The DRUGS AND

COSMETICS ACT, 1940 AND

ITS RULES, 1945
 History & Introduction
 Position till 1930, India was largely dependant on import of modern
medicines until after first world war.
 In 11th August 1930, the Government of India appointed a Drug Enquiry
Committee under the Chairmanship of Colonel R.N Chopra, to go in to
the question of adulterated and substandard drugs sold in country and
to recommend step by step by which this menace could be control.
 The Drug Enquiry Committee submitted its first report in 1931. The
Government of India couldn’t give effect to its recommendation till
1937.
 After passing of the Government of India Act 1935, drug became
provincial subject & therefore centre could pass law in respect of only
Import.
 The Drug Import Bill was prepared & placed for consideration before
the assembly in 1939.This was not acceptable to the public & provinces
for uniform & comprehensive legislation. It was passed & received
assent of Governor General in Council & became Drug Act in 1940.
 Aims & Objectives:
 The Drugs and Cosmetics Act passed in 10th April 1940 with the main object to
 Regulate the
➢ Import,
➢ Manufacture,
➢ Distribution and
➢ Sale of drugs and Cosmetics in the country.
• The Act regulates the import of drugs in India, so that no substandard or spurious
drug will enter into our country
• The Act prohibits the manufacture of the substandard or spurious drug in the
country
• The Act provide for the control over the sale and Distribution of drug by only
trained/Skilled and qualified persons.
• The Act also provide for the control over the manufacture, sale & distribution of
Ayurveda, Siddha, Unani & Homeopathic drugs.
 To create and develop an Administrative machinery necessary to regulate the
provision of the Act.
 Creating a Licensing Authority to issue or grant licences for manufacture,
Distribution and Sale of drug and cosmetics
 Provision for the establishment of Drug Technical Advisory Board, to advice the
government on technical matters and implementation of the Act.
Definition:
“Drug” includes—
 (i) All medicines for internal or external use of human beings or animals and
all substances intended to be used for or in the diagnosis, treatment,
mitigation or prevention of any disease or disorder in human beings or
animals, including preparations applied on human body for the purpose of
repelling insects like mosquitoes;
 (ii) Such substances (other than food) intended to affect the structure or any
function of human body or intended to be used for the destruction of
(vermin) or insects which cause disease in human beings or animals, as may
be specified from time to time by the Central Government by notification in
the Official Gazette;
 (iii) All substances intended for use as components of a drug including empty
gelatin capsules; and
 (iv) such devices intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human beings or
animals, as may be specified from time to time by the Central Government
by notification in the Official Gazette, after consultation with the Board
Definition:
 “Cosmetics” means any article intended to be rubbed, poured,
sprinkled or sprayed on, or introduced into, or otherwise
applied to the human body or any part thereof for cleaning,
beautifying , promoting attractiveness, or altering the
appearance, and include any article intended for use as a
component of cosmetics.
 “Ayurvedic, Siddha or Unani drug” includes all medicines
intended for internal or external use for or in the diagnosis,
treatment, mitigation or prevention of [disease or disorder in
human beings or animals, and manufactured] exclusively in
accordance with the formulae described in, the authoritative
books of Ayurvedic, Siddha and Unani systems of medicine],
specified in the First Schedule;]
 Other terms: Board, Government analyst, Misbranded,
Adulterated, Spurious, Drug Inspectors, Manufacture, To
import, Patent, Prescribed, Presumption, Standard quality,
LEGAL DEFINITION OF SCHEDULES TO THE
ACT AND RULES:
 The Act consists of Five Chapters, and each Chapter is related to
particular subjects:
 CHAPTER-I: INTRODUCTION
 CHAPTER-II: THE DRUG TECHNICAL ADVISORY BOARD, THE
CENTRAL DRUG LABORATORY AND THE DRUG
CONSULTATIVE COMMITTEE.
 CHAPTER-III: IMPORT OF DRUGS AND COSMETICS
 CHAPTER-IV: MANUFACTURE, SALE, DISTRIBUTION OF
DRUGS AND COSMETICS
 CHAPTER-IVA: PROVISION RELATED TO AYURVEDA, SIDDHA
AND UNANI DRUGS.
 CHAPTER-V: MISCELLANEOUS

