Administration of the D & C Act, 1940

ADMINISTRATION OF
THE
DRUGS & COSMETICS
ACT, 1940
1

Mr. Shaktiprasad Pradhan
M.Pharm, Ph.D*
Research Professional, UDPS
shakti.pharma16@gmail.com
Utkal University, Bhubaneswar
Odisha, India 2

THE DRUGS & COSMETICS ACT, 1940
The modern medicines have been imported by India till
after the first word war which made India mostly
dependent.
In August 1930, the Government of India, under the
Chairmanship of R.N. Chopra appointed a Drug Enquiry
Committee for the quality & standard of drugs sold and
recommendation for control measure.
In 1937, a bill was introduced to give effect to the
recommendations of the Drugs Enquiry Committee in the
Central Legislative Assembly for a more comprehensive
measure for the uniform control of import, manufacture,
distribution and sale of drugs was desirable.
In 1939, the Drug Import Bill was prepared & placed for
consideration before the Central Legislative Assembly.
In 10th April, 1940 the bill was passed & received assent
of the Governor General in Council & became the Drugs and
Cosmetics Act, 1940.
In 1945, the related Drugs Rules of the D & C Act, 1940
were passed. 4

.
OBJECTIVES & ROLE
OF THE
D & C ACT, 1940
5

Objectives of the D & C Act, 1940
The Act visualizes the regulatory control over the
drugs imported in to the country by the Central
Government while the manufacture, sale and
distribution of drugs is primarily regulated by the
State Drug Control Authorities appointed by the
respective State Governments.
The primary objective of the Act is to ensure that
the drugs & cosmetics sold in India are safe, effective
and conform to state quality standards and to make
available Standard Quality drug/ cosmetic to
consumer.
The manufacture and sale of the drugs is regulated
through a system of licensing and inspection by the
Licensing Authorities. (Cont.) 6

The Central Drugs Standard Control Organization
(CDSCO), headed by the Drugs Controller General,
India (DCGI) is concerned with the regulatory control
over the quality of drugs & cosmetics.
Role of the D & C Act, 1940
To prevent substandard in drugs & maintaining
high standards of medical care.
To regulate the import, manufacture, distribution
and sale of drugs & cosmetics through licensing.
To regulate the manufacture and sale of Ayurvedic,
Siddha and Unani drugs.
To establish Drugs Technical Advisory Board
(DTAB) and Drugs Consultative Committees (DCC)
for Allopathic and allied drugs & cosmetics. 7

.
AMENDMENTS
IN THE
D & C ACT, 1940
8

Amendments in the Act and adaptation of Orders
1. The Repealing and Amending Act, 1949 (40 of 1949)
2. The Adoption of Laws Order, 1950
3. The part B States (Laws) Act, 1951 (3 of 1951)
4. The Drugs (Amendment) Act, 1955 (11 of 1955)
7. The Drugs and Cosmetics (Amendment) Act, 1964
16. The Drugs and Cosmetics (Amendment) Act, 2016 9

.
CHAPTERS IN THE
D & C ACT, 1940
10

Chapters in the D & C Act, 1940
Chapter I- Introduction.
Short title, extent and commencement and definitions.
Chapter II- Various Administrative Agencies.
The Drugs Technical Advisory Board, the Central Drugs
Laboratory and the Drugs Consultative Committee and
its constitution.
Chapter III- Import of Drugs and Cosmetics.
Standards of quality, Misbranded drugs, Adulterated
drugs, Spurious drugs & Cosmetics and prohibition of
import of certain drugs or cosmetics.
(Cont.)
11

Chapter IV- Manufacture, Sale and Distribution of Drugs
& Cosmetics.
Standards of quality, Misbranded drugs, Adulterated drugs,
Spurious drugs & Cosmetics and prohibition of
manufacture, sale and distribution of certain drugs or
cosmetics.
Chapter IV(A)- Provisions relating to Ayurvedic, Siddha
& Unani drugs.
Chapter V- Miscellaneous.
Power to give directions, offences by companies,
Government departments, penalties and sentences passed
under this Act, Magistrate’s power to impose enhanced
penalties, etc.
12

