Executive Summary:
The Ministry of Ayush addresses concerns regarding the safety, efficacy, quality control, research, data collection, and export regulations of AYUSH medicines. It details mechanisms for quality assurance, research initiatives, the status of the Ayush Grid, and efforts to align export standards with international norms. The response references the Drugs and Cosmetics Act, 1940, and various schemes and bodies involved in regulating and promoting AYUSH practices.
Key Points / Main Content:
Quality Control and Regulation:
* The Drugs Cosmetics Act, 1940, and Drugs Rules, 1945, provide the regulatory framework for Ayurvedic, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs, mandating adherence to Good Manufacturing Practices (GMP).
* Drug Inspectors regularly collect samples for quality testing, and action is taken if products are found to be Not of Standard Quality.
* The Pharmacopoeia Commission for Indian Medicine Homoeopathy (PCIMH) sets quality standards for ASUH drugs, compliance with which is mandatory.
* Drug Testing Laboratories are recognized for testing ASUH drugs, with 108 private labs and 34 State/UT labs currently testing quality.
* The Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) supports Ayush pharmacies and Drug Testing Laboratories in achieving higher standards.
* A Pharmacovigilance Program monitors patient safety, adverse effects, and misleading advertisements related to ASUH drugs.
Research and Evidence Generation:
* The AYURGYAN Scheme supports capacity building, research, and integrated health research in AYUSH.
* Central Councils for Research in Ayurvedic Sciences, Unani Medicine, Homoeopathy, Siddha, and Yoga & Naturopathy promote research in AYUSH systems.
* Core research activities include medicinal plant research, drug standardization, pharmacological research, clinical research, and literary research.
Ayush Grid:
* The Ayush Grid is a digital initiative aligned with the Ayushman Bharat Digital Health Mission (ABDM) to transform the Ayush sector through ICT.
* The Ayush Grid does not collect data on traditional medicine.
Export Regulations:
* Quality parameters in ASUH drug pharmacopoeias are aligned with WHO and other international standards.
* The Ministry of Ayush encourages certifications of Ayush products.
* A dedicated Ayush vertical exists within the Central Drugs Standard Control Organization (CDSCO) to strengthen regulatory measures.
* CDSCO issues WHO Certificate of Pharmaceutical Product (WHOCoPP) to Ayush drugs meeting specified standards.
* The Quality Council of India (QCI) offers Ayush Standard and Ayush Premium marks based on third-party evaluations.
* The Ayush Export Promotion Council (AYUSHEXCIL) promotes exports and issues Registration Cum Membership Certificates and Certificates of Origin (COO).
* Central Council for Research in Ayurvedic Sciences (CCRAS) has developed three guidelines for validation research of the Ayush approach and drugs.
* CCRAS has generated scientific evidence of clinical efficacy and safety of 182 classical Ayurveda formulations in 40 disease conditions through clinical trials.
* Central Council for Research in Homoeopathy (CCRH) undertakes research activities such as Clinical Research, Drug Proving, Drug Verification, Drug validation, Drug Standardization, Public Health Research, Fundamental Research and Epidemic research either in intramural mode or in collaboration with different Universities institutes of repute.
Impact Analysis:
Manufacturers of ASUH Drugs:
* Impact: Must adhere to GMP standards and quality specifications outlined in the Drugs and Cosmetics Act, 1940, and the pharmacopoeias. They must also participate in quality testing programs.
* Action Required: Implement GMP, ensure product compliance with pharmacopoeial standards, and cooperate with drug inspectors for sample collection and testing.
Drug Inspectors and Drug Testing Laboratories:
* Impact: Responsible for collecting and testing drug samples to ensure quality and safety. Drug Testing Laboratories must meet recognition standards.
* Action Required: Conduct regular inspections and quality tests, and ensure laboratories are appropriately licensed and recognized.
Pharmacopoeia Commission for Indian Medicine Homoeopathy (PCIMH):
* Impact: Sets quality standards for ASUH drugs and acts as the Central Drugs Laboratory.
* Action Required: Continue to develop and update pharmacopoeial standards and provide testing and analysis services.
Ministry of Ayush:
* Impact: Oversees the regulation, promotion, and research related to AYUSH systems.