 THERE ARE TWO SCHEDULES TO THE ACT AND TWENTY

SEVEN SCHEDULES TO THE RULES.
 Schedule to the Act
1. First Schedule: Name of the Books
under Ayurveda, Siddha, Unani.
2. Second Schedule: Standard to be
compiled with by imported
drugs and by drugs
manufactured for sale, sold,
stocks or exhibited for sale or
distribution.
 BOARD, THE CENTRAL DRUGS LABOURATORY AND
THE DRUGS CONSULTATIVE COMMITTEE
(Administrative Bodies)
 The Drugs Technical Advisory Board (DTAB).
➢ The Central Government shall, as soon as may be, constitute a Board (to be
called the Drugs Technical Advisory Board) to advise the Central
Government and the State Governments on technical matters arising out of
the administration of this Act and to carry out the other functions assigned
to it by this Act.
 The Board shall consist of the following members, namely: -
 (i) The Director General of Health Services, ex officio, who shall be Chairman;
 (ii) The Drugs Controller, India, ex officio;
 (iii) The Director of the Central Drugs Laboratory, Calcutta, ex officio;
 (iv) The Director of the Central Research Institute, Kasauli, ex officio;
 (v) The Director of Indian Veterinary Research Institute, Izatnagar, ex officio;
 (vi) The President of Medical Council of India, ex officio;
 (vii) The President of the Pharmacy Council of India, ex officio;
 (viii) The Director of Central Drug Research Institute, Lucknow, ex officio;
 (ix) Two persons to be nominated by the Central Government from among persons who
are in charge of drugs control in the States;
 (x)One person, to be elected by the Executive Committee of the
Pharmacy Council of India, from among teachers in pharmacy or
pharmaceutical chemistry or pharmacognosy on the staff of Indian
University or a college affiliated thereto;
 xi) One person, to be elected by the Executive Committee of the
Medical Council of India,from among teachers in medicine or
therapeutics on the staff of an Indian University or a college affiliated
thereto;
 (
➢ The nominated and elected members of the Board shall hold office for
three years, but shall be eligible for re-nomination and re-election.
➢ The Central Government shall appoint a person to be Secretary of the Board
and shall provide the Board with such clerical and other staff as the Central
Government considers necessary.
 Functions:
❖To advice the Central Government and the
State Government on technical matters
arising out of the administration of this Act.
❖Modification & Amendments in the Act with
consultation of Board.
❖To carry out the other functions assigned to
it by this Act.
 The Drugs Consultative Committee
❑ The Central Government may constitute an advisory committee to be
called “the Drugs Consultative Committee” to advise the
Central Government, the State Governments and the Drugs
Technical Advisory Board on any other matter tending to secure
uniformity throughout [India] in the administration of this Act. .
Constitution of DCC:
➢ The Drugs Consultative Committee shall consist of
✓ Two representative Committee of the Central Government
to be nominated by that Government and
✓ One representative from State Government to be nominated
by the State Government concerned.
➢ The Drugs Consultative Committee shall meet when required to do so
by the Central Government and shall have power to regulate its own
procedure.
Functions:
 To advice the Central Government, the
State Government and the Drugs Technical
Advisory Board on any other matter tending
to secure uniformity throughout India in the
administration of this Act.
 The Drugs Consultative shall meet when
required to regulate its own procedure.
 The Central Drugs Laboratory
➢ The Central Drugs Laboratory, Kolkata is the national statutory laboratory of the
Government of India for quality control of Drug and Cosmetics and is established under
the Indian Drug & Cosmetics Act, 1940.
➢ It is the oldest quality control laboratory of the Drug Control Authorities in India.
➢ It functions under the administrative control of the Director-General of Health Services in
the Ministry of Health and FamilyWelfare.
Functions:
❑ Analysis or test of samples of drugs/cosmetics sent by the custom collectors or courts.
❑ Analytical Q.C of the imported samples.
❑ Collection, storage and distribution of internal standards.
❑ Preparation of reference standard and their maintenance.
❑ Maintenance of microbial cultures.
❑ Any other duties entrusted by Central Governmrent.
❑ Acting as an affiliated authority in matter of DISPUTES.
❑ Training of Drug analysis.
