Executive Summary:
This document outlines the steps taken and proposed by the Indian government, specifically the Ministry of Ayush, to ensure the qualitative production and distribution of AYUSH medicines, and to promote broader research in AYUSH medicines. It details regulatory provisions, quality control measures, and research schemes implemented from FY 2021-22 to 2026. Key aspects include adherence to the Drugs and Cosmetics Act, the role of the Pharmacopoeia Commission, and the implementation of the AYURGYAN Scheme.
Key Points / Main Content:
Qualitative Production and Distribution of AYUSH Medicines:
* The Drugs and Cosmetics Act, 1940, and associated rules provide the regulatory framework for manufacturing Ayurvedic, Siddha, Sowa Rigpa, Unani, and Homoeopathy drugs.
* Rule 160 A to J of the Drugs Rules, 1945, outlines guidelines for approving Drug Testing Laboratories for testing identity, purity, quality, and strength of Ayurvedic, Siddha, and Unani drugs.
* The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIMH) sets Formulary specifications and Pharmacopoeial Standards for AYUSH drugs, serving as the official compendia for quality control. Compliance is mandatory.
* Pharmacovigilance Centres monitor and report adverse drug reactions to State Regulatory Authorities.
* The Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana (AOGUSY) is implemented from 2021-2026 to strengthen AYUSH Pharmacies and Drug Testing Laboratories.
* An Ayush vertical within the Central Drugs Standard Control Organization (CDSCO) strengthens regulatory measures, and CDSCO issues WHO Certificate of Pharmaceutical Product (WHOCoPP) for compliant drugs.
Broader and Deep Research in AYUSH Medicines:
* The AYURGYAN Scheme, implemented from FY 2021-22, includes Capacity Building (CME), Research Innovation, and Ayurveda Biology Integrated Health Research.
* Financial assistance is provided to eligible organizations for clinical, fundamental, pharmaceutical, literary, and medicinal plant research.
* Central Councils (CCRAS, CCRUM, CCRH, CCRS, CCRYN) under the Ministry of Ayush are apex organizations for research in AYUSH systems, covering medicinal plant research, drug standardization, pharmacological research, clinical research, and tribal healthcare.
Impact Analysis:
AYUSH Drug Manufacturers:
* Impact: Must comply with the Drugs and Cosmetics Act, 1940, and quality standards set by PCIMH, including mandatory testing and reporting of adverse reactions. Subject to regulatory oversight by CDSCO.
* Action Required: Adhere to quality control guidelines, ensure products meet Pharmacopoeial Standards, participate in Pharmacovigilance reporting, and prepare for potential inspections and certifications.
Drug Testing Laboratories:
* Impact: Laboratories must adhere to Rule 160 A to J of the Drugs Rules, 1945, to gain approval for testing AYUSH drugs. May receive funding to upgrade to higher standards.
* Action Required: Comply with regulatory guidelines for approval, conduct tests as required, and explore opportunities for upgrading facilities under the AOGUSY scheme.
Researchers and Research Institutions:
* Impact: Eligible organizations/institutions can receive financial assistance for research in AYUSH under the AYURGYAN Scheme.
* Action Required: Review scheme guidelines, submit proposals for funding, and conduct research in alignment with the priorities of the Ministry of Ayush and Central Councils.
State Regulatory Authorities:
* Impact: Responsible for enforcing drug regulations, receiving reports of adverse drug reactions, and collaborating with CDSCO and other agencies.
* Action Required: Enforce the Drugs and Cosmetics Act, monitor drug quality, respond to adverse event reports, and coordinate with national regulatory bodies.
Consumers of AYUSH Medicines:
* Impact: Benefit from improved quality control and safety of AYUSH medicines.
* Action Required: Report any adverse reactions to AYUSH medicines to healthcare providers or regulatory authorities.
Key Entities Referenced
Ministry of Ayush: The Indian government ministry responsible for the development and promotion of AYUSH systems of medicine.
