For B.Pharm, 6th Sem

1. Regulatory Issues
in India
(ASU DTAB, ASU DCC)

2. What are regulations?
Legal norms for-
• What is required to be done for an intended
purpose?
• How and in what manner it can be done?
• What can not be done for achieving the
intended purpose?
• Penalizing the persons for committing any
omission from prescribed standards or for
commission of prohibited actions.
• Who can make, amend and enforce the
provisions?

3. Needs for Drugs Regulation
• To prescribe and enforce standards for
manufacturing, distribution, sale, marketing
and information of drugs.
• To ensure availability of quality drugs to the
people.
• To promote public protection from
hazards/harmful effects of drugs.

4. CONDITIONS FOR COMMERCIAL MANUFACTURING OF ASU
DRUGS
1. License of the manufacturing unit and
intended formulations
2. GMP Compliance
3. Adequate infrastructural facility, staff,
equipment, reference books, record keeping
etc.
4. Compliance to Standards given in the
pharmacopoeia.

5. Herbal drug regulations in India
• Provisions relating to the manufacture and
control of Ayurvedic, Siddha and Unani (ASU)
drugs have been prescribed in the Drugs and
Cosmetics act.
• This act describes the formation of Drugs
Technical Advisory Board (DTAB), which
consists of various nominated members and
the Drugs Consultative Committees (DCC).

7. The Ayurvedic, Siddha and Unani Drugs Technical AdvisoryBoard(ASU-
DTAB)
• The central government shall constitute a
board by notifying in the official gazette.
• The board shall advice the central as well as
state governments on technical matters arising
out of the section 33-C & 33D of the Drugs
and Cosmetic act and carry other functions
assigned.

8. A. Constitution of the board
The board shall consist of the following members.
• 1.The director general of health services, ex-officio.
• 2.The drugs controller, ex officio.
• 3.The director of Central Drugs Laboratory, Calcutta, ex officio.
• 4.One government analyst nominated by the central board.
• 5.One Pharmacognocist nominated by the central government.
• 6.One phytochemist nominated by the central government.
• 7.Four persons nominated by central government, among which two from the members of
Ayurvedic pharmacopoeia committee and one each from Unani and Siddha pharmacopoeia
committee.
• 8. One teacher in Dravyaguna and Bhaishajya kalpana to be nominated by central
government.
• 9. One teacher from ilmul-Advia and Taklis-wa-Dawasazi to be nominated by central
government.
• 10. One teacher in Gunapadam to be nominated by central government.
• 11. Three persons, one each represent the Ayurvedic, Siddha and Unani drug industry
tobenominated by central government.
• 12. Three persons, one each from amongst the practitioners of Ayurvedic, Siddha and Unani,
Tibb systems of medicine to be nominated by central government.

9. B. Functioning of the board
• The central government shall appoint a
chairman from amongst its members.
• The nominated members of the board shall
hold office for three years but shall be eligible
for re-nomination.
• The board may make bye- laws to regulate its
functioning and conduct of all activities.
• The central government shall appoint a
secretary of the board and shall provide the
board with such clerical and other staff.

10. The Ayurvedic, Siddha and Unani Drugs Consultative Committee
(ASU-DCC)
• The central government may constitute an
advisory committee as mentioned in
thesection33-D of the Drugs and Cosmetics
act. This committee may advice thecentral and
state governments and the Ayurvedic, Siddha
and Unani drugs technical advisory board
(ASU-DTAB) on any matter for the purpose of
securing uniformity in the administration of
this act (section 33-D) throughout India.

11. Constitution and functioning of
ASU-DCC
• The ASU-DCC shall consist of two persons
nominated by central government and one
person from the state government who act as
representative of the respective governments.
• The ASU-DCC shall meet when required to do
so by the central government and shall regulate
its own activities as per their requirements.

12. Regulations for the manufacture of Ayurvedic, Siddha and Unani (ASU)
drugs
• The Section 33-EEB of the Drugs and
Cosmetics act describes the regulations
for the manufacture and sale of ASU
drugs.
• The act has set some standards related to
the hygienic conditions, factory premises,
prohibition of manufacture and sale of
certain drugs and penalties for
contravention of this act.

