Administration of the act and rules
A) Advisory :
Technical Advisory Board-DTAB
B) Analytical :
Drugs Laboratory – CDL
2)Drug Control Laboratory in states
Drugs Technical Advisory Board (DTAB)
Director General of Health Services (Chairman)
of the Central Drugs Laboratory, Calcutta
Director of the Central Research Institute, Kasauli
of Indian Veterinary Research Institute, Izatnagar
President of Medical Council of India
President of the Pharmacy Council of India
of Central Drug Research Institute, Lucknow
1) Two persons by the Central
2) One person by the Central Government
from the pharmaceutical industry
3) Two persons holding the appointment
of Government Analyst under this Act
person, to be elected by the Executive Committee of the Pharmacy Council of
person, to be elected by the Executive Committee of the Medical Council of
pharmacologist to be elected by the Governing Body of the Indian Council of
person to be elected by the Central Council of the Indian Medical Association;
person to be elected by the Council of the Indian Pharmaceutical Association;
• To advise the Central
Government and the State Governments on technical matters
• To carry out the other functions
assigned to it by this Act
Drugs Consultative Committee (DCC)
It is also an advisory body constituted by central
representatives of the Central Government
representative of each State Government
- 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
Central Drug Laboratory (CDL)
Established in Calcutta, under the control of a
director appointed by the Central Government.
or test of samples of drugs/cosmetics sent by the custom collectors or
Q.C. of the imported samples
storage and distribution of internal standards
of reference standards and their maintenance
of microbial cultures
other duties entrusted by Central Government
as an appellate authority in matter of disputes
The Central Drugs Laboratory
for the establishment of a Central Drugs Laboratory under the control of a
director appointed by Central Government
Laboratory established in Calcutta has been entrusted with the following
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
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
Research Institute, Izantnagar and
Mukteshwar carries out functions in respect of antisera, vaccines, toxoids
& diagnostic antigens, all for Vetenary Use
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:-
• Testing of drug sample
of food sample
of excise sample
officers are appointed by the central or state government and perform the
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
Government may also similarly appoint Government Analysts in respect of such
drugs or classes of drugs or cosmetics as specified
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
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.
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
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.
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.
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.
Analyst has to submit a report in form 1 and unless full protocols are
supplied, the report cannot be regarded as conclusive evidence.
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
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
to inspect all establishments licensed for the sale of drugs within the area
assigned to him;
to satisfy himself that the conditions of the licenses are being observed;
to procure and send for test or analysis, if necessary, imported packages.
to investigate any complaint.
to maintain a record of all inspections made and action taken by him in
the performance of his duties,
to make such enquiries and inspections as may be necessary to detect the sale
of drugs in contravention to the Act;
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
1 Persons having qualification for
appointment as government, as Governmental Analysis for allopathic drugs; or
a degree in ayurveda, siddha or unani system and not less than three years
of 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
a) Inspect, —
(i) Any premises where in any drug or cosmetic is being
(ii) Any premises where in any drug or cosmetic is being
sold, or stocked or exhibited or offered for sale, or distributed;
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
Appointed by Central and State Governments.
He should be a person with out any financial interest in the
import, manufacture or sale of drugs or cosmetics.
They are deemed as public servants and are officially
subordinate to the Controlling Authority.
