PHARMACEUTICA
L JURISPRUDENCE
By: Priyanka Jain
Assistant Professor
Administration of The Act And Rules
1. The Drugs Technical Advisory Board (DTAB)
2. The Central Drugs Laboratory (CDL)
3. The Drugs Consultative Committee (DCC)
4. Government Drug Analysts
5. Licensing Authorities
6. Controlling Authorities
7. Drug Inspectors
1. The Drugs Technical Advisory Board (DTAB)
The Central Government constituted this board, so as to advise the Central
Government and the State Governments on technical matters arising out 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:
1. Ex-Officio memebers
2. Nominated members
3. Elected members
1. Ex-Officio memebers:
The Director General of Health Services, who shall be Chairman.
The Drugs Controller, India.
The Director of the Central Drugs Laboratory, Calcutta.
The Director of the Central Research Institute, Kasauli.
The Director of the Indian Veterinary Research Institute, Izatnagar.
The President of the Medical Council of India.
The President of the Pharmacy Council of India.
The Director of the Central Drug Research Institute, Lucknow.
[Link] members:
Two persons to be nominated by the Central Government from
among persons who are in charge of drugs control in the States.
One person nominated by the Central Government from the
Pharmaceutical Industry.
Two persons holding the appointment of Government analyst,
nominated by the Central Government.
[Link] members:
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 an Indian university or a college
affiliated there to.
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.
One pharmacologist to be elected by the Governing Body of the Indian
Council of Medical Research.
One person to be elected by the Central Council of the Indian Medical
Association.
One person to be elected by the Council of the Indian
Pharmaceutical Association.
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 persons to be secretary of
the board and other staffs, if necessary.
Provided that, the person nominated or elected, shall hold office
for so long as he holds the appointment of the office by virtue of
which he was nominated or elected to the Board.
The Board may constitute sub-committees and may appoint to
such sub-committees for such periods, not exceeding three
years.
2. The Central Drugs Laboratory (CDL)
The Central Government established a Central Drugs Laboratory
under the control of a Director to be appointed by the Central
Government, to carry out the functions entrusted to it by this Act
or any rules.
This was established in Calcutta to carry out the following
functions:
1. To analyse or test, samples of drugs as may be sent to it by the Custom
Collectors or Courts.
2. Since, CDL is not equipped for testing of all types of products, some
other Government labs and Institutes shall also perform the functions of CDL :
Central Research Institute, Kasauli; carries out the assigned functions in respect
of: Sera, vaccines, toxins, antigens, sterilized surgical sutures and ligatures,
Bacteriophage.
Pasteur Institute of India, Conoor and Enterovirus Research Centre, Mumbai
in respect of Polio vaccine.
Indian Veterinary Research Institute, Izatnagar or Mukteshwar in respect
of: antisera, toxoids, vaccines, diagnostic agents for veterinary use.
[Link] Drugs Consultative Committee (DCC)
This is also an advisory body constituted by the Central government for the
purpose of advising the Central government the State government and the
DTAB, on any matter tending to secure uniformity throughout India in the
administration of this Act.
1. The Drugs Consultative Committee shall consist of :
• Two representatives nominated by the central government and
• One representative nominated by each state government.
2. The Drugs Consultative Committee shall meet when required to do so by the
Central Government and shall have power to regulate its own procedure.
4. Government Drug Analysts
1. The Central and State Government both, by notification in the
Official Gazette, appoint such persons, having the prescribed
qualifications, to be Government Analysts for such areas in the State
and in respect of such drugs or classes of drugs or such cosmetics or
classes of cosmetics as may be specified in the notification.
2. A person to be appointed as Government analyst should not have
any financial interest in the import, manufacture or sale of drugs or
cosmetics.
Qualifications of Government Analyst
A graduate in medicine or science or pharmacy or pharmaceutical chemistry of a
recognized university, with not less than 5 years post graduate experience in the
testing of drugs;
OR
A post graduate degree in medicine or science or pharmacy or pharmaceutical
chemistry of a recognized university, with not less than 3 years experience;
OR
Diploma at the institution of chemists with ‘Analysis of Drugs and Pharmaceuticals’
as one of the subjects with not less than 3 years experience in the testing of drugs in
the laboratory under the control of: A government analyst; or Head of the
institution or testing laboratories approved by the government authorities.
Duties of Government Analysts
1. On receipt of a package of a sample from Drug Inspector, the analyst compares the
seals on packages with the specimen impression of the seal received separately and
notes the condition of seals.
2. Thereafter, analyse or test the samples of drugs and cosmetics sent to him by Drug
Inspectors or other persons and to furnish the reports.
3. On completion of analysis, he furnishes the reports of analytical and research work
to the Inspector in Form 13, along with test protocols applied.
Note: If purchaser want to analyse the drug or cosmetic, he has to make an application
for analysis in Form 14-A, with a prescribed fee. The reports of such drugs will be
furnished in Form 14-B, by Government analyst.
5. Licensing Authorities
1. These are appointed by the Central and State governments for the grant and the
renewal of a licenses for the import, manufacture, sale, distribution etc. of any drug
or cosmetic.
2. The licenses once issued, shall remain valid forever, unless suspended or cancelled by
the licensing authority.
3. The licensing authorities are mostly designated as Drug Controller.
4. The Drug Controller, India has recently been notified as the Central License
Approving Authority .
•Qualification of a Licensing Authority:
1. He must be a graduate in Pharmacy or Pharmaceutical chemistry or medicine
with specialization in Clinical Pharmacology or Microbiology, from a recognized
university.
2. He must be experienced in manufacture or testing of drugs for a minimum period
of 5 years.
6. Controlling Authorities
All Drug Inspectors appointed by the Central Government or the State
Government act are under the control of an officer appointed by respective
governments referred to as Controlling authority.
Qualification of a Controlling Authority:
He must be a graduate in Pharmacy or Pharmaceutical chemistry or
medicine with specialization in Clinical Pharmacology or Microbiology, from
a recognized university.
He must be experienced in manufacture or testing of drugs for a minimum
period of 5 years.
7. Drug Inspector
The Central Government or a State Government appoints such persons, having the
prescribed qualifications, to be Inspectors.
Who have not less than 18 months experience in the manufacture of at least one of the
substances specified in Schedule C; or
Who have not less than 18 months experience in testing of at least one of the
substances specified in Schedule C in a laboratory approved for this purpose by the
licensing authority; or
Who have gained experience of not less than 3 years in the inspection of firms
manufacturing any of the substances specified in Schedule C during the tenure of
their services as Drug Inspectors.
Duties of Drug Inspector:
1. To inspect:
Any premises wherein any drug or cosmetic is being manufactured and the means
employed for standardizing and testing the drug or cosmetic.
Any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or
offered for sale or distributed.
2. 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;
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;
3. For entering and searching any place, person or vehicle etc. in which he has reason
to believe that an offence has been, or is being, committed; or 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 an offence been or being committed;
