BACKGROUND: Regulation of Ayurveda, Siddha, Unani and Homoeopathic (ASU&H) medicines in India, are governed under the provisions of Drugs & Cosmetics Act, 1940 and the Rules made there under. The growth & development of traditional Indian and Homoeopathic medicines in the interest of public health is expected within the objective of making accessible, safe, effective and quality medicines to the people. Emerging global developments in the area of drug regulatory compliance are incorporated for ASU&H medicines in accordance with the national health circumstances and regulatory needs of standardization & quality control, research & development of ASU&H drugs.
Country has approximately more than 8000 licensed Ayurvedic, Siddha, Unani and Homoeopathy drugs manufacturers. Most of them are small and medium scale entrepreneurs with inadequate capacities and avenues for growth. Regulatory requirements and emerging demand for quality Ayush products need adequate investment towards infrastructural facilities and quality control systems for production of Ayush products in the domestic and international markets. Considering the range and scope of Ayush products in national and international markets and the strategic steps needed for mainstreaming of Ayush drug industry, it is envisaged to support the manufacturers in their efforts for adopting quality production technology, in-house quality control facilities etc.
With this background, Ministry of Ayush, Government of India has accordingly initiated the Central Sector Scheme for augmenting quality of Ayush drugs during the 15th Finance Cycle (2021-22 to 2025-26) by merging the existing Central Sector Schemes of Pharmacovigilance initiative, Central Drug Controller of Ayush and Quality Control of ASU&H drugs (Component of National Ayush Mission (NAM)). This scheme is named as Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY).
VISION:
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.
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- To inculcate culture of quality production of Ayush products assured with safety and efficacy.
- To enable Ayush drug industry in complying with national and global regulatory requirements and standards.
- To build up visibility and demand- driven market presence of Ayush products.
- To strengthen Ayush pharmaceutical industry for enhancing trade and exports.
OBJECTIVES:
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- To enhance India’s manufacturing capabilities and exports of traditional medicines and health promotion products under the initiative of Atmanirbhar Bharat.
- To facilitate adequate infrastructural & technological upgradation and institutional activities in public and private sector for standardization, quality manufacturing and analytical testing of Ayush drugs & materials.
- To strengthen regulatory frameworks at Central and State level for effective quality control, safety monitoring and surveillance of misleading advertisements of Ayush drugs.
- To encourage building up synergies, collaborations and convergent approaches for promoting standards and quality of Ayush drugs & materials.
COMPONENTS OF THE SCHEME:
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 BIS, QCI and other relevant scientific institutions and industrial R&D centres.
SALIENT FEATURES:
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- It is a central sector scheme.
- Implementation: The Scheme would be implemented, managed, monitored and operationalized by the Program Management Unit (PMU), established in the Drug Policy Section, Ministry of Ayush.
- Monitoring mechanism: The status of project implementation will be verified by a Monitoring Committee constituted by the Ministry of Ayush consisting of representatives of Ministry of Ayush, and/or State Government, and Central Ayush Research Council.
