Useful for B.Pharm students

1. REGULATORY ISSUES IN INDIA FOR
ASU (Ayurveda, Siddha and Unani )
DRUGS
Dr.U.Srinivasa, M. Pharm., M.Phil., Ph.D.
Professor and Head, (Dept. of
Pharmacognosy)
Srinivas college of pharmacy, Mangalore.
Email. usreenivas1966@rediffmail.com

2. INTRODUCTION
Drugs play an important role in the health of both people
and the economy of a country.
Pharmaceutical drugs are available from a large number
of sources.
People and Governments willing to spend money on
drugs for many reasons so, it must be safe, effective and
good quality and used appropriately.

3. INTRODUCTION
This means, in turn, that development, production,
importation, exportation and subsequent distribution of
drugs must be regulated to ensure that they meet
prescribed standards.
Therefore, effective drug regulation is required to ensure
the safety, efficacy and quality of drugs as well as
accuracy and appropriateness of the drug information
available to the public.

4. Regulatory requirements
In an ideal world, the need for analysis should be
driven by the desire to assure the quality of a drug
product. However, in the real world the need for
pharmaceutical drug analysis is driven largely by
regulatory requirements.
A team consisting of R&D, QC, and QA unit members
develops these quality and compliance systems.

5. Regulatory requirements
• It should be one of the highest priorities of top
management and QA units to develop and monitor
these systems to comply with the cGMP and GLP
expectations.
• Compliance documents are needed, in addition to the
regulatory and research documents, to demonstrate the
integrity of the data.
• Compliance documents refer to those reports required
by GMP and/or utilized during the course of inspection
by a health authority

6. Functions of regulatory agencies
• Product registration (drug evaluation and authorization,
and monitoring of drug efficacy and safety);
• Regulation of drug manufacturing, importation, and
distribution; Regulation & Control of drug promotion and
information.
• Adverse drug reaction (ADR) monitoring.
• Licensing of premises, persons and practices.

7. Goal of drug regulation
• Main goal of drug regulation is to guarantee the safety,
efficacy and quality of drugs available to public

8. Regulations in India
Herbal drugs are regulated under the Drug and Cosmetic
Act (D&C) 1940 and Rules 1945 in India, where regulatory
provisions for Ayurveda, Unani, Siddha medicine are clearly
laid down.
Department of AYUSH is the regulatory authority and
mandate that any manufacture or marketing of herbal drugs
have to be done after obtaining manufacturing license, as
applicable.
.

9. Regulations in India
The D & C Act extends the control over licensing,
formulation composition, manufacture, labelling,
packing, quality and export.
Schedule “T” of the act lays down the good
manufacturing practice (GMP) requirements to be
followed for the manufacturing of herbal medicines

10. Regulations in India
The official Pharmacopoeias and formularies are available
for the quality standards of the medicines. First schedule
of the D & C Act has listed authorized texts, which have to
be followed for licensing any herbal product under the two
categories: ASU drugs & Patent or proprietary medicines.
In India, traditional medicines are governed by the Drugs
and Cosmetics Act of 1940 and the Drugs and Cosmetics
Rules of 1945.

11. Regulations in India
They regulate the import, manufacture, distribution and sale
of drugs and cosmetics
In 1959, the Government of India recognized the traditional
Indian system of medicine and amended the Drugs and
Cosmetics Act to include drugs which are derived from
traditional Indian Medicine.
No products derived from traditional systems may be
manufactured without a licence from the State Drug Control
Authorities

12. Regulations in India
• Patent and proprietary medicines derived from the
traditional systems must contain ingredients which are
mentioned in the recognized books of the above
systems, as specified in the Drugs and Cosmetics Act.
• The government in advised by a special committee and
an advisory board for Ayurvedic, Siddha and Unani
drugs.
• Pharmacopoeia committees have been constituted to
prepare Pharmacopeias' for all these systems.

13. DRUG TECHNICAL ADVISORY BOARD
(ASU DTAB)
The Central Government constitute a Board (to be called
the Drugs Technical Advisory Board) to advise the
Central Government and the State Governments on
technical matters arising out of the administration of D&C,
Act 1940.
The Board shall consist of the following members,

14. DRUG TECHNICAL ADVISORY BOARD
MEMBERS
• Director General of health
• Drug Controller, India
• Principle officer of ISM Director of the Central drugs
Laboratory
• Government Analyst
• Pharmacognocist
• Phyto-chemist
• 4 Person from ASU pharmacopeia committee
• 1 Teacher in Dravaguna
• 1 Teacher in Ilmul-advia
• 1 Teacher in Gunapadam
• 3 Person from ASU drugs industry
• 3 Practitioner of ASU medicine

15. Activities and responsibilities
It advices matter related to Drugs.
The nominated and elected members of the Board
shall hold office for three years, but shall be eligible for
re-nomination and re-election.
The Board may, subject to the previous approval of
the Central Government, regulating its own procedure

16. DRUG CONSULTATIVE COMMITTEE
(ASU DCC)
The Board shall consist of the following members,
It is also an Advisory Body consist of two
representative central government to be nominated by
Government .
One representative of each state Government to be
nominated by the State Government.

17. Functions
DCC to advise the Central Government, the State
Governments and the ASU-DTAB on any matter for the
purpose of securing uniformity throughout India in the
administration of this Act in so far as it relates to ASU
drugs.
 It shall meet when required.
 It has power to regulate its own procedure