* Action Required: Continue implementing schemes like AOGUSY and AYURGYAN, support research initiatives, and promote the Ayush Grid.
Exporters of Ayush Products:
* Impact: Must meet international quality standards and may seek certifications like WHO-CoPP and Ayush Standard/Premium marks.
* Action Required: Align products with international standards, obtain necessary certifications, and utilize services offered by AYUSHEXCIL.
Researchers and Research Institutions:
* Impact: Can receive funding and support for research in AYUSH systems through various schemes and councils.
* Action Required: Participate in research programs, collaborate with relevant institutions, and adhere to research guidelines.
Key Entities Referenced
Ministry of Ayush: The Indian government ministry responsible for the development and promotion of AYUSH systems of medicine.
Drugs and Cosmetics Act, 1940: Indian legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics, including provisions for AYUSH drugs.
Drugs Rules, 1945: Rules formulated under the Drugs and Cosmetics Act, 1940, providing detailed regulations for the manufacture, testing, and sale of drugs, including AYUSH formulations.
Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIMH): A subordinate office under the Ministry of Ayush responsible for laying down formulary specifications and pharmacopoeial standards for ASUH drugs.
Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY): A Central Sector Scheme implemented by the Ministry of Ayush to support Ayush Pharmacies and Drug Testing Laboratories.
Ayush Grid: A digital initiative aimed at transforming the AYUSH sector through information and communication technology.
Central Drugs Standard Control Organization (CDSCO): The national regulatory authority for pharmaceuticals and medical devices in India, with an AYUSH vertical to strengthen regulatory measures for AYUSH drugs.
Central Council for Research in Ayurvedic Sciences (CCRAS): An apex organization under the Ministry of Ayush for undertaking, coordinating, formulating, developing and promoting research in Ayurvedic system.
GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
UNSTARRED QUESTION NO. 3425
TO BE ANSWERED ON 08th AUGUST 2025
“Development and Regulation of AYUSH Medicines”
3425. Shri Anup Sanjay Dhotre:
Will the Minister of Ayush be pleased to state:
(a) whether any mechanisms are put in place to ensure safety, efficacy and quality control of
AYUSH formulations and if so, the details thereof;
(b) whether any National AYUSH Pharmacopoeia or Certification Body has been developed for
this purpose and if so, the details thereof;
(c) whether the Government is encouraging research and evidence generation for AYUSH-
based therapies;
(d) if so, the details thereof;
(e) the current status of the Ayush Grid for data collection on traditional medicines; and
(f) whether the Government is considering tighter regulatory standards for export-quality
AYUSH drugs and if so, the details thereof?
ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) and (b) The mechanisms to ensure safety, efficacy and quality control of Ayush
formulations and details of Pharmacopoeia Commission for Indian Medicine &
Homoeopathy (PCIM&H) are as follows: -
1. The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory
provisions for Ayurvedic, Siddha, Sowa-Rigpa, Unani, and Homoeopathy drugs. It is
mandatory for the manufacturers to adhere to the prescribed requirements in compliance
with the Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of Drugs
Rules, 1945 respectively including safety, effectiveness and quality standards of drugs
given in the respective pharmacopoeia.
12. Drug Inspectors collect medicine samples regularly from manufacturing firms or shops
within their jurisdiction and send them to Drug Testing Laboratory under Drug Control
department for quality testing and if any sample is found to be ‘Not of Standard Quality’,
appropriate action is initiated such as preventing the sale of the products from the market
and appropriate legal actions as per Drugs and Cosmetics Act, 1940 and Rules made
thereunder.
3. Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H),
subordinate office under Ministry of Ayush lays down the formulary specifications and
pharmacopoeial standards for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H)
drugs which serves as official compendia for ascertaining the quality (identity, purity and
strength) of the ASU&H drugs. As per the Drugs & Cosmetics Act, 1940 and rules
thereunder, the compliance to this quality standards are mandatory for the production of
ASU&H drugs being manufactured in India. So far, 2269 quality standards on raw
materials (single drugs of plant/ animal/ mineral/ metal/ chemical origin) used in ASU&H
drugs, 426 quality standards of ASU formulations and 2799 formulary specifications of
ASU drugs has been published. In addition to above, supporting documents in the form of
Macro-Microscopic & TLC Atlas on 392 single drugs incorporated in API are also
published. PCIM&H also acts as the Central Drugs Laboratory for Indian Medicine and
Homoeopathy for the purpose of testing or analysis of ASU&H Drugs.