13. A. Requirementsof factory premises and hygienic Conditions
• As per the act, it is mandatory to maintain proper hygienic conditions in the
factory premises along with the following requirements.
• Factory or industry involved in the manufacture of ASU drugs should not be
situated adjacent to open sewage, drain, public lavatory or any other factory
which produces obnoxious odour, large quantities of waste, dust or smoke.
• The premises of manufacturing unit shall be clean, hygienic and free from
insects, rodents and other contamination.
• Note":-All the sections fall under the Schedule-Z of the Drugs & Cosmetics
Act.
• The walls and floor of manufacturing rooms should be smooth, easily
cleanable with water and should not accumulate dust or waste products.
• The water used in the manufacture shall be pure and drinking quality. It
should be free from pathogenic organisms.

14. Contii..
• Adequate facility should be provided to process the containers
and closures for washing, cleaning, drying, etc and it should be
separated from the manufacturing unit.
• Suitable arrangements shall be provided for disposing waste
water and other materials in a manner that it does not affect the
health of people in the surrounding area.
• Personnel working in the factory should be free from
contagious diseases. Appropriate dress should be provided to
the workers based on the nature of their work.
• Adequate facilities for personal cleanliness such as soap,
towel, and antiseptics should be provided.
• Facilities for drinking water and separate wash rooms should
be provided for men and women.

15. B. Prohibition of manufacture and sale of certain ASU drugs
• The act prescribes some criteria to prohibit the manufacture and sale of
certain ASU drugs which are not manufactured or sold in accordance of the
rules.
• The following categories of ASU drugs can be prohibited from
manufacture and sale.
• Any misbranded, adulterated or spurious ASU drugs.
• Any proprietary or patented medicine which does not display the list of all
ingredients on the label of the container. The selling, stocking and
distribution of any ASU drug which has been manufactured in
contravention of the provisions of this act.
• The manufacture, sale and distribution of any ASU drugs for which license
has not been issued by the prescribed authority.
• The above rules do not apply to vaidyas and hakims who prepared ASU
drugs for the use of their own patients.
• The above rules do not apply to ASU drugs which are manufactured in
small quantities for the purpose of examination, test or analysis.

16. C. Power of central government to prohibit the manufacture,
sale &distribution of ASU drugs in public interest
• The section 33-EED of the Drugs and Cosmetics
act prescribes certain powers of the central
government based on which the government can
prohibit the manufacture, sale and distribution of
ASU drugs which involve any risk to humans or
animals or such drug does not have therapeutic
value as claimed by the manufacturer orany
misbranded and spurious drugs.
• Hence in such circumstance, the government may
prohibit the manufacture, sale &distribution of
drugs in public interest.

17. D. Penalty for the manufacture, sale and
distribution of prohibited ASU drugs.
• As prescribed under the section 33-1 of the Drugs and
Cosmetics act, any person himself on his behalf is engaged
in the manufacture, sale and distribution of prohibited ASU
drugs, penalty has been fixed as per the following
guidelines.
• *Any ASU drug which is deemed to be adulterated or
manufactured without a valid license shall be punishable up
to one year imprisonment and with fine up to 2 thousand
rupees.
• *Any ASU drug which is deemed to be spurious shall be
punishable with Imprisonment upto 1 to 3 years and with
fine up to 5 thousand rupees.
• *Any ASU drug which contravenes any other provision of
the act shall be punishable with imprisonment up to 3
months and with fine up to 500 rupees.

18. E. Manufacture on more than one set of premises
• The ASU drugs are manufactured on more
than one set of premises, a separate application
shall be made and a separate license shall be
obtained for each premises.

19. Overall Regulatory Framework for
ASU & H Drugs

20. References
1. V.D.Rangari. Pharmacognosy & Phytochemistry.
2.Pharmacopoeal standards for Ayurvedic Formulation
(Council of Research in Indian Medicine & Homeopathy)
3. P Mukherjee, Quality Control of Herbal Drugs: An Approach
to Evaluation of Botanicals. Business Horizons Publishers,
New Delhi, India, 2002.
4. S.S Agarwal and N Paridhabi. Herbal Drug Technology.
*For any regulatory/enforcement query, clarification or
guidance, go to-
 dcc-ayush@nic.in
 dc.katoch@gov.in