❑ To advice the Central drug control administration in respect of quality & toxicity.
❑ To work out analytical specification of Monographs for IP & Homeopathic P. copoeia.
❑ Analysis of cosmetics.
 Biological & microbiological Test/Analysis are not carried out by
C.D.L, sent to Directorate of Central Research Institute- Kasauli-
Himachal Pradesh.
 Biological for veterinary use sent to the Indian Veterinary Research
Institute, Izatnagar- Bareilly in UP.
 Test on Condoms are carried out at the Central Indian
Pharmacopoeial Laboratory, Ghaziabad-Uttar Pradesh.
Procedure:
❑All the samples of Drugs/Cosmetics sent to C.D.L. for
analysis by court under registered post & sealed with
copy of memorandum.
❑A copy of memorandum & specimen of impression of
seal on packet sent separate by registration post.
❑On receipt of the packet, the Director/Officer should
record the conditions of the seal on packet.
❑On completion of Test/Analysis, the Director/Officer
required to supply a report of the analysis.
Drug Control Laboratories in the States
 Every State has a laboratory for the analysis
& testing of the drugs & cosmetics
manufactured or sold in that particular area.
 Samples sent by D.I are analysed by such
Laboratories.
 Also analysed the drugs sent by any person
or purchaser on payment of necessary fee.
 Drug Controlling authority
 The main objective of Drugs Control Administration is to ensure that
the drugs that are made available to the people, who use them for
prevention, mitigation or treatment of diseases are of the required
standards of quality, purity and strength and are packed in containers
giving all necessary information about the drug and its manufacturer,
Drugs Control Administration regulates the manufacture, sale and
distribution of drugs in the State.
 All inspectors at central and state level are under their control.
 Drugs Controller General of India (DCGI) is the head of
department.
 Entrusted with the enforcement of Prevention of Food Adulteration Act
 Qualifications:
➢ Graduate in pharmacy/pharmaceutical chemistry/ medicine with
specialization in clinical pharmacology or microbiology from a
university established in India.
➢ He has experience in manufacture or testing of drugs or enforcement
of the provisions of the Act for minimum period of 5 years.
 Licensing Authorities
 Licensing authority means the state agency responsible for the
issuance, renewal, or reinstatement of the license, or the state agency
authorized to take disciplinary action against the licensee.
 Each state govt. employs Licensing Authority to issue licence for
manufacture of drugs & cosmetics within the state.
 Can suspend the licence
 Drug controller of India is central licence approving Authority.
Qualifications:
➢ Graduate in pharmacy/pharmaceutical chemistry/ medicine with
specialization in clinical pharmacology or microbiology from a university
established in India.
➢ He has experience in manufacture or testing of drugs or enforcement of
the provisions of the Act for minimum period of 5 years.
❖ The requirements of academic qualification is not applicable to
inspectors and Govt. analyst appointed before 12th April 1989.
(For both Licensing and Drug Controlling Authorities)
CHAPTER III – IMPORT OF DRUGS AND COSMETICS
(Section 10 of Drugs and Cosmetics act 1940)
 The central government prohibits the import of certain categories of drugs
and cosmetics by notification in Official Gazettes. No person can import the
following category of drugs and cosmetics. However, the central
government may allow the import of any one category of drug for special
purpose after consultation with the Drug Technical Advisory Board (DTAB)
1. Substandard drugs or cosmetics
2. Adulterated Drugs or Adulterated cosmetics
3. Misbranded Drugs or Misbranded Cosmetics
4. Spurious Drugs or Spurious Cosmetics
CHAPTER III – IMPORT OF DRUGS AND COSMETICS (Section 10
of Drugs and Cosmetics act 1940)
▪ Standards of quality-
 “Standard quality” means—(a) in relation to a drug, that the drug complies with the
standard set out in [the Second Schedule], and (b) in relation to a cosmetic, that the
cosmetic compiles with such standard as may be prescribed.
 (b) The Central Government, after consultation with the Board and after giving by
notification in the Official Gazette not less than three months’ notice of its intention
so to do, may by a like notification add to or otherwise amend [the Second Schedule],
for the purpose of this Chapter, and thereupon [the Second Schedule] shall be deemed
to be amended accordingly.

