The document discusses regulatory aspects of Ayurvedic research and drug development. It outlines that Ayurvedic drugs play an important role in public health and the economy, so they must be regulated to ensure safety, efficacy, and quality. Regulatory requirements drive the need for drug analysis to assure standards are met. Key functions of regulatory agencies include product registration and evaluation, manufacturing and distribution regulation, and adverse reaction monitoring. The main goal is to guarantee safe, effective, and quality drugs for public use. The drug regulatory system in India is governed by both central and state authorities under the Drugs and Cosmetics Act of 1940. The guidelines are intended to help promote better research, evaluation, and understanding of Ayurvedic

1. Regulatory aspects of Ayurvedic
Research

2. Introduction
• Ayurvedic drugs play an important role in the health of both people
and the economy of a country.
• These 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.
• 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

3. 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 Ayurvedic 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.
• 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.

4. Key function 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.

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

6. The drug regulation
• Drug Laws
• Drug Regulatory Agencies
• Drug Regulatory Boards
• Quality Control
• Drug Information Centres etc.

7. Drug regulatory system in India
• Drugs and Health is in concurrent list of Indian
Constitution It is governed by both Centre and
State Governments under the Drugs &
Cosmetics Act, 1940 Drug regulatory system in
India Drugs and Health is in concurrent list of
Indian Constitution It is governed by both
Centre and State Governments under the
Drugs & Cosmetics Act, 1940

8. MAIN BODIES
• Central Drug Standard Control Organization
(CDSCO)
• Ministry Of Health & Family Welfare (MHFW)
• Indian Council Of Medical Research (ICMR)
• Indian Pharmaceutical Association (IPA)
• Drug Technical Advisory Board (DTAB)
• Central Drug Testing Laboratory (CDTL)
• Indian Pharmacopoeia Commission (IPC)
• National Pharmaceutical Pricing Authority (NPPA

9. Regulatory aspects of Ayurvedic
Research
• The purpose of the guidelines is
• To develop methodologies for research and evaluation;
• To improve the quality and value of research
• To provide appropriate evaluation methods to facilitate
the development of regulation and registration in ASU
medicines and other TM in a phased manner
• To help promote a better understanding of ASU
medicines and other TM.
• These guidelines are intended to serve as a reference
source for research scientists, registered medical
practitioners, manufacturers, and health authorities.

10. Regulatory aspects for Ayurvedic Product
approvals (experimental and clinical studies)