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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
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.