Drugs and Cosmetics Act
Content
• Definitions
• Administration of the act and rules
• Provisions related to Import
• Provisions related to Manufacture
• Provisions related to Sale
• Labeling and Packaging
• Schedules to the act and rules
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Intended Learning Objectives
• At the end of this lecture, student will be able to
– Discuss the Provisions of DTAB and DCC
– Discuss the Provisions Govt. Analyst and Central Drugs Laboratory
– Discuss the Provisions related to Licensing and Controlling Authority
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Drugs Technical Advisory Board (DTAB)
Ex-Officio Members:
(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
(vi) President of Medical Council of India
(vii) President of the Pharmacy Council of India
(viii)Director of Central Drug Research Institute, Lucknow
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Drugs Technical Advisory Board (DTAB)
Nominated Members:
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
Elected Members:
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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Drugs Technical Advisory Board (DTAB)
Functions:
• 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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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
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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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
• Maintenance of microbial cultures
• Any other duties entrusted by Central Government
• Acting as an appellate authority in matter of disputes
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The Central Drugs Laboratory
• Provides for the establishment of a Central Drugs Laboratory under the control
of a director appointed by Central Government
• The Laboratory established in Calcutta has been entrusted with the following
functions
1) to analyze or test samples of drugs or cosmetics sent to it by the cosmetics
collectors or courts
2) to carry out such other duties entrusted to it by the Central Government or
with its permission, by State Governments, after consultation with DTAB
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The Central Drugs Laboratory
• The Central Research Institute, Kasauli carries out functions in respect of sera,
solutions of serum, proteins for injections, vaccines, toxins, antigens, antitoxins,
sterilized surgical ligatures and sutures and Bacteriophages
• Vetenary Research Institute, Izantnagar and Mukteshwar carries out functions
in respect of antisera, vaccines, toxoids & diagnostic antigens, all for Vetenary
Use
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Drug Control Laboratories in State
In Karnataka three laboratories established which collect, analyze and report the
various sample of the drugs and food
The laboratory has the following divisions:-
• Pharmaceutical Chemistry Division
• Pharmacology Division
• Pharmacognosy Division
• Food Division
• Ayurvedic Division
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Drug Control Laboratories in State
Functions:
• Testing of drug sample
• Analysis of food sample
• Analysis of excise sample
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Government analyst
These officers are appointed by the central or state government and perform the
duties
Qualification of Government Analyst
• Persons having qualification for appointment as governmental analyst for
allopathic drugs ; having a degree in medicine, 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 government analyst
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Government analyst
Duties:
• The Government Analyst shall cause to be analysed 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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Government Analysts
• State Government by notification in the Official Gazette, appoint persons having
sufficient qualifications to be government Analysts for such areas in state & in
respect of such drugs and classes
• Central Government may also similarly appoint Government Analysts in respect
of such drugs or classes of drugs or cosmetics as specified
• No person having any interest in the import, manufacture or sale of drugs or
cosmetics or is directly or indirectly engaged in any trade or business connected
with manufacture of drugs can be appointed as Government analysts
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Qualifications
A graduate in medicine/science/pharmacy/pharmaceutical chemistry of recognized University and have
5 yrs post graduate experience in testing of drugs in a laboratory under the control of 1)a Government
Analyst or 2) head of approved Institution or testing laboratory.
A Post Graduate in medicine/science/pharmacy/pharmaceutical chemistry of recognized University with
at least 3 years of experience in the testing of drugs in a laboratory under the control of 1)a Government
Analyst or 2) head of approved Institution or testing laboratory.
Duties of Government Analyst
Analyze or test samples of drugs/cosmetics sent to him by inspectors or other persons under the act
and to furnish reports of the results of test or analysis.
Forward to Government from time to time, reports giving the results of analysis works and research
with a view to their publication at the discretion of Government.
Procedure
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, reports 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.
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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,
Provided that the requirements as to the academic qualification shall not apply to
those inspectors
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 licenses are being observed;
(3) to procure and send for test or analysis, if necessary, imported packages.
(4) to investigate any complaint.
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(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;
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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Summary
➢DTAB advises the Central Government and the State Governments on technical matters.
➢To carry out the other functions assigned to it by this Act
➢ CDL Established in Calcutta, under the control of a director appointed by the Central
Government
➢DCC is an advisory body constituted by central government
➢ Govt. Analysts are officers appointed by the central or state government and perform the
duties
➢Licensing Authority inspect all establishments licensed for the sale of drugs within the area