.
ADMINISTRATION OF
THE
D & C ACT, 1940
13

Administration of the D & C Act, 1940
The D & C Act, 1940 provides for the establishment of
various administrative bodies for the smooth
administration of the Act through out the country.
Advisory
Drugs Technical Advisory Board (DTAB)
Drugs Consultative Committee (DCC)
Analytical
Central Drugs Laboratory
State Drugs Control Laboratories
Government Analysts
Executive
Licensing & Controlling Authorities
Drug Inspectors
Customs Collectors
(Cont.) 14

Drugs Technical Advisory Board (DTAB)
DTAB is the highest statutory decision making body on
technical matters related to drugs in India.
It is a part of the Central Drugs Standard Control
Organization (CDSCO) in the Ministry of Health & Family
Welfare, Govt. of India.
DTAB is constituted under Section-5 of the D & C Act, 1940
by the Central Government to advise both the Central as well
the State Governments on technical matters arising out of the
administrations.
It consists of total 18 members of whom, 8 are ex-officio, 5
nominated and 5 elected members.
Both the nominated and elected members hold the office for
three years but are eligible for re-nomination and re-election.
The Central Government appoints the Secretary and
provides the clerical & other staff to the board. (Cont.)
15

The board may appoint sub-committees and may
appoint persons who are not board members either
temporarily or for some period not exceeding 3 years.
Ex-officio Members (8 No.)
1. Director General of Health Services, India (DGHS)
[CHAIRMAN]
2. Drugs Controller of India (DCGI) [MEMBER SECRETARY]
3. Director, Central Drugs Laboratory, Kolkata (CDL)
4. Director, Central Research Institute, Kasauli (CRI)
5. Director, Indian Veterinary Research Institute, Izatnagar
(IVRI)
6. Director, Central Drug Research Institute, Lucknow (CDRI)
7. President, Pharmacy Council of India (PCI)
8. President, Medical Council of India (MCI)
(Cont.)
16

Nominated Members (5 No.)
1. One person nominated from Pharmaceutical Industry by
the Central Government.
2. Two persons from amongst persons who are in charge of
drugs control in states nominated by the Central
Government.
3. Two Government Analysts, nominated by the Central
Government.
Elected Members (5 No.)
1. A teacher in Pharmacy or Pharmaceutical Chemistry or
Pharmacognosy on the staff of an Indian University or
affiliated College, elected by the Executive Committee of
Pharmacy Council of India (PCI).
2. A teacher in Medicine or Therapeutics, on the staff of an
Indian University or affiliated College, elected by the
Executive Committee of Medical Council of India (MCI).
17

3. One person, elected by the Council of Indian Pharmaceutical
Association (IPA).
4. One person, elected by the Council of Indian Medical
Association (IMA).
5. One Pharmacologist, elected by the Governing body of the
Indian Council of Medical Research (ICMR).
Drugs Consultative Committee (DCC)
The Central Govt. may constitute an advisory committee to
be called the Drugs Consultative Committee (DCC) to advise
the Central Govt., the State Govt. & the DTAB on any matter
tending to secure uniformity throughout the country in the
administration of the D & C Act, 1940.
The DCC shall consist of 2 nominated representatives of the
Central Govt. & 1 nominated representative of each State
Govt..
The DCC shall meet when required to do so by the Central
Govt. & shall have power to regulate its own procedure. 18

 Central Drugs Laboratory (CDL)
The Central Drugs Laboratory is the national statutory
laboratory of the Indian Central Govt. for quality control of
Drugs & Cosmetics.
It is the oldest quality control laboratory of the Drug Control
Administration in India, established in Kolkata under the D &
C Act, 1940.
It functions under the administrative control of the Director
General of Health Services (DGHS), Ministry of H & FW, Govt.
of India.
The Central Drugs Laboratory is entrusted with the
following functions:
I. To analyze or test samples of drugs or cosmetics sent to it under
sub-section (2) of section 11, or under sub-section (4) of section 25 of
the Act, by the Customs Collectors or Courts.
II. To carry out such other duties as may be entrusted to it by the
Central Govt. or by the State Govts. with the permission of the
Central Govt. and in consultation with DTAB. (Cont.) 19

