The Government of India is strengthening the regulatory and quality assurance framework for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs by upgrading drug testing laboratories and expanding the national pharmacovigilance network, according to the Ministry of Ayush.
The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), functioning under the Ministry, serves as the Appellate Drugs Testing Laboratory responsible for testing the identity, purity, quality and strength of ASU&H medicines. Approval of drug testing laboratories is governed by Rules 160 A to J of the Drugs Rules, 1945.
Under these provisions, infrastructure and functional capacity of 34 State Drug Testing Laboratories have been strengthened. A total of 108 laboratories are currently approved or licensed under the Drugs Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials. In addition, three regional research institutions of the Central Council for Research in Ayurvedic Sciences are approved for drug testing under Rule 160E.
Drug safety monitoring is being carried out through the Pharmacovigilance Programme for ASU&H drugs under the central sector scheme Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY). The programme operates through a three-tier structure comprising one National Pharmacovigilance Centre, five Intermediary Centres and 97 Peripheral Centres across the country. These centres monitor adverse drug reactions and misleading advertisements and report them to State Regulatory Authorities. Since inception, 3,533 awareness programmes have been conducted, reaching over 318,575 beneficiaries.
The Ministry of Ayush also promotes quality certification of ASU&H products through the WHO Certification of Pharmaceutical Product scheme administered by the Central Drugs Standard Control Organization and the Quality Council of India’s Ayush Mark certification based on third-party evaluation. AOGUSY, with a total outlay of ₹122 crore for the period 2021–22 to 2025–26, includes components for strengthening Ayush pharmacies and drug testing laboratories.
Regulation of ASU&H drugs is governed by specific provisions under the Drugs & Cosmetics Act, 1940 and the Drugs Rules, 1945, ensuring compliance with Good Manufacturing Practices and pharmacopoeial standards. PCIM&H formulates official pharmacopoeial and formulary standards for quality assessment. An Ayush vertical has also been established within the Central Drugs Standard Control Organization to coordinate inspections with state licensing authorities and drug inspectors.
The government is further strengthening research, human resource capacity and scientific validation of Ayush systems through initiatives such as the Ayurgyan Scheme, establishment of central research councils for Ayurveda, Unani, Siddha, Homoeopathy and Yoga & Naturopathy, and regular training programmes on standardisation and quality control for regulators, laboratory personnel and technical staff.
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