The Government has undertaken several measures to strengthen quality assurance and regulatory compliance of Ayush drugs, including those made available through digital commerce platforms.

The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurvedic, Siddha, Sowa-Rigpa, Unani, and Homoeopathy (ASSU&H) drugs. It is mandatory for the manufacturers to adhere with the prescribed requirements for license to manufacture for sale including proof of safety & effectiveness, compliance with Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of the Drugs Rules, 1945 for Ayurvedic, Siddha, Sowa-Rigpa, Unani & Homeopathy drugs respectively and also to follow the quality standards of drugs as prescribed in the respective pharmacopoeia. Drug Inspectors of the concerned State/UTs collect medicine samples regularly from manufacturing firms or retail shops within their jurisdiction and send them to Drug Testing Laboratory 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 Ayush drugs from the market and appropriate legal actions as per Drugs and Cosmetics Act, 1940 and Rules made thereunder.

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 with Global standards. Drug Inspectors posted in Ayush vertical, regularly conduct joint inspections of manufacturing units along with drug inspectors of State/UTs and CDSCO to ensure the safety and quality of Ayush medicines.

Quality Certifications Scheme implemented by the Quality Council of India (QCI) for grant of Ayush Standard and Ayush Premium mark to ASU drugs on the basis of third-party evaluation of quality in compliance with domestic and international standards respectively.

Further, Ministry of Ayush is implementing a Central Sector Scheme namely, Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY) with the objectives of promoting standardization, quality manufacturing, analytical testing, strengthening regulatory frameworks, safety monitoring and surveillance of misleading advertisements. Under the Scheme, support is being provided to Ayush manufacturers (Government and Private), including MSMEs for strengthening and upgradation of Ayush pharmacies and Drug Testing Laboratories (DTLs) to achieve higher standards like WHO-GMP & NABL respectively. The Pharmacovigilance Programme for ASU&H drugs under AOGUSY scheme functions through a nationwide three-tier network comprising 01 National Pharmacovigilance Co-ordination Centre (NPvCC), 05 Intermediary Pharmacovigilance Centres (IPvCs), and 97 Peripheral Pharmacovigilance Centres (PPvCs). In addition, Ministry has launched the Ayush Suraksha Portal for real-time reporting and monitoring of misleading advertisements and suspected adverse drug reactions. Further, the Coordinator, National Pharmacovigilance Coordination Centre (NPvCC), All India Institute of Ayurveda, has been designated as the nodal officer under IT Act, 2000 for issuing notices to digital intermediaries in respect of Misleading/Objectionable advertisements relating to Ayush drugs.

Additionally, the Central Consumer Protection Authority (CCPA) has issued an Advisory to e-commerce entities regarding the sale of Ayurvedic, Siddha and Unani drugs containing ingredients specified in Schedule E(1) of the Drugs Rules, 1945. E-commerce platforms have been advised to facilitate the sale of such drugs only after the user uploads a valid prescription issued by a registered Ayurveda, Siddha or Unani medical practitioner, as applicable.

Ministry of Ayush has launched Ayush Quality Mark (AQM) initiative through the Ayush Export Promotion Council (AYUSHEXCIL). Under this framework, the Ayush Quality Mark is being granted after scrutiny and verification of valid quality certifications and statutory approvals issued by the competent Government authorities, such as GMP, WHO-GMP, Ayush Premium Mark and other recognised certifications, as applicable. The initiative aims to strengthen quality assurance, enhance consumer confidence, and improve the credibility and global competitiveness of Indian Ayush products.

The Ministry has taken several steps to promote dissemination of verified information on Ayush products and systems through advisories, websites, social media handles and public notices. Further, all Research Councils and National Institutes under ministry of Ayush disseminate evidence-based information on Ayush products and systems through Information, Education and Communication (IEC) activities, publications, journals, outreach programmes, electronic and print media, and digital platforms.

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

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