Context
Recently, the union Minister of State for Ayush informed the Rajya Sabha about the Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana.
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- Under Rule 158 B of The Drugs Rules, 1945, guidelines for issue of license and requirement of safety study and Experience/Evidence of effectiveness with respect to Ayurveda, Siddha or Unani drugs have been prescribed.
- Manufacturers must comply with licensing requirements for units and medicines, including proof of safety and effectiveness, and adhere to Good Manufacturing Practices (GMP) as per Schedule T and M-I of The Drugs Rules, 1945.
- Rule 159 of The Drugs Rules, 1945 have provisions for cancellation or suspension of licenses if the licensee has failed to comply with any of the conditions of the license.
- Rule 160 A to J The Drugs Rules, 1945 provides the regulatory guidelines for approval of Drug Testing Laboratory for carrying out tests of identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs.
About Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana
- The scheme intends to promote and project quality, acceptability and visibility of Ayush products for enhancing people’s confidence in their use for health care and for improving trade.
- It is a Central Sector Scheme formulated by the Ministry of Ayush.
- It seeks to regulate Ayurveda, Siddha, Unani, and Homeopathy (ASU&H) medicines in India, using the framework established by the Drugs & Cosmetics Act of 1940.
- Components:
- Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards.
- Pharmacovigilance of ASU&H drugs including surveillance of misleading advertisements.
- Strengthening of Central and State regulatory frameworks including Technical Human Resource & Capacity Building programs for Ayush drugs.
- Support for development of standards and accreditation/ certification of Ayush products & materials in collaboration with BIS, QCI and other relevant scientific institutions and industrial R&D centres.
- DURATION OF THE SCHEME:
- The Scheme is currently valid up to 31.03.2026 and would be extended further after approval of the SFC.