 Misbranded drugs. –
 “Misbranded” means (a) if it is so coloured, coated, powdered or polished that damage
is concealed or if it is made to appear of better or greater therapeutic value than it
really is; or
 (b) if it is not labelled in the prescribed manner; or
 (c) if its label or container or anything accompanying the drug bears any statement,
design or device which makes any false claim for the drug or which is false or
misleading in any particular;
Adulterated drugs. –
 (a) if it consists, in whole or in part, of any filthy, putrid or decomposed
substance; or
 (b) if it has been prepared, packed or stored under insanitary conditions
whereby it may have been contaminated with filth or whereby it may have
been rendered injurious to health; or
 (c) if its container is composed in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to health; or
 (d) if it bears or contains, for purposes of colouring only, a colour other than one which is
prescribed; or
 (e) if it contains any harmful or toxic substance which may render it injurious to health; or
 (f)if any substance has been mixed therewith so as to reduce its quality or strength.
Spurious drugs. –
 Spurious— (a) if it is imported under a name which belongs to another drug; or
 (b) if it is an imitation of , or a substitute for, another drug or resembles another drug in a
manner likely to deceive or bears upon it or upon its label or container the name of
another drug unless it is plainly and conspicuously marked so as to reveal its true character
and its lack of identity with such other drug ; or
 (c) if the label or the container bears the name of an individual or company purporting to
be the manufacturer of the drug, which individual or company is fictitious or does not
exist; or
Misbranded cosmetics-
 (a) if it contains a colour which is not prescribed; or
 (b) if it is not labelled in a prescribed manner; or
 (c) if the label or container or anything accompanying the cosmetic
bears any statement which is false or misleading in any particular.

