Vous êtes sur la page 1sur 12

ADMINISTRATIVE BODIES

A) Advisory
(i) Drugs Technical Advisory Board
(ii) Drugs Consultative Committee
B) Analytical
(i) The Central Drugs Laboratory
(ii) Drugs Control Laboratories in States
(iii) Government Analyst
C) Executive
(i) Licensing Authorities (Central and State)
(ii) Drug Inspectors
(iii) Customs Collectors

DRUGS TECHNICAL ADVISORY BOARD


Constitution: Constituted by Central Govt. to advise state and Central Govts on
technical matters arising out of administration of the act.
18 members:
8-Ex-officio members
 Director General of Health Services (Chairman of the Board)
 Drugs Controller of India
 Director, Central Drugs Laboratory (CDL), Calcutta
 Director, Central Research Institute (CRI), Kasauli
 Director, Indian Veterinary Research Institute (IVRI), Izatnagar
 President, Pharmacy Council of India (PCI)
 President, Medical Council of India (MCI)
 Director, Central Drug Research Institute (CDRI), Lucknow
5 nominated members:
 Two persons nominated by Central Govt. from amongst persons who are
in charge of drug control in states
 One person from the pharmaceutical Industry nominated by Central Govt.
 Two Govt. Analysts, nominated by Central Govt.
5 Elected members:
 A teacher in Pharmacy or Pharmaceutical Chemistry Or Pharmacognosy
on the staff of an Indian. Univ. or an affiliated college elected by the
Executive Committee of the PCI.
 A teacher in medicine or therapeutics on the staff of an Indian. Univ. or
an affiliated college elected by the Executive Committee of the Medical
Council of India.
 One pharmacologist elected by the Governing body of the Indian Council
of Medical Research.
 One person elected by the Central Council of Indian Medical Association
 One person to be elected by the Council of the Indian Pharmaceutical
Association
 Term of office : Nominated and elected members hold office for 3 yrs,
Board may appoint committees, sub-committees and may appoint persons
who are not members of the board for these committees.

DRUGS CONSULTATIVE COMMITTEE


• Constituted by Central Govt. to secure uniformity in the Act throughout
India.
• It is advisory to Central Govt., State Govt., and DTAB
• Two representatives of Central Govt. nominated by Central Govt. and one
representative of each State Govt. nominated by the concerned Govt.

CENTRAL DRUGS LABORATORY


• The Central Govt. establishes a Central Drugs Laboratory (CDL),
Calcutta under the control of Director
• Functions:
1. To analyse or test samples of drugs or cosmetics sent to it by the customs
collectors or any authorized officers or courts; and
2. To carry out such other duties as entrusted to it by the Central Govt. or by
the State Govt. with permission of the Central Govt. after consultation
with DTAB

ALTERNATIVE AUTHORIZED LABORATORIES


Functioning of CDL
Despatch of samples for test or analysis:
• Samples for test or analysis shall be sent by registered post in a sealed
packet, enclosed together with a memorandum in Form 1, in an outer
cover addressed to the Director
• Packet as well as outer cover shall be marked with a distinguishing
number
• Copy of memorandum in Form 1 and a specimen impression of the seal
used to seal the packet shall be sent separately by registered post to the
Director
Recording of condition of seals:
On receipt of the packet, it shall be opened by an officer authorized in writing in
that behalf by the Director, who shall record the condition of the seal on the
packet
Report of result of test or analysis:
After test or analysis, the result of the test or analysis together with full
protocols of the test applied shall be supplied forthwith to the sender in Form 2
Fees: As specified in Schedule B
Signature of certificates: Certificates shall be signed by the Director or by an
officer authorized by the Central Govt. in the official Gazette
GOVERNMENT ANALYST
• Appointed by state govt. by notification in the official gazette for analysis
and testing of samples of drugs and cosmetics in the Drug Control
Laboratories
• Appointed by Central Govt. for specified categories of drugs or cosmetics
• Person appointed should have no financial interest in the import/ mfg./
sale of drugs/cosmetics
Qualifications:
1. Graduate in Medicine / Science / Pharmacy / Pharm. Chem. of a
University established in India or has an equivalent qualification
recognized and notified by Central Govt.
+ not less than 5 yrs experience in the testing of drugs in a lab under the
control of :
A govt. analyst appointed under the Act
Head of an institution or testing lab approved for the purpose by
appointing authority or
+ not less than 2 yrs training in the testing of drugs including items stated in
Schedule C at Central Drugs Laboratory
2. A post graduate degree in medicine or science or pharmacy or
pharmaceutical chemistry of a recognised university or has an equivalent
qualification recognized and notified by the Central Govt.
or Associateship Diploma of the Institution of Chemists (India) obtained with
‘Analysis of Drugs and Pharmaceuticals’ as a subject
+ not less than 3 yrs experience in testing of drugs in a lab under the control of
A govt. analyst appointed under the Act
Head of an institution or testing lab approved for the purpose by
appointing authority or
+ not less than 2 yrs training in the testing of drugs including items stated in
Schedule C at Central Drugs Laboratory
For examination of items of Schedule C:
• Persons appointed as above having degree in Medicine, Physiology,
Pharmacology, Microbiology, Pharmacy + not less than six months training /
experience in an Institution / lab approved by the appointing authority
• Persons appointed as above but not having suitable degree should have
experience or training in testing of Schedule C drugs for a period of not less
than 3 yrs in an Institution / lab approved by the appointing authority or have
completed 2 yrs training in testing of drugs including items stated in
Schedule C in the Central Drugs Laboratory
• For a period of four years from the date on which Chapter IV of the Act
takes effect in the States, persons whose training and experience are regarded
by the appointing authority as affording, subject to such further training, if
any, as may be considered necessary, a reasonable guarantee of adequate
knowledge and competence, may be appointed as Government Analysts. The
persons so appointed may, if the appointing authority so desires, continue in
service after the expiry of the said period of four years;
• Provided further that for the purpose of examination of Anti-sera,
Toxoid and Vaccines and Diagnostic Antigens for Veterinary use:
• The person appointed shall be a person who is a graduate in Veterinary
Science, or general science, or medicine or pharmacy and has had not
less than five years’ experience in the standardization of biological
products or person holding a post-graduate degree in Veterinary Science,
or general science, or medicine or pharmacy or pharmaceutical
chemistry with an experience of not less than three years in the
standardization of biological products
Duties of Government Analyst:
• To cause analysis or testing of samples of drugs / cosmetics sent to him
by Drug Inspectors or other persons under the provisions of the Act for
mfg/sale/distribution and furnish reports as per rules.
• To forward from time to time reports giving the results of analytical work
and research with a view to their publication at the discretion of the Govt.
• Procedure to be followed
on receipt of sample

