Administration of the act and rules – Drugs and Cosmetic Act

Administration of the act and rules

A) Advisory :

                1)Drugs
Technical Advisory Board-DTAB

                2)Drugs
Consultative Committee-D.C.C.

B) Analytical :

                1)Central
Drugs Laboratory – CDL

                2)Drug Control Laboratory in states

                3)Government  Analysts

C) Executives:

                1)
Licensing authorities

                2)
Controlling authorities

                3) Drug
Inspectors

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

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;

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

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

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

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

       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

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

Functions:

       Testing  of drug sample

       Analysis
of food sample

       Analysis
of excise sample

Government analyst

These
officers are appointed by the central or state government and perform the
duties

       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

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.

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.

       (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

Drugs Inspector

Qualification

1       Persons having qualification for
appointment as government, as Governmental Analysis for allopathic drugs; or

2        
having
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
this purpose.

 

Power:

a) Inspect, —

(i) Any premises where in any drug or cosmetic is being
manufactured.

(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
consignee.

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.

Qualifications

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;
or

q  enter
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
committed; or

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,
committed

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
committed

q  exercise
such other powers as may be necessary for carrying out the purposes of the Acts
or Rules.

Duties of Inspectors

A) Inspection of premises licensed for sale:

§  Inspect
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
observed.

§  Procure
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.

§  To
investigate any complaints made to him in writing & to institute
prosecutions in respect to the breaches of the act.

§  To
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

§  To
make enquiries and inspections as may be necessary to detect sale of drugs in
contravention to the Act.

§  When
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

Ø  Inspect
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.

Ø  In
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.

Ø  To
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.

Ø  To
take samples of drugs manufactured on premises & send them for test or analysis.

Ø  To
institute prosecutions in respect of breaches of Act and Rules.

Procedure for Drug Inspectors

Ø  An
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)

Ø  He
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.

Ø  The
sample if made into small volume is likely to deteriorate, Inspector can take
three or more containers when necessary after suitably marking it.

Ø  One
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.

Ø  Inspector
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.

Ø  If
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.

Ø  If
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
requisite license.

Ø  Any
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.

Ø  When
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.

Ø  Every
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.

Ø  Willfully
obstructing the Inspector or refusing to provide any record or register is
punishable with imprisonment up to three years, or with fine or both.

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