Biological & microbiological tests or analysis are not
carried out in the Central Drugs Laboratory at Kolkata.
Hence the samples are required to be sent to the Directors
of different research institutes & laboratories who exercise
all the functions of the Director, Central Drugs Laboratory,
in respect of such classes of drugs.
Tests or analysis of the samples of sera, vaccines, toxins,
antigens, antitoxins, sterilized surgical ligatures & sutures,
bacteriophages, solutions of serum proteins for injection etc.
are carried out at the Central Research Institute, Kasauli.
Tests or analysis of the samples of antisera, vaccines,
toxoids & diagnostic antigens all for veterinary use are
carried out at the Veterinary Research Institute, Izatnagar
or Mukteshwar.
Tests or analysis on the samples of condoms are carried
out at the Central Pharmacopoeial Laboratory, Ghaziabad.
(Cont.)
20

Tests or analysis on the samples of Intra-uterine devices &
Falope rings are carried out at the Central Drug Testing
Laboratory, Thane.
Tests or analysis on the samples of VDRL antigens are
carried out at the Laboratory of the Serologist & Chemical
Examiner to the Govt. of India, Kolkata.
Tests or analysis on the samples of Oral Polio Vaccines are
carried out at the Pasteur Institute of India, Coonoor &
Enterovirus Research Centre, Mumbai.
Tests or analysis on the samples of various diagnostic kits
(HIV kit, Hepatitis-B & C kit, Glucose test strips,
Biochemical kits, Fibrin Sealant kit etc.) are carried at the
National Institute of Biologicals, Noida.
Tests or analysis on the samples of all homeopathic
medicines are carried out at the Homeopathic
Pharmacopoeial Laboratory, Ghaziabad. (Cont.)
21

Tests or analysis on the samples of human blood & its
products including components, to test for freedom of HIV
antibodies, are carried out at
•National Institute for Communicable Disease, Dept. of Microbiology,
New Delhi.
•National Institute of Virology, Pune.
•Centre of Advance Research in Virology, Christian Medical College,
Vellore.
State Drugs Control Laboratories (SDCL)
As per the D & C Act, 1940 each of the states of India is
required to establish a laboratory for the analysis & testing of
drugs and cosmetics manufactured or sold within the State
concerned.
Samples taken by the Drug Inspectors during the course of
inspection of the licensed manufacturing houses & retail
establishments are required to be analysed in these
laboratories for ascertaining whether they come up to the
prescribed standards or not. (Cont.)
22

Qualifications of Govt. Analysts
A graduate in Medicine/Science/Pharmacy/Pharmaceutical
Chemistry of recognized University and have at least 5
years of experience or a postgraduate in the above areas
with at least 3 years of experience in testing of drugs in a
laboratory under the control of
I. A Government Analyst, or
II. Head of an approved institution or testing laboratory.
Duties of Govt. Analysts
Analyze and test samples of drugs or cosmetics sent to
him by the Drug Inspectors or other persons under the Act
and to furnish reports of the results of test or analysis.
Engage in any possible research work & forward to their
respective Government from time to time, results of
analytical & research work with a view to publication at the
discretion of the Government. 23

Procedure of Govt. Analysts
On receipt of package of sample from an Inspector the
Government Analyst should compare the seals on the
package with the specimen seals and note its condition.
On completion of test or analysis, the report in triplicate
together with full protocols of the tests or analysis should be
sent to the Investigator.
Government Analyst has to submit a report in form-1 and
unless full protocols are supplied, the report cannot be
regarded as conclusive evidence.
Reports signed by Govt. Analysts are taken to be
evidences of the facts stated theirin unless they are
challenged within 28 days.
In case of a challenge, the samples may be sent for test or
analysis to the Central Drugs Laboratory whose report shall
be deemed to be exclusive. 24

Licensing & Controlling Authorities (LA & CA)
Authorities are appointed by the Central Govt. to issue
licences for the import of drugs.
The State Governments appoint Licensing Authorities &
Controlling Authorities for their respective States to issue
licences for the manufacture & sale of drugs and for
manufacture of cosmetics.
The requisite qualification for the Licensing Authority &
Controlling Authority is indicated under 49A & 50A
respectively through the 9th amendment to the D & C Rules,
in1989.
The Licensing Authorities are empowered to issue or refuse
to issue licences to prospective applicants, also to cancel or
suspend the licences issued by them if there is any kind of
contravention of the Act or Rules their under.
However their decision can be challenged in the courts of
law. (Cont.)
25