For appointment as DI, person must have a degree in
Pharmacy/Pharmaceutical Chemistry/Medicine with specialization in Clinical
Pharmacology/Microbiology from a recognized University;
For inspection of manufactured substances in Schedule C, the
DI must have 1) at least 18 months experience in manufacture of at least one of
the substance specified in schedule C 2) at least 18 month experience in
testing one of the item in schedule C 3) gained experience of NLT 3 yrs in
inspection of firms manufacturing any of the substances of Schedule C during
their tenure as services as DI
Powers of DI
He can 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 ;
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;
At all reasonable times with necessary assistance
search any person, who, he has reason to believe, has
secreted about his person, any drug or cosmetic in respect of which an offence
relating to manufacture sale or distribution has been, or is being, committed;
and search any place in which he has reason to believe an offence relating to
manufacture, sale or distribution of drugs or cosmetics has been, or is being
q 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 which an offence has been, or is being, committed,
and order in writing the person in possession of the drug or cosmetic not to
dispose of any stock that of for a specified period not exceeding 20 days or,
unless the alleged offence is such that the defect may be removed by the
possessor of the drug or cosmetic, seize the stock of such drug or cosmetic and
any substance or article by means of which the offence has been ,or is being,
q examine any record, register, document or any
other material object with any person or in any place mentioned above and seize
the same if it is likely to furnish the evidence as an offence
q require any person to produce any record,
register, or other document relating to the manufacture for sale or for
distribution of any drug or cosmetic with respect to which an offence has been
such other powers as may be necessary for carrying out the purposes of the Acts
Duties of Inspectors
A) Inspection of premises licensed for sale:
NLT twice an year all establishments licensed for sale of drugs within the area
assigned to him and to satisfy himself that the conditions of license are being
and send for tests or analysis, if he has reason to think that the drugs are
sold in contravention of provisions of Acts or Rules.
investigate any complaints made to him in writing & to institute
prosecutions in respect to the breaches of the act.
maintain all records of inspections made & actions taken by him including
taking of samples and seizure of stocks & to submit copies of such records
to the Controlling Authority
make enquiries and inspections as may be necessary to detect sale of drugs in
contravention to the Act.
so authorized by State Governments to obtain imported packages which he has
reason to suspect to contain drugs whose import is prohibited.
B) Inspection of Manufacture of Drugs
NLT twice a year all premises licensed for the manufacture of drugs within
the area allotted to him and satisfy himself that the
condition of license and provisions of Acts and Rules are observed.
establishments licensed to manufacture products specified in Schedule C and C1
inspect the process of manufacture, means employed for standardizing and
testing of drugs, methods & place of storage, technical qualifications of
staff employed & all details of location, construction & administration
of establishment likely to affect the potency or purity of drug.
send controlling authority after each inspection a detailed report indicating
conditions of license & provisions of Acts & Rules which are being
observed & which are being not observed.
take samples of drugs manufactured on premises & send them for test or analysis.
institute prosecutions in respect of breaches of Act and Rules.
Procedure for Drug Inspectors
Inspector taking any samples must pay its fair price & may require written
acknowledgement for the same. If price tendered is refused or when Inspector
seizes any stock of any drug or cosmetic, he should issue the receipt for the
same in prescribed form. (Form 16)
should inform the concerned person, the purpose of taking the sample in form 17
& divide the sample to four parts In his presence. Each portion is then
sealed & suitably marked. The person from whom the sample is taken must
also be allowed to add his mark of seal on the packet. If sample taken from a
manufacturing premises, it should be divided to three portions only.
sample if made into small volume is likely to deteriorate, Inspector can take
three or more containers when necessary after suitably marking it.
portion of sample is to be restored to the person, second part send to
Government analyst and third one is preserved for production before the court,
if required & fourth is sent to warrantor if any.
should sent sample to Government Analyst by registered post or by hand in
sealed packet enclosed together with memorandum in Form 18 in an outer cover
addressed to Government analyst.
the confiscated drug is not of standard quality, it should be reported to court
accordingly & court may order destruction of drug under the supervision of
Inspector in presence of such authority that the court may prescribe.
confiscated drug is of standard quality, Inspector may report court accordingly
and court may order sale of drugs by public auction to any party holding a
record, register or any other document sized by the Inspector should be
returned to the persons from whom they where seized or who produce the same
within a period of 20 days of such seizure or produce.
an Inspector seizes any record, register or document, or any other material
object, he should as soon as inform the same to the judicial magistrate &
take his orders to the custody thereof.
person for time being in charge of any premises where any drug or cosmetic is
manufactured or is kept for sale or distribution, on being required by the
Inspector is legally bound to disclose to the inspector the place where drug or
cosmetic is being manufactured or kept.
obstructing the Inspector or refusing to provide any record or register is
punishable with imprisonment up to three years, or with fine or both.