Shri Biplab Kumar Deb: Member of Parliament who raised the question about AYUSH medicines in the Lok Sabha.
Shri Prataprao Jadhav: The Minister of State IC of the Ministry of Ayush who provided the answer to the question.
Drugs and Cosmetics Act, 1940: Indian legislation regulating the manufacture, sale, and distribution of drugs and cosmetics, including specific provisions for AYUSH medicines.
Drugs Rules, 1945: Rules under the Drugs and Cosmetics Act, 1940 providing regulatory guidelines for approval of Drug Testing Laboratories for testing Ayurvedic, Siddha and Unani drugs.
Pharmacopoeia Commission for Indian Medicine Homoeopathy PCIMH: An organization that lays down the Formulary specifications and Pharmacopoeial Standards for Ayurveda, Siddha, Unani and Homoeopathic drugs.
Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana AOGUSY: A Central Sector Scheme implemented for the year 2021-2026 aimed at strengthening and upgrading Ayush Pharmacies and Drug Testing Laboratories.
Central Drugs Standard Control Organization CDSCO: The national regulatory body for pharmaceuticals and medical devices in India, with an Ayush vertical to strengthen regulatory measures ensuring safety and quality of Ayush drugs.
GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
UNSTARRED QUESTION NO. 1086
TO BE ANSWERED ON 25TH JULY, 2025
“Production and Distribution of AYUSH Medicines”
1086. Shri Biplab Kumar Deb:
Will the Minister of Ayush be pleased to state:
(a) the steps taken by the Government for the qualitative production and distribution of
AYUSH medicines; and
(b) the steps proposed to be taken by the Government for broader and deep research in
AYUSH medicines?
ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) The Government has taken following steps for the qualitative production of Ayush
medicines:
1. The Drugs and Cosmetics Act, 1940 & rules made thereunder have exclusive regulatory
provisions regarding manufacture for sale or for distribution of Ayurvedic, Siddha, Sowa-
Rigpa, Unani, and Homoeopathy drugs.
2. Rule 160 A to J of the Drugs Rules, 1945 provides the regulatory guidelines for approval
of Drug Testing Laboratories for carrying out such tests of identity, purity, quality and
strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of
these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs.
3. Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) on behalf of
Ministry of Ayush lays down the Formulary specifications and Pharmacopoeial Standards for
Ayurveda, Siddha, Unani and Homoeopathic drugs, which serves as an official compendia
for ascertaining the Quality Control (identity, purity and strength) of Ayush drugs, as per the
Drugs & Cosmetics Act, 1940 & rules made thereunder. Compliance to these quality
standards are mandatory for Ayush drugs being manufactured in India.
4. Pharmacovigilance Centres for Ayurveda, Siddha, Unani and Homoeopathic drugs set up
in different parts of the country under the Central Sector Scheme of Ministry of Ayush are
mandated to report adverse drug reactions to the respective State Regulatory Authorities.
5. Central Sector Scheme, Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana
(AOGUSY) has been implemented for the year 2021-2026. One of the components of this
Scheme is to strengthen and up-grade Ayush Pharmacies and Drug Testing Laboratories to
achieve higher standards.
16. 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.
(b) The Ministry of Ayush is 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 and
(iii) Ayurveda Biology Integrated Health Research added under the scheme from FY 2023-
24. Under the Research & Innovation in Ayush component, financial assistance is provided to
the eligible Organizations/Institutions across the county as per the provision contained in the
scheme guidelines to support clinical, fundamental, pharmaceutical, literary and medicinal
plant research in Extra Mural mode.
Government of India has established Central Council for Research in Ayurvedic
Sciences (CCRAS), Central Council for Research in Unani Medicine (CCRUM), Central
Council for Research in Homoeopathy (CCRH), Central Council for Research in Siddha
(CCRS) and Central Council for Research in Yoga & Naturopathy (CCRYN) 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 in-vitro propagation techniques, Drug Standardization, Pharmacological
Research, Clinical Research, Literary Research and Documentation and Tribal Health Care
Research Programme.
******************
2