Spurious cosmetics-
 (a) if it is imported under the name which belongs to another
cosmetic; or
 (b) if it is an imitation of, or is a substitute for, another cosmetic or
resembles another cosmetic in a manner likely to deceive or bears
upon it or upon its label or container the name of another cosmetic,
unless it is plainly or conspicuously marked so as to reveal its true
character and its lack of identity with such other cosmetic
 “Import licence” means either a licence in Form 10 to
import drugs; excluding those specified in Schedule X,
or a licence in Form 10-A to import drugs specified in
Schedule X.
 An import license will be required to import drugs
into India.
 While certain classes of drugs and cosmetics are
prohibited to be imported into India, Chapter III of
the drug and cosmetic act 1945 and Part IV
Rule number 21 to Rule Number 43 deals with
provisions of drugs and cosmetics to be
imported under drugs and cosmetics Rule 1945
(amendment 2016).
➢[Schedule X drugs …restricted drugs. List of habit
forming , psychotropic and other such drugs.]
PROHIBITION OF IMPORT OF CERTAIN DRUGS OR
COSMETICS:
 From such date as may be fixed by the Central Government by notification in
the Official Gazette in this behalf, no person shall import—
 (a) Any drug [or cosmetic] which is not of standard quality;
 (b) Any misbranded drug or misbranded (or spurious) cosmetic;
 (c) Any adulterated (or spurious) drug;
 (d) Any drug [or cosmetic] for the import of which a licence is prescribed,
otherwise than under, and in accordance with, such licence;
 (e) Any patent or proprietary medicine, unless there is displayed in the
prescribed manner on the label or container thereof (the true formula or list of
active ingredients contained in it, together with the quantities thereof);
 (f) Any drug which by means of any statement, design or device accompanying
it or by any other means, claims to cure or mitigate any such disease or ailment,
or to have any such other effect, as may be prescribed;
 (g) Any cosmetic containing any ingredient which may render it unsafe or
harmful for use under the directions indicated or recommended;
 Drugs may be imported under a licence
or permit:
 The following categories of the drugs
are imported under the licence or
permit.
➢Import of Schedule-C and C1 Drugs
➢Import of Schedule-X Drugs
➢Import of small quantities of Drugs for
examination, test or analysis
➢Import of Drugs for personal use.
 IMPORT AND REGISTRATION definition
In this Part.–
(a) “Import licence” means either a licence in Form 10 to import drugs; excluding those
specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X;
(b) “Licensing authority” means the authority appointed by the Central Government to
perform the duties of the licensing authority under these Rules and includes any person to
whom the powers of a licensing authority may be delegated under Rule 22;
(c) “Licence for examination”, “Test or analysis” means a licence in Form 11 to import
small quantities of drugs the import of which is otherwise prohibited, for the purpose of
examination, test or analysis;
(d) “Manufacturer” includes a manufacturer of drugs, who may be a Company or a unit or a
body corporate or any other establishment in a country other than India, having its drugs
manufacturing facilities duly approved by the National Regulatory Authority of that
country, and who also has a free sale approval of the drugs approved by the said authority in
the concerned country, and /or in other major countries;
(e) “Registration Certificate” means a certificate issued under Rule 27A by the licensing
authority in Form 41 for registration of the premises and the drugs manufactured by the
manufacturer meant for import into and use in India.
 Import under license or permit:
Form and manner of application for import licence:
1. An application for an import licence shall be made to the licensing authority in Form 8 for
drugs excluding those specified in Schedule X, and in Form 8-A for drugs specified in
Schedule X.
2. Any application for import licence in Form 8 or Form 8-A, as the case may be
(Emergencies), shall be accompanied by a copy of Registration Certificate issued in Form
41 under Rule 27A: issue an import licence in Form 10 or 10A.
(https://cliniexperts.com/india-regulatory-services/drug/for-importer/import-
license/) & (https://corpbiz.io/learning/cdsco-certificate-for-drugs-import-to-india/)
3. An application for issue of a Registration Certificate shall be made to the licensing
authority in Form 40.
 For point1: Either by the manufacturer himself having a valid wholesale licence, by the
manufacturer‘s agent in India either having a valid licence, and shall be accompanied by a
licence fee of 1000 rupees for a single drug and an additional fee at the rate of 100 rupees
for each additional drug and by an undertaking in Form 9 duly signed by or on behalf
of the manufacturer. For point2: A fee of 250 rupees shall be paid for a duplicate copy of
the licence issued under this Rule, if the original is defaced, damaged or lost.
 For point3: Fee specified in sub-rule (3) of rule 24-A and the information and
undertakings specified in Schedules D-I and D-II duly signed by or on behalf of the
manufacturer.