LICENSING AUTHORITY
• State Govt.: Each State Govt. employs Licensing Authority to issue
licence for manufacture, sale, distribution of drugs / cosmetics within the
state. They can Issue / refuse license/Cancel or suspend license
• Central Govt. appoints licensing authority to issue licence for import of
drugs
• DRUGS CONTROLLER OF INDIA IS CENTRAL LICENSE
APPROVING AUTHORITY
Qualifications:
1. He is a graduate in Pharmacy / Pharmaceutical chemistry / Medicine with
specialization in Clinical pharmacology or Microbiology from a
University established in India
2. He has experience in manufacturing or testing of drugs or enforcement of
the provisions of the Act for a minimum period of 5 yrs.
The requirement of academic qualification is not applicable to inspectors and
Government Analysts appointed before 12th Apr 1989.
CONTROLLING AUTHORITY
• All inspectors at central and state level are under their control.
• Qualifications :
1. He is a graduate in Pharmacy / Pharmaceutical chemistry / Medicine with
specialization in Clinical pharmacology or Microbiology from a
University established in India
2. He has experience in mfg or testing of drugs or enforcement of the
provisions of the Act for a minimum period of 5 yrs.
(The requirement of academic qualification is not applicable to inspectors
and Government Analysts appointed before 12th Apr 1989).
DRUG INSPECTORS
• Appointed by the Central Govt. or State Govt. for the specified area by
notification in the official gazette
• Having prescribed qualifications
• Should have no financial interest in the import, manufacture or sale of the
drugs or cosmetics
• QUALIFICATIONS FOR DRUG INSPECTORS
A graduate in pharmacy or pharmaceutical sciences or medicine with
specialization in Clinical Pharmacology or Microbiology of a recognized
university;
Provided that for the purpose of Inspection of Manufacture of substances
specified in Schedule C, a person appointed as a Drug Inspector should have,
(i) Not less than 18 months experience in the manufacture of atleast one of
the substances specified in Schedule C; or
(ii) Not less than 18 months experience in testing of atleast one of the
substances specified in Schedule C in a approved laboratory; or
(iii) Not less than 3 years experience in the inspection of firms
manufacturing any of the substances specified in Schedule C during the
course of their services as the Drug Inspectors
POWERS OF DRUG INSPECTORS
Within the local limits for which the inspector is appointed, he may
i) Inspect:
a) Any premises wherein any drug or cosmetic is being manufactured. And
also he may inspect the means employed for standardizing and testing the
drug or cosmetic
b) Any premises wherein any drug or cosmetic is being sold or stocked or
exhibited or offered for sale or distributed
ii) Take samples of any drug or cosmetic:
a) which is being manufactured or being sold or is stocked or offered for
sale or exhibited or being distributed
b) from any person conveying, delivering or preparing to deliver any drug or
cosmetic to a purchaser or a consignee
c) iii) Search any person in connection with the offence under this
chapter at all reasonable times
d) (iv) Enter and search at all reasonable times, any place or premises in
which he has reason to believe that an offence is being committed or has
been committed
e) (v) Stop and search any vehicle or conveyance which he has reason to
believe, used for carrying any drug or cosmetic in respect of which
offence has been or is being committed
f) (vi) Give order in writing to the person in possession of drug or
cosmetic in respect of which offence has been committed not to dispose
stock of such drug or cosmetic for a specified period not exceeding
twenty days or unless the defect may be removed by the possessor of the
drug or cosmetic, and may seize the stock of such drug or cosmetic or any
substance /article employed for commission of offence
g) (vii) Examine any record, register, document, or any other material
object found while exercising above powers and seize the same if he has
reason to believe that it is an evidence of commission of an offence under
the Act
h) (viii) Exercise any other powers as may be necessary, for carrying out
the purpose of this Act and the rules made thereunder
DUTIES OF DRUG INSPECTORS
In relation to sale of drugs and cosmetics:
Subject to instructions of the Controlling Authority
(a) To inspect atleast once a year all establishments licensed for sale of drugs in
the area assigned to him and to satisfy himself whether the conditions of the
licences are observed or not