4. Drug Testing Laboratories are being recognised under Rule 160 A to J of the Drugs Rules,
1945 for carrying out such tests of identity, purity, quality and strength of Ayurvedic,
Siddha, Sowa-Rigpa, Unani and Homoeopathy drugs. As on date, 108 private laboratories
are approved or licensed under the provisions of Drugs Rules, 1945 for manufacturers. 34
Drug Testing Laboratories of State/UTs are testing quality of Ayurvedic, Siddha, Sowa-
Rigpa, Unani and Homoeopathy drugs and raw materials for legal samples.
5. Ministry of Ayush has implemented Central Sector Scheme Ayush Oushadhi Gunvatta
Evam Uttpadan Samvardhan Yojana (AOGUSY) to support Ayush Pharmacies and Drug
Testing Laboratories to achieve higher standards under one of the components.
26. Pharmacovigilance Program for Ayurveda, Siddha, Unani, and Homoeopathy (ASU & H)
Drugs is one of the components under the AOGUSY Scheme of Ministry of Ayush. This
is established with an objective of improving patient healthcare and safety in relation to the
use of medicines, developing culture of documenting adverse effects, promoting education
and training in Pharmacovigilance, and surveillance of misleading advertisements
appearing in the print and electronic media.
(c ) and (d) Ministry of Ayush is running/implementing the Central Sector Scheme namely
AYURGYAN Scheme from FY 2021-22.The Scheme has 03 components viz. (i) Capacity
Building & Continuing Medical Education (CME) in Ayush (ii) Research & Innovation in Ayush
from the FY 2021-22 and iii) Ayurveda Biology Integrated Health Research is also added under
the scheme from this FY 2023-24.Under the Research & Innovation in Ayush and Ayurveda
Biology Integrated Health Research component, financial assistance is provided to the
Organizations/Institutions for research studies, for promotion of research in Ayush system.
Further, Government of India has established Central Council for Research in Ayurvedic Sciences,
Central Council for Research in Unani Medicine, Central Council for Research in Homoeopathy,
Central Council for Research in Siddha and Central Council for Research in Yoga & Naturopathy
under the Ministry of Ayush as apex organizations for undertaking, coordinating, formulating,
developing and promoting research in Ayush system on scientific lines. Core Research activities
comprise of Medicinal Plant Research (Medico-Ethno Botanical Survey, Pharmacognosy and
cultivation), Drug Standardization, Pharmacological Research, Clinical Research, Literary
Research & Documentation and Tribal Health Care Research Programme. Research activities are
carried out through its peripheral Institutes/Units located across the country and also in
collaboration with various Universities, Hospitals and Institutes. Activities carried out by Research
councils under Ministry of Ayush encouraging research and evidence generation for AYUSH-
based therapies are placed at Annexure I.
(e ) The Ayush Grid is a comprehensive digital initiative aimed at transforming the Ayush sector
through the power of information and communication technology (ICT). It is aligned with the
Ayushman Bharat Digital Health Mission (ABDM). Ayush Grid specifically doesn’t collect any
data on traditional medicine.
3(f ) The quality parameters included in the Pharmacopoeias and Formularies of Ayurveda, Siddha,
Unani & Homoeopathic (ASU&H) drugs prescribing mandatory regulatory standards have been
identified to align the parameters prescribed by WHO/other major pharmacopoeias prevalent
worldwide. These Pharmacopoeias and Formularies are also included in WHO-Index of World
Pharmacopoeias and Pharmacopoeial Authorities. Implementation of these pharmacopoeial
standards ensures that the medicines conform to optimum quality standards in terms of identity,
purity and strength.
Further Ministry of Ayush encourages following certifications of Ayush products as
per details below:-
• An Ayush vertical has been created in Central Drugs Standard Control Organization
(CDSCO) to strengthen regulatory measures ensuring safety and quality of Ayush drugs.
Further, CDSCO issues WHO Certificate of Pharmaceutical Product (WHO-CoPP) to
Ayush drugs having compliance to such standards.