/
LICENSE FOR IMPORT OF DRUGS MANUFACTURED
BY ONE MANUFACTURE: SINGLE APPLICATION FOR
SINGLE DRUG.

Conditions to be satisfied before a license

is granted :
a) License in Form 10 or in Form 10-A will
be granted with regard to:
i. The premise: where imported substances
are stocked.
ii. The occupation, trade or business
carried out by applicant.
REGISTRATION CERTIFICATE FOR IMPORT OF
DRUGS MANUFACTURED BY ONE MANUFACTURER:
 Single application for single drug Conditions of Import License:
1. Manufacturer will observe the undertakings given by him in Form 9.
2. Inspector authorized by Licensing Authority may enter any premise with
or without notice.
3. The licensee shall furnish specified samples from batch for examination to
the Licensing authority.
4. Licensee shall not sell any batch until a certificate authorizing the sale of
batch has been issued by the authority.
5. The remainder of the batch (REMAINING AFTER SALE) will be
withdrawn if the batch does not confirm with the strength, quality and
purity.
6. The licensee shall maintain a record of all sales of substances of import.
7. For sale and distribution of drugs specified in schedule X, a record
is maintained
i) Name of the drug
ii) Batch number
iii) Name and address of the manufacturer
iv) Date of transaction.
v) Opening stock on business day.
vi) Quantity of drug received, if any and the source
from which received.
vii)Name of the purchaser, his address and license
number.
viii) Balance quantity at the end of the day.
ix) Signature of the person under whose supervision
the drugs have been supplied.
GRANT OF IMPORT LICENSE AND REGISTRATION
CERTIFICATE
1. The licensing authority will issue the Import license in Form
10-A for Schedule X Drugs.
2. Registration certificate in Form 41 on being satisfied that
the conditions will be observed.

Duration of Import License and Registration certificate:

i. Import licence is valid for 3 years unless suspended or cancelled.
ii. Application for Import license be made 3 months before expiry
of existing license
iii. A Registration Certificate, unless, it is sooner suspended or cancelled,
shall be valid for a period of three years from the date of its issue
iv. Registration certificate be made 9 months before expiry of
existing certificate.
Suspension and cancellation of Import
License and Registration certificate:
1. If Licensee fails to comply with any
conditions.
2. Breach of Conditions of License
3. A licensee whose licence has been cancelled
may appeal to the Central Government
within 3 months of the date of the order
Prohibition of Import after loss of potency:
Biological or other special product specified in
Schedule C or C(1) will not be imported after
the expiry date.
Application for License for examination,
test or analysis:
1. Application shall be made in Form 12
2. Countersigned by Head of
institution, Director of the company or
firm
3. Fee of Rs 100 (single drug) + Rs 50
(additional drug)
4. Fees paid through Challan in Bank of
Baroda, New Delhi
 Application for licence to import small quantities
of new drugs by a Government Hospital or
Autonomous Medical Institution for the treatment
of patients:
1. Application under rule 122-E for:
i) Life threatening disease
ii) Disease causing serious permanent disability
2. Application shall be made in Form 12AA.
(https://cdscoonline.gov.in/CDSCO/viewForm
12A)
3. Application in Form 12AA accompanied by fees of Rs 100
(single drug) + Rs 50 (Additional drug)
4. Fees paid through Challan in Bank of Baroda, New Delhi.
APPLICATION FOR IMPORT OF DRUGS FOR PERSONAL
USE:
➢Small quantities of drugs, the import of which is otherwise prohibited
under section 10 of the Act, may be imported for personal use subject
to the following conditions:
1. The drug shall form a part of passenger’s bonafide baggage.
2. The drugs shall be declared to the Customs authorities.
3. The quantity of single drug shall not exceed 100 average
doses/patient.