(b) If he thinks necessary to obtain and send samples of imported drugs and
cosmetics for test or analysis, which are being sold or stocked in contravention
of the provisions of this Act
(c) To investigate any complaint made in writing to him
(d) To institute prosecutions in case of the breach of the Act and Rules
(e) To maintain the records relating to all inspections and actions taken by him
and to submit copies of such records to the controlling authority
(f) To make inquiries and inspections regarding the sale of drugs in
contravention of the Act
(g) To detain the imported packages, if he suspects to contain drugs the import
of which is prohibited
In relation to manufacture of drugs and cosmetics:
Subject to instructions of the Controlling Authority
(a)To inspect atleast once a year all premises licensed for manufacture of drugs
in the area assigned to him and to satisfy himself whether the conditions of the
licences and provisions of the Act and Rules are observed or not
(b) To inspect premises licensed for mfg of drugs specified in Schedule C and
C(1) and to observe process of manufacture, means employed for
standardization and testing of drugs, storage conditions, qualifications of
technical staff employed and all other details of construction, location,
administration of establishment etc. which are likely to affect potency or purity
of product.
(c) To send after each inspection, a detailed report of inspection to controlling
authority with details of conditions of licence and provisions of the Act and
Rules being observed and those not observed.
(d) To take samples of drugs manufactured on premises and send them for test
or analysis
(e) To check all records and registers required to be maintained under rules.
(f) To institute prosecutions for breaches of Act
PROCEDURE OF INSPECTORS
For taking samples of drug and dispatching them to laboratory :
1. Where an Inspector takes any sample of a drug or cosmetic, he shall tender
the fair price thereof and may require a written acknowledgment therefor.
2. Where the price is refused, he shall tender a receipt therefor in the
prescribed form.
3. Where an Inspector takes a sample of a drug or cosmetic for the purpose
of test or analysis, he shall intimate such purpose in writing in the prescribed
form to the person from whom he takes it and, in the presence of such person
unless he wilfully absents himself, shall divide the sample into four portions and
effectively seal and suitably mark the same and permit such person to add his
own seal and mark to all or any of the portions so sealed and marked.
4. Where the sample is taken from premises whereon the drug or cosmetic is
being manufactured, it shall be necessary to divide the sample into three
portions only
5. Where the drug or cosmetic is made up in containers of small volume, instead
of dividing a sample as aforesaid, the Inspector may, and if the drug or cosmetic
be such that it is likely to deteriorate or be otherwise damaged by exposure
shall, take three or four, as the case may be, of the said containers after suitably
marking the same and, where necessary, sealing them.
6. The Inspector shall restore one portion of a sample so divided or one
container, as the case may be, to the person from whom he takes it, and shall
retain the remainder and dispose of the same as follows:—
(i) one portion or container he shall forthwith send to the Government Analyst
for test or analysis;
(ii) the second he shall produce to the Court before which proceedings, if any,
are instituted in respect of the drug or cosmetic;
(iii) the third, where taken, he shall send to the person, if any, whose name,
address and other particulars have been disclosed as manufacturer or his agent
For seizure of stocks:
• Whenever inspector suspects contravention he may seize any stock of
such drug or records, registers, documents which are believed to be
evidence of commission of offence, he should at the earliest inform a
judicial magistrate and take his order for custody.
• Or He may order not to dispose off stock in prescribed format (form 15)
• If he takes above action he should
• Use all means to ascertain if there is contravention, if not return stock
• If defect can be remedied, allow to do so and after satisfaction, revoke
order
CUSTOMS COLLECTORS
• The customs collectors or person on his behalf may detain imported
package which he suspects to contain drug / cosmetic import of which is
prohibited, report detention to Drugs Controller and if required forward
sample to CDL
• Laws relating to Sea Customs Act are applicable.