The Licensing & Controlling Authorities are designated as
differently in different states, mostly Drug Controller along
with Director, Drug Control Administration, Office-in-
charge, Drug Control etc in some states.
Drug Inspectors (DI)
All Drug Inspectors are public servants under the Section-
21 of the Indian Penal Code (IPC) & work under the Drug
Controlling Authority under State Govt. or Central Govt.
The Inspectors may be appointed either to inspect licensed
premises for sale of drugs or to inspect the establishments
licensed for the manufacture of both drug & cosmetics.
Inspectors are required to keep all information acquired
by them, in the course of their duty, confidential & not
disclose it except for official purposes or when required to do
before the court of law.
(Cont.) 26

No persons having any financial interest in the import or
manufacture or sale of drugs & cosmetics can be appointed as
Drug Inspector under the Act.
Qualifications of Drug Inspectors
For appointment as Drug Inspector, a person must have a
degree in Pharmacy/ Pharmaceutical Chemistry/Medicine with
specialization in Clinical Pharmacology/Microbiology from a
recognized University.
For inspection of manufacture of substances in Schedule-C,
the DI must have:
I. At least 18 months experience in manufacture of at
least one of the substance specified in the Schedule-C.
II. At least 18 months experience in testing one of the item
in the schedule-C.
III. Experience of not less than 3 years in inspection of
firms manufacturing any of the substances of the
Schedule-C during their service tenure as DI. 27

Powers of Drug Inspectors
Can inspect any premises wherein any drug or cosmetic is
being manufactured and the means employed for
standardizing and testing the drug or cosmetic.
Can inspect any premises wherein any drug or cosmetic is
being sold or stocked or exhibited or offered for sale, or
distributed.
Take samples of any drug or cosmetic which is being
manufactured or being sold or is stocked or exhibited or offered
for sale or is being distributed.
Take samples from any person who is in the course of
conveying, delivering or preparing to deliver such drug or
cosmetic to a purchaser or a consignee.
At all reasonable times with necessary assistance, search
any person, who has secreted about any drug or cosmetic in
respect of which an offence relating to manufacture, sale or
distribution has been or is being committed. (Cont.) 28

Can enter and search any place in which he has reason to
believe an offence relating to manufacture, sale or
distribution of drugs or cosmetics has been, or is being
committed.
Can stop and search any vehicle, vessel, or other
conveyance which, he has reason to believe, is being used
for carrying any drug or cosmetic in respect of which an
offence has been, or is being, committed, and order in
writing the person in possession of the drug or cosmetic not
to dispose of any stock that of for a specified period not
exceeding 20 days or, unless the alleged offence is such that
the defect may be removed by the possessor of the drug or
cosmetic, seize the stock of such drug or cosmetic and any
substance or article by means of which the offence has been
or is being, committed.
(Cont.)
29

Can examine any record, register, document or any other
material object with any person or in any place mentioned
above and seize the same if it is likely to furnish the
evidence as an offence.
Can require any person to produce any record, register, or
other document relating to the manufacture for sale or for
distribution of any drug or cosmetic in respect to which an
offence has been committed exercise such other powers as
may be necessary for carrying out the purposes of the Acts
or Rules.
Duties of Drug Inspectors
Inspection of premises licensed for sale
Inspect not less than twice in a year all establishments
licensed for sale of drugs within the area assigned to the
Drug Inspector and to e satisfied that the conditions of
license are being observed. (Cont.)30

Procure and send for tests or analysis, if the Drug Inspector
has reason to think that the drugs are sold in contravention
of provisions of the Acts or Rules.
To investigate any complaints made to the Drug Inspector
in writing & to institute prosecutions in respect to the
contravention of the Act or Rules.
To institute legal proceedings in case of any breach of the
Act or the Rules.
To maintain all records of inspections made & actions taken
by him/her including taking of samples and seizure of stocks
& to submit copies of such records to the Controlling
Authority.
To make enquiries and inspections as may be necessary to
detect sale of drugs in contravention to the Act or Rules.
When so authorized by the State Governments to obtain
imported packages to suspect for containing drugs whose
import is prohibited under the Act or Rules. 31

