The document summarizes the administration of the Drugs and Cosmetics Act in India. It is organized into three sections - Advisory, Analytical, and Executive. The Advisory section includes the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC) which advise the government. The Analytical section covers the Central Drugs Laboratory, state drug control laboratories, and role of Government Analysts in testing samples. The Executive section discusses the roles and responsibilities of Licensing Authorities, Controlling Authorities, and Drug Inspectors in enforcing the act.

1. Program : Pharmacy (D. Pharmacy)
Class : Second Year
Course : Pharmaceutical Jurisprudence
Unit : Administration of the D & C
Lecture 07 : Dr. Amar Gangadhar Zalte
Associate Professor
M. Pharm. (Quality Assurance Techniques),
Ph. D. (Pharmaceutical Sciences),
M. B. A (Project Management)
SCHOOL OF PHARMACEUTICAL SCIENCES

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Code of Pharmaceutical Ethics
Administration of the act and rules
Analytical
Executive
Advisory

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Administration of the D & C act
A) Advisory:
1)Drugs Technical Advisory Board- DTAB
2)Drugs Consultative Committee- D.C.C.
B) Analytical:
1)Central Drugs Laboratory - CDL
2)Drug Control Laboratory in states
3)Government Analysts

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Administration of the D & C act
C) Executives:
1)Licensing authorities
2)Controlling authorities
3)Drug Inspectors

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Advisory
1. Drugs Technical Advisory Board (DTAB)
Ex-Officio:
(i) Director General of Health Services (Chairman)
(ii) Drugs Controller, India
(iii) Director of the Central Drugs Laboratory, Calcutta
(iv) Director of the Central Research Institute, Kasauli
(v) Director of Indian Veterinary Research Institute, Izatnagar

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Advisory
(vi) President of Medical Council of India
(vii) President of the Pharmacy Council of India
(viii) Director of Central Drug Research Institute, Lucknow
 Nominated:
1) Two persons by the Central Government.
2) One person by the Central Government from the pharmaceutical industry
3) Two persons holding the appointment of Government Analyst under this
Act.

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Advisory
Elected:
1) One person, to be elected by the Executive Committee of the Pharmacy Council of
India
2) One person, to be elected by the Executive Committee of the Medical Council of
India
3) One pharmacologist to be elected by the Governing Body of the Indian Council
of Medical Research
4) One person to be elected by the Central Council of the Indian Medical Association
5) One person to be elected by the Council of the Indian Pharmaceutical Association

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Advisory
Functions of DTAB:
To advise the Central Government and the State Governments on
technical matters.
To carry out the other functions assigned to it by this Act.

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Advisory
2. Drugs Consultative Committee (DCC)
• It is also an advisory body constituted by central government.
• Constitution:
• Two representatives of the Central Government
• One representative of each State Government

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Advisory
Functions:
• 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.
• The Drugs Consultative Committee shall meet when required
• Has power to regulate its own procedure.

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Analytical
1. Central Drug Laboratory(CDL)
• Established in Calcutta, under the control of a director appointed by the Central
Government.
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 standards and their maintenance.

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Analytical
• Maintenance of microbial cultures.
• Any other duties entrusted by Central Government.
• Acting as an appellate authority in matter of disputes.

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Analytical
2. Drug control laboratories in state
• In Gujarat, three laboratories established which collect, analyzed and
report the various sample of the drugs and food.
1) Baroda: Established in 1959.
2) Bhuj: Established in 1979.
3) Rajkot: Established in 1983

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Analytical
The laboratory has the following division:-
• Pharmaceutical Chemistry Division
• Immunology Division
• Pharmacology Division
• Pharmacognosy Division
• Food Division
• Ayurvedic Division

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Analytical
Functions:
Testing of drug sample
Analysis of food sample
Analysis of excise sample

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Analytical
3. Government analyst
• These officers are appointed by the central or state government and perform the
duties.
• Qualification of government analyst
• 1 Persons having qualification for appointment as government as governmental
Analysis for allopathic drugs;
• 2 having a degree in medicine, ayurved, sidha or unani system and not less than
three year post graduate experience in the analysis of drugs in a laboratory under
control of a government analyst.

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Analytical
Duties:
• The Government Analyst shall cause to be analyzed or tested such
samples or drugs and cosmetics as may be sent to him by Inspectors.
• A Government Analyst shall from time to time forward reports to the
Government giving the result of analytical work and research with a
view to their publication.

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Executive
1. Licensing authority
• Qualification:
(i) Graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine
with specialization in clinical pharmacology or microbiology from a
University established in India by law; and
(ii)Experience in the manufacture or testing of drugs a minimum period
of five years

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Executive
Duties:
(1) To inspect all establishments licensed for the sale of drugs within the area assigned
to him;
(2) To satisfy himself that the conditions of the licences are being observed;
(3) To procure and send for test or analysis, if necessary, imported packages.
(4) To investigate any complaint.
(5) To maintain a record of all inspections made and action taken by him in the
performance of his duties,
(6) To make such enquiries and inspections as may be necessary to detect the sale of
drugs in contravention to the Act;

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Executive
2. Controlling authority
Qualification:
• Graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine
with specialization in clinical
• Pharmacology or microbiology from a University established in India
by law and
• Experience in the manufacture or testing of drugs or enforcement of
the provisions of the Act for a minimum period of five years

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Executive
4. Drug Inspector
Qualification
1 Persons having qualification for appointment as government as governmental
Analysis for allopathic drugs; or
2 Having a degree in ayurveda, siddha or unani system and not less than three year
post graduate experience in the analysis of drugs in a laboratory under control of
(a) A government analyst, or
(b) A chemical examiner, or
(c) Head of an institution specially approved for this purpose.

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Executive
Power:
A) Inspect:
(i) Any premises where in any drug or cosmetic is being manufactured.
(ii) Any premises where in any drug or cosmetic is being sold, or
stocked or exhibited or offered for sale, or
distributed ;

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Executive
Power:
(B) Take samples of any drug or cosmetic:
(i) Which is being manufactured or being sold or is stocked or exhibited
or offered for sale, or is being distributed;
(ii) 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.

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