Ministry of Ayush is implementing a Central Sector Scheme Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana (AOGUSY) since 2021-22 with total budget outlay of Rs. 122.00 crores for five years. The components of scheme are as follows: -

1. Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards.
2. Pharmacovigilance of ASU&H drugs including surveillance of misleading advertisements.
3. Strengthening of Central and State regulatory frameworks including Technical Human Resource & Capacity Building programs for Ayush drugs.
4. Support for development of standards and accreditation/certification of Ayush products & materials in collaboration with Bureau of Indian Standards (BIS), Quality Control of India (QCI) and other relevant scientific institutions and industrial R&D centers.

The scheme has inter alia one of the component to strengthen and up-grade the Ayush Pharmacies and Drug Testing Laboratories (DTLs) to achieve higher standards like WHO-GMP and NABL, which ease the exports of Ayush drugs. Till date, 18 Ayush pharmacies and 07 Ayush DTLs have been supported financially under this scheme across the country. An amount of Rs. 40.13 crore has been sanctioned as Grant-in-Aid to these pharmacies and DTLs. The State/UT-wise details of fund released for the upgradation of Ayush pharmacies and Drug Testing Laboratories (DTLs) under the AOGUSY scheme till date are attached at Annexure.

Further, to strengthen Central and State regulatory frameworks, Ayush vertical in Central Drugs Standards Control Organization (CDSCO) and State Ayush Directorate/State Drug Controller of Ayush drugs are financially supported under AOGUSY Scheme for conducting training and capacity building programs.

The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy (ASSU&H) drugs.  It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units & medicines including proof of safety & effectiveness, compliance with the Good Manufacturing Practices (GMP) as per Schedule T and Schedule M of the Drugs Rules, 1945 for Ayurvedic, Siddha, Sowa-rigpa, Unani and Homeopathy drugs respectively and to follow the quality standards of drugs as prescribed in the respective pharmacopoeia.

Drug Inspectors collect medicine samples regularly from manufacturing firms or retail 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 medicines from the market and appropriate legal actions as per Drugs and Cosmetics Act, 1940 and Rules made thereunder. There are 34 Drug Testing Laboratories available in State/UTs for testing of the Legal Samples drawn by the Drug Inspectors of concerned State/UTs.

The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), a subordinate organization under Ministry of Ayush, develops pharmacopoeial standards and formulary specifications for Ayush drugs, which serve as the official compendia for determining their identity, purity, and strength. Compliance with these standards is mandatory under the Drugs and Cosmetics Act, 1940 and the Rules made thereunder. PCIM&H also functions as the Appellate Drug Testing Laboratory for Ayush drugs and conducts regular capacity-building programmes for Drug Regulatory Authorities, Drug Analysts, and other stakeholders on standardization, quality control, and testing methodologies to strengthen the quality assurance system for Ayush drugs.

Drug Testing Laboratories are approved by the Ministry of Ayush under Rules 160A to 160J of the Drugs Rules, 1945, for carrying out tests relating to the identity, purity, quality and strength of Ayush drugs. As on date, 118 private Drug Testing Laboratories have been approved by the Ministry across States and Union Territories for conducting such tests in accordance with the provisions of the Drugs Rules, 1945.

Further, Ministry of Ayush is implementing a Central Sector Scheme, namely, Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) to support Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards like WHO-GMP and NABL respectively.

In addition, the Ministry of Ayush has undertaken the following initiatives to promote quality assurance and certification of Ayush products:

• To strengthen regulatory oversight, Ayush Vertical in CDSCO facilitates the issuance of the World Health Organization Certificate of Pharmaceutical Product (WHO-CoPP) for eligible Ayush drugs through joint inspections with State/UT Licensing Authorities.
• Ayush Standard Mark and Ayush Premium Mark are awarded to Ayush Drugs by Quality Council of India (QCI) based on third-party assessment of compliance with prescribed national and international quality standards.
• Ayush Quality Mark Programme was launched by the Ministry of Ayush to strengthen quality assurance, enhance consumer confidence, and improve the Global recognition and competitiveness of Ayush products and services.

Annexure

The State/UT-wise details of fund released for the upgradation of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) pharmacies and Drug Testing Laboratories (DTLs) under the AOGUSY scheme till date, including Maharashtra, are as follows-

This information was given by Union Minister of State (I/C) for Ayush, Shri Prataprao Jadhav in a written reply in Lok Sabha today.

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SR/SV/SG