• Quality Certifications Scheme implemented by the Quality Council of India (QCI)
for grant of Ayush standard and Ayush premium marks to Ayurvedic, Siddha and Unani
products on the basis of third-party evaluation of quality in accordance with the status of
compliance to domestic and international standards respectively.
Ayush Export Promotion Council (AYUSHEXCIL) is established by the Ministry of
Ayush, Government of India and supported by Ministry of Commerce to promote the export of
products and services related to Ayush systems. Directorate General of Foreign Trade has
authorized AYUSHEXCIL to issues Registration Cum Membership Certificate and has recently
been authorised to issue Certificate of Origin (COO). COO is a regulatory document for exports
in international trade, required by customs authorities in the importing country to verify the origin
of goods and determine applicable tariffs, taxes, and trade regulations. It also helps ensure
compliance with free trade agreements and other trade policies.
****
4Annexure I
Activities carried out by Research councils under Ministry of Ayush encouraging research and
evidence generation for AYUSH-based therapies are as follows: -
1. Central Council for Research in Ayurvedic Sciences (CCRAS) has developed three
guidelines for validation /research of the Ayush approach and drugs namely:
➢ General Guidelines for Drug Development of Ayurvedic Formulations.
➢ General Guidelines for Safety/Toxicity evaluation of Ayurvedic formulation.
➢ General Guidelines for Clinical Evaluation of Ayurvedic Interventions.
2. CCRAS has generated scientific evidence of clinical efficacy and safety of 182 classical
Ayurveda formulations in 40 disease conditions through clinical trials. The Council is also
conducting scientific validation of new combinations (coded drugs) through systematic process of
drug development viz. drug standardization and quality control, preclinical safety/toxicity studies
and biological activity studies (as appropriate) and clinical trials as per requirement. Further, the
Council is in active collaboration with institutes of national repute such as All India Institute of
Medical Sciences (AIIMS), Banaras Hindu University (BHU), Indian Institute of Technology (IIT)
Delhi, Indian Council of Medical Research (ICMR), Council of Scientific & Industrial Research
(CSIR), Jawaharlal Nehru University (JNU) etc. During the financial year 2024-25, 8 collaborative
research projects have been completed.
3. To encourage research and evidence generation for Unani Medicine based therapies; the
CCRUM involve Unani Medicine Experts and Modern scientists including Pharmacologists, Bio-
chemists, Botanists, Pathologists, Microbiologists and Chemists etc. for planning and finalization
of the Intramural and collaborative studies protocols. These studies are monitored by Scientific
Advisory Committee (SAC) and Research Sub-committee at Headquarters and Institutional Multi-
disciplinary Research Advisory Committee (IMRAC) & Institutional Ethics Committees (IEC) at
Peripheral Institutes. All of these committees involve Multidisciplinary experts so that evidence-
based Unani Medicine therapies and products may be developed. The Council is following all the
5Guidelines to ensure that Unani Medicine research is conducted with rigorous scientific
methodology, transparency, and accountability. The Research Drugs are being is manufactured by
the Councils GMP certified Pharmacy at Hyderabad and Chennai.
4. Central Council for Research in Homoeopathy undertakes research activities such as Clinical
Research, Drug Proving, Drug Verification, Drug validation, Drug Standardization, Public Health
Research, Fundamental Research and Epidemic research either in intramural mode or in
collaboration with different Universities/ institutes of repute. CCRH has 27 institutes/Units and 06
Homoeopathic treatment centers across the country which undertake research in the
aforementioned fields, which help in promoting and development of Homoeopathic system of
medicines. CCRH has signed 12 MoU and 01 Letter of Intent in the field of homoeopathic
medicine with medical centres/hospitals, Universities and Scientific institutes/organisations in
Germany, Canada, USA, UK, Argentina, Israel, Armenia, Mexico and Brazil. These Memorandum
of Understanding (MoU) are broadly aimed at strengthening & developing co-operation in the
field of Research & Education in Homoeopathic system of Medicine. This encompasses joint
research projects; exchange of information; organisation of seminars/workshops etc. Academic
chair in Homoeopathy has also been established through MoU with Yerevan State Medical
University, Government of Armenia to promote education and spread of Homoeopathy.
6