➢Provided further that any drug, imported for personal use but not
forming part of bona fide personal baggage, may be allowed to be imported
subject to the following conditions, namely
1. Application made in Form 12-A that drug is for bonafide personal
use. (https://cdscoonline.gov.in/CDSCO/viewForm12A)
2. Quantity is reasonable and prescribed by medical practitioner.
3. The license for the said drug is granted in Form 12-B.
 Offences and penalties
1. Any one who imports adulterated or spurious drugs or
cosmetics or cosmetic unsafe for use:
➢Punishable with imprisonment up to 3 years or with fine up to 5000 or both
on first conviction.
➢Punishable with imprisonment up to 5 years or with fine up to 10000 or
both on subsequent conviction.
2. Imports an drugs or cosmetics, the import of which is prohibited
under section 10A (Public interest)/Contravention of the
provision:
➢Punishable with imprisonment up to six months with fine up to 500 or both
on first conviction.
➢Punishable with imprisonment up to 1 year or with fine up to 1000 or both
on subsequent conviction.
❖Section 27 of Drugs and Cosmetics Act: Provides for punishment of
imprisonment for not less than 1 year which may extend to 3 years and fine of
not less than 5000 for manufacture and sale of any adulterated drug.
Important Forms
Forms for Clinical trial for New Drugs
and Clinical Trials Rules 2019
 https://thehealthmaster.com/forms-clinical-trial/
CHAPTER-IV: MANUFACTURE, SALE,
DISTRIBUTION OF DRUGS AND COSMETICS
 MANUFACTURE:
 Manufacture in relation to any drug includes any process or part of a
process for making, altering, finishing, packing, labelling, breaking up or
otherwise treating or adopting any drug with a view to its sale and
distribution.
 But not related to compounding or dispensing of any drug.
 Is a blend of art and science, to be achieved strictly in accordance with the
provisions of Good Manufacturing Practices (GMP).
 A person who is interested in starting manufacturing of drugs is required to
fulfil several conditions laid down in D&CA-1940 and Rules-1945.
 The conditions to be fulfilled before licence is granted are collectively
called as "Conditions Precedent" and conditions that are required to be
fulfilled after the licence is obtained for manufacturing are called
"Conditions Subsequent".
 The Licensing Authority is both in States and at Central Government. The
Central Government is empowered to prohibit manufacturing and
sale of any drug formulation in public interest.
 Before granting license the license issuing authority
send the inspectors who examines:
1) Premises 2) Plant and appliances 3) Process of manufacture
 Means to be employed in standardizing and the substance to be
manufactured.
 Testing facilities for the substance to be manufactured.
 Professional qualification of the technical staff to be employed.
 Report forwarded to the licensing authority by the inspector.
 After complete satisfaction of the provisions a license is issued in a
prescribed form along with a triplicate copy of it (provisions under the
D&C Act 1940).
 Manufacturing License is valid up to 5years from date of grant or
renewal.
 Separate license for manufacturing of drugs at more than one premises.
Hence, a separate application form is needed.
 Application for renewal should be made within 6 months of its
expiry.
 License renewed from time to time.
Different types of LICENSES
Types of licenses granted for the manufacturing of drugs for sale:-
➢Licences are required for the manufacturing of following
categories of drugs.
1. Manufacturing of drugs belonging to Schedules C and
C (I)
2. Manufacturing of drugs belonging to Schedule X
3. Manufacturing of drugs belonging to Schedules C, C
(I) and X
4. Manufacturing of drugs other than Schedule C, C, and
X
5. Manufacturing of drugs for examination, test or
analysis
6. Loan licences
7. Licence for Repacking
 Part XB covers drugs that usually aren't self-administered.
Prohibition of Manufacture
 Drug not of standard quality or
misbranded, adulterated or spurious.
 Patent or proprietary medicine
 Drugs in Schedule-J (a list of diseases
and ailments which a drug may not
claim to prevent or cure)
 Risky to human beings or animals
 Drugs without therapeutic value
 Preparation containing cyclamates
(bladder cancer)
CONDITION FOR GRAND OF LICENCE FOR
MANUFACTURE OF DRUG: (FOR SCH-C,C-I,X OTHER
DRUGS)
 1. Application to be made in prescribed forms with application and inspection fees.
 2. An applicant to obtain drug license must have at least four years of practical experience in
drug distribution.
 3. A drug licensee can only manufacture a drug under the supervision of an experienced
pharmacist.
 4. A drug retailer cannot provide any drug to a minor or a child below 18 years.
 5. Premises, Plant and Equipments shall comply with Schedule M, M1, M2, M3
requirements.
 6. To have sufficient Testing and analytical section headed by an independent competent
person.
 7. Furnish the name of the company, constitution, products to be manufactured and other
details as required by the Authority.
 8. It is forbidden by the law to stock or sells any drug after its expiry.
 9. The medicaments to cure animals must be labelled as “Not for human use, for treating
animals only.”
 10. Drugs that fall under Schedule H or Schedule X classification or have a validity of period
of 2 years.
 Contd..
 11. Adequate staff and laboratory equipments
 12. Proper storage facilities
 13. Valid licence and certificate of renewal
 14. Maintain the record of manufacture and testing
 15. Allow drug inspectors to inspect all the premises
 16. Provide samples of drugs for examination to the Authority
 17. Maintain an “Inspection Book”
 18. Should inform the Authority regarding any changes in the
constitution of the firm or company
 19. Maintain reference samples from each batch of the drugs
manufactured
 20. Keep distribution details
A) License for the manufacture of drug other
than specified in Sch-C,C-I and X.
 Manufacture shall be under supervision of Competent technical staff consisting of
at least one full time employee.
 Application Form 24 with 400 fees and inspection fees-100.
 Grant of licence Form 25 and renew of registration certificate-
Form 26.
 Condition as per the earlier slides.
Who is a competent staff?
a. B.Pharma/ M.Pharma or equivalent qualification with 18 months practice
experience in manfacture of drugs or 1yr if done training in manft of drugs
for 6months during the university course.
b. Graduate in Science with Chemistry as a principle subject and has at least
3yrs prac experience in the manufacture of drugs after his graduation.
c. Graduate in Chem Engg or Chem Techn or Medicine with general training
and practical experience, extending over a period of not less than 3yrs in
the manufacture of drugs, after his graduation.
d. Any foreign qualification which is comparable with those prescribed in
(a), (b) or (c).
For drugs specified in schedule X:
• The licensee shall forward the statements concerning manufacture and supply of drugs to authority after every 3 months.
• application Form 27B
•Fee-400
•Maintain an account registers stipulated under rule 78(n)
•Drugs are not for “Physicians samples”
•Condition as per the earlier conditions.
For drugs specified In schedule C, C1(excluding X and XB:
➢Sch-C drugs must be issued in sterilized bacteria proof glass containers only.
➢Drugs must comply with Strength, quality and purity as specified in Sch-F and Sch-F1
➢Parenterals must be free from pyrogens
➢Application form-27 with fees-600 and inspection fee-400.
➢Drugs licence specified in Sch C,C1,X and XB other than LVP, sera, vaccines ………..Form 28
➢Sch C,C1,X other than lVP, sera and vaccines …………….Form 28B
➢LVP, sera and vaccines ………… Form 28D