Inspection of Manufacture of Drugs
Inspect not less than twice in a year all premises licensed
for the manufacture of drugs within the area allotted to the
Drug Inspector and to be satisfied that the condition of
license and provisions of Acts and Rules are observed.
In establishments licensed to manufacture products
specifies in Schedule C and C1 inspect the process of
manufacture, means employed for standardizing and testing
of drugs, methods & place of storage, technical
qualifications of staff employed & all details of location,
construction & administration of establishment likely to
affect the potency or purity of drug.
To send Controlling Authority after each inspection a
detailed report indicating conditions of license & provisions
of Acts & Rules which are being observed & which are being
not observed. (Cont.)
32

To take samples of drugs manufactured on premises &
send them for test or analysis.
To institute prosecutions in respect of breaches of the Act
or Rules.
Procedure of Drug Inspectors
For taking samples of drugs & their despatches to the Govt Analysts
An Inspector taking any samples must pay its fair price & may
require written acknowledgement for the same. If price tendered is
refused or when Inspector seizes any stock of any drug or cosmetic,
he/ she should issue the receipt for the same.
The Drug Inspector should inform the concerned person, the
purpose of taking the sample & divide the sample to four parts in his
presence. Each portion is then sealed & suitably marked. The person
from whom the sample is taken must also be allowed to add his
mark of seal on the packet. If sample taken from a manufacturing
premises, it should be divided to three portions only. (Cont.) 33

If the sample is made into small volume is likely to
deteriorate, the Drugs Inspector can take three or more
containers when necessary after suitably marking it.
One portion of sample is to be restored to the person, second
part send to Government analyst and third one is preserved
for production before the court, if required & fourth is sent to
warrantor if any.
Inspector should send sample to Government Analyst for the
purpose of analysis of seized materials by registered post or by
hand in sealed packet enclosed together with memorandum.
If the confiscated drug is not of standard quality, it should be
reported to court accordingly & court may order destruction of
drug under the supervision of the Drug Inspector in presence
of such authority that the court may prescribe.
If confiscated drug is of standard quality, the Drug Inspector
may report court accordingly and court may order sale of drugs
by public auction to any party holding a requisite license. 34

For entry & search etc. of places, persons, vehicles, vessels etc.
Every person for time being in charge of any premises where
any drug or cosmetic is manufactured or is kept for sale or
distribution, on being required by the Drug Inspector is legally
bound to disclose to the inspector the place where drug or
cosmetic is being manufactured or kept.
Wilfully obstructing the Drug Inspector or refusing to
provide any record or register is punishable with
imprisonment up to three years or with fine or both.
Forms or Memorandums used by the Drug Inspectors
Form 15: Order given by the Inspectors requiring a person not to dispose of
any stock in his possession.
Form 16: Receipt by the Inspectors tender fair price for the seized material.
Form 17: Intimation to the person from whom sample is taken & purpose of
taking sample.
Form 17-A: Receipt of samples of drugs/cosmetics taken where fair price is
tendered.
Form 18: Memorandum sent to the Govt. Analyst for the purpose of analysis of
seized materials. 35

For seizure of stocks
Any record, register or any other document seized by the
Drug Inspector should be returned to the persons from
whom they were seized or who produce the same within a
period of 20 days of such seizure or produce after making
copies, extracts etc. if necessary.
When the Drug Inspector seizes any record, register or
document, or any other material object, he should as soon as
inform the same to the judicial magistrate & take his orders
to the custody thereof.
Customs Collectors (CC)
The Custom Collectors are authorities established under
laws other than the D & C Act, 1940 but they are charged with
the administration of the D & C Act, 1940 to a certain extent.
They are assigned some functions relating to control over
the, import of drugs.
36

References
 History of D&C Act, 1940.
 http://www.medindia.net/indian_health_act/drugs-and-
cosmetics-act-1940 introduction.htm
 Drugs and Cosmetics Act, 1940.
https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Act,_19
40#Amendments
 Drugs and Cosmetics Rules, 1945.
https://en.wikipedia.org/wiki/Drugs_and_Cosmetics_Rules,_
1945
 Ministry of Health and Family Welfare, GSR 588 (E) dated
30 Aug, 2013.
 Ministry of Health and Family Welfare, GSR 103 (E) dated
02nd February, 2017.
 Dr. B. S. Kuchekar. Pharmaceutical Jurisprudence. Pragati
Books Pvt. Ltd. P.P 5.0–5.2.
 B. M. Mithal. A Text Book of Forensic Pharmacy. Vallabh
Prakashan. 114-123. 38

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