students from 2017 to 2018, only in one year. Even though there are apparent evidences
of “harm reduction” as well as any cessation benefits of these products, a contradicting newer
evidence of harm is emerging, as demonstrated by the outbreak of severe lung disease due to
vaping in Happindia, where more than 400 people were affected and 12 reportedly died. Their
use for cessation is not yet approved under the Drugs and Cosmetics Act. Alarmed by these
statistics and emerging evidence, various expert committees and institutions petitioned the
ministry of health to ban e-cigarettes before they became an epidemic.
However, no legislation were in place to ban these hazardous products across Happindia.
Therefore, on September 18, 2019, Happindia government took a bold step by promulgating the
Prohibition of Electronic Cigarettes (production, manufacture, import, export, transport, sale,
distribution, storage and advertisement) Ordinance, 2019.
Miracle Vapour Private Ltd., moves the writ petition in Supreme Court of Happindia
challenging the Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export,
Transport, Sale, Distribution, Storage and Advertisement) Ordinance, 2019 dated 18th September,
2019.
GENERAL
Concerning the importance of public health and safety in both part-1 and part-2 cases, the
Chief Justice of Happindia established a special bench and termed it as BAN BENCH to decide
upon the lifting of ban imposed on E-pharmacies and E-cigarettes.
- The Ban Bench posted both the cases for final hearing.
As a matter of rule, Speaker-1 will be the representing counsel for Part-1 dispute and
Speaker-2 will be for Part-2 dispute.
The legal system and legislations of Happindia are in parimateria with that of Republic of
India
© This Moot proposition was drafted by M.A. Saleem Ahmed, Research Scholar, Vels School of
Law, Vels Institute of Science, Technology & Advanced Studies.
All names of individuals mentioned in this problem are fictitious. Any resemblances to person(s),
place(s), period(s) or entitites in real life are purely coincidental.
None of the facts above are intended to depict anyone or any pending litigation. All facts stated
herein are for the purpose of academic research and may be taken in that light only.