For manufacture of drugs meant for Test, Examination and Analysis:

1. The licence required separately
2. Test and analysis purpose are exempted from the provision of section 18 of the DCA,1940.
3. A separate licence in Form 29 to be obtained with fees-15
4. The licence is valid for one year
5. Highlight the name of the drugs on the level and its uses
Accounts for the drugs specified for Sch-X used for
manufacture:
 Loan Licence:
 Loan Licence is a condition in which the persons who do not have their own
manufacturing facilities, but wish to utilise the facilities existing with another person
licensed to manufactured drugs, such licences are called “Loan Licences”.
 A loan license means a license which a licensing authority may issue to an applicant
who doesn’t have its own arrangement of manufacturing.
 Renting a whole plant and its machinery
 Procedure allowed to encourage more production of drugs with less expenditure.
 Application for grant of the licence shall be supported by documentary approval of
the licence whose facilities are to be availed for the manufacture.
 If the conditions fulfilled, the loan licence is issued in prescribed Form 25A &
Form 28A.
Two types of Loan Licence are issued/approved for:
1. All drugs other than those specified in Sch-C,C1 and X.
2. The other for the drugs specified in Sch-C nad C1.
*There is no provision for manufacture of Sch-X Drugs under Loan
Licence.
 Criteria to get the Loan Licence
❖ Application for loan licence shall be made in the prescribed Forms 24A or
27A with rupees 200 or rupees 600 respectively.
❖ Applicants have to submit consent letter/Cover Letter
❖ Applicant must satisfy conditions relating to licence under the Act and Rules.
❖ Licence holder should possess the necessary equipments/Manufacturing
facilities, staffs, etc.
❖ If the person whose facilities are being utilized and the person licence is
cancelled, or suspended the loan licence will also be deemed cancelled.
❖ The licensee shall test all the batches, raw materials, final products and
maintain the records as per the schedule for a period of 5 years from the
date of manufacture.
❖ The licensee shall allow the inspector to inspect all registers, records,
premises, manufacturing units/working processes, etc.
❖ The licensee shall maintain control sample for each batch/Inspection Book.
❖ The licensee must have the corresponding wholesale distribution licence.
Repacking license
Chapter-III: Manufacture of
Cosmetics/ The Drug and Cosmetic act
1940 and rules 1945
Prohibition of Manufacture
 Drug not of standard quality or misbranded, adulterated
or spurious.
 Risky to human beings or animals
 Cosmetics containing Hexachlorophene or mercury
compounds
 Cosmetics containing colour which contain more than -
2ppm of arsenic, 20 ppm of lead, 100 ppm of heavy metals.
 Eye preparations containing coal-tar colour
List of Cosmetics: Skin powder, Skin powder for
infants, tooth powder, tooth paste, skin cream, hair
oils, shampoo-soap-based. Shampoo-synthetic
detergent based, hair cream, Skin protectants, lipstick,
lotions, deodorant soaps, etc.
 Regulatory provision related to
manufacture of Cosmetics
 A license is required for the manufacture of cosmetic for
sale/distribution.
 This license is issued by the state regulatory authorities (State Food
and drugs administration).
 How to obtain license: Application is required to made in form
no 31. The application should accompanied by a fee of Rs.2500 and
inspection fee of Rs. 1000.
 Grant of license issued in form no 32.
 The application is accompanied with following documents.
1. Layout plan of the factory premises
2. A list of equipment and machinery to be installed.
3. A document showing the constitution of the firm.
4. A document showing the possession of applicant on the proposed
premises for factory e.g. rent receipt.
5. The categories of cosmetics have been specified under schedule-
M-II to the rules.
 Contd..
 Usually the application forms are got printed by the state
Drugs Control Deptt./FDA and are available from their
office.
 Before grant of licence, the factory premises are inspected by
the officer (s) of the State regulatory agency.
 OFFENCES/PENALTIES:
OFFENCES PENALTIES
MANUFATURE/STOCK/SALE/DISTRUBUT 3 YEAR IMPRISONMENT & FINE.
ION OF SPURIOUS/MISBRANDED/NOT
OF QUALITY STANDARD COSMETICS
MANUFATURE/STOCK/SALE/DISTRUBUT 1 YEAR IMPRISONMENT & FINE-1000 OR
ION OF SPURIOUS/MISBRANDED/NOT BOTH
OF QUALITY STANDARD WHICH CAN
RENDER UNSAFE/HARMFUL FOR USES
CONTRAVENTION OF THE PROVISION OF 1 YEAR IMPRISONMENT & FINE-2000 OR
CHAPTER-IV OF THE ACT AND RULES BOTH
 Sale of Drugs
Contents
SL. Topics
No
1. Classes of drugs prohibited to be sold
2. Wholesale of biological (C/CI) Drugs
3. Wholesale of other than those specified in C/CI
and X
4. Wholesale of Sch-X Drugs
5. Retail sale
➢General licence
➢Restricted licence
 1. Classes of drugs prohibited to be
sold
 Misbranded, adulterated or spurious and drugs
not of standard quality
 Risky to human beings or animals
 Patent/proprietary drugs with undisclosed
formula
 Sch-J drugs
 Expired drugs
 Drugs used for consumption by government
scheme such as E.S.I.S, Armed force.
 Physician’s samples
 Drugs manufactured/imported in
contravention of the provision of the Act.
2. Wholesale of biological (C/CI) Drugs
 Conditions:
 The licence must have adequate premises, equipped with facilities for
storage
 Requirement prescribed to run pharmacy as per Sch-N
 All register &record should be preserved for 2 years
 Licensee must allow an inspector to inspect the premises, register &
records.
 If any changes in qualified staff, report to the licensing authority
 Precaution should be taken for the storage of Sch-C/CI Drugs
 The licence should be displayed at prominent place
 Maintain the inspection Book.
 Drugs should be purchase from the license manufacturer
 Do not stock & sell expired drugs
 No physician’s samples and Govt. scheme drugs
 Veterinary products are stored separately and labelled “NOT FOR
Restricted Licence

 Application form 20A

 Under Form 21A, this licence is issued to those applicants who want to sell
drugs without the supervision of a competent individual.
 For the far/restricted places
Some important forms to issue the
licence for sale, stock, distribute the
drugs
Labelling & Packaging
Labelling