Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (2025)

Policy Update
Atharva Salunke

Background:

Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY), which was launched in 2021 by the Ministry of Ayush, is a Central Sector Scheme. The scheme is aimed at upgrading the quality benchmark of Ayurveda, Siddha, Unani, and Homoeopathy (ASU&H) drugs. India has a massive network of more than 8,000 licensed manufacturers in the industry, most of whom are small and medium enterprises struggling with infrastructure, embracing foreign technology, and regulatory issues. As domestic and international demand for Ayush products picked up, there was a need to enhance the capability of the industry to meet international quality standards and ensure consumer safety.

The program was contemplated through the integration of existing schemes such as Pharmacovigilance, Central Drug Controller of Ayush, and Quality Control components of the National Ayush Mission, with fresh initiatives towards regulatory strengthening, research, certification, and capacity building. The program is centered on Good Manufacturing Practices (GMP), in-house testing laboratories, stability tests, and compliance with the pharmacopoeial standards of purity, strength, and tolerable contaminants. With a total financial investment of ₹122 crore over five years (2021-2026), AOGUSY plans to enable manufacturers to adopt newer technologies, enhance quality control procedures, and help Ayush products gain international recognition.

Objectives as per official guidelines issued:

1. To enhance India’s manufacturing capabilities and exports of traditional medicines and health promotion products under the initiative of Atmanirbhar Bharat.
2. To facilitate adequate infrastructural & technological upgradation and institutional activities in the public and private sector for standardization, quality manufacturing, and analytical testing of Ayush drugs & materials.
3. To strengthen regulatory frameworks at the Central and State levels for effective quality control, safety monitoring, and surveillance of misleading advertisements of Ayush drugs.
4. To encourage building up synergies, collaborations, and convergent approaches for promoting standards and quality of Ayush drugs & materials.

Functioning:

The Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) operates through a systematic mechanism to ensure transparency and accountability in project implementation. Proposals from candidates who meet the eligibility criteria from Ayush pharmacies, drug testing laboratories, research councils, and private manufacturers are solicited on a half-yearly basis. Proposals are scrutinized by the Project Appraisal Committee (PAC), consisting of specialists from the Ministry of Ayush, CDSCO, BIS/QCI, and research councils. Following technical and cost evaluation, the PAC identifies appropriate projects to be suggested to the Project Sanctioning Committee (PSC), with the Secretary, Ministry of Ayush, as its chairperson, taking decisions on final sanction and funding.

The scheme is being implemented through a Program Management Unit (PMU) at the Ministry level for coordination, monitoring, and reporting. Site visits and progress verification are carried out by Monitoring Committees with members from the Ministry, State Governments, and research organizations. Release of funds is made in installments by PFMS based on utilization certificates and deliverables. The multi-level approach enables proper implementation of infrastructure upgradation, pharmacovigilance, strengthening of regulations, and product certification goals towards improving quality levels in the Ayush sector.

Components of AOGSUY:

1. Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards. 
2. Pharmacovigilance of Ayurveda, Siddha, Unani, and Homoeopathy (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 the development of standards and accreditation/certification of Ayush products & materials in collaboration with the Bureau of Indian Standards (BIS), Quality Control of India (QCI), and other relevant scientific institutions and industrial R&D centres.

Table 1: Beneficiaries and Benefits under the AOGUSY Scheme

3. Performance:
4. Under the first component of AOGUSY, the Ministry of Ayush has extended financial support to 16 ASU&H pharmacies and 6 ASU&H drug testing laboratories to help them achieve higher standards.

Table 2: Incentives for Strengthening and Upgrading of Ayush Pharmacies and Drug Testing Laboratories

2. In the second part of the scheme, the Ministry of Ayush introduced a Pharmacovigilance Programme for ASU&H drugs. It runs on a three-tier system spread across the nation with one National Pharmacovigilance Coordination Centre (NPvCC), five Intermediary Pharmacovigilance Centres (IPvCs), and 97 Peripheral Pharmacovigilance Centres (PPvCs). The AIIA, New Delhi, has been designated as the NPvCC to implement this scheme concerning its components on Ayurveda, Siddha, Unani, and Homoeopathy medicines. These centres look out for false advertising and report it to the concerned State Regulatory Authorities for necessary action against defaulters. In addition, the program keeps documenting and reporting suspected cases of Adverse Drug Reactions (ADRs) pertaining to ASU&H medicines on an ongoing basis.

1. Over the last five years, the Pharmacovigilance Program has placed strong emphasis on spreading awareness regarding drug safety and adverse event reporting. A total of 2,753 awareness programs were conducted between 2021 and June 2025, reaching more than 2.52 lakh beneficiaries. These programs have targeted a wide range of stakeholders, including practitioners, manufacturers, healthcare professionals, and the general public, to build a culture of safe use and monitoring of ASU&H drugs.

Table 3: Awareness Programs Conducted under the Pharmacovigilance Program (2021-2025)

2. The submission of Suspected Adverse Drug Reactions (ADRs) continues to be a fundamental aspect of the Pharmacovigilance program. Over the period of five years, 2,007 suspected ADRs were reported. These submitted reports form important evidence to determine the safety of ASU&H drugs and to inform the regulatory action. A record number of cases were submitted in the year 2024, with 521 suspected ADRs.

Table 4: Reported Suspected Adverse Drug Reactions (ADRs) under the Pharmacovigilance Program

3. The program has also actively monitored misleading advertisements of ASU&H drugs, which pose risks to consumer safety and the credibility of the sector. Between 2021 and June 2025, a total of 40,140 misleading advertisements were identified and reported to State Regulatory Authorities for corrective action. This included advertisements flagged during the COVID-19 period, when false claims were particularly high.

Table 5: Surveillance of Misleading Advertisements under the Pharmacovigilance Program

3. As part of the third component of the AOGUSY Scheme, three training programs have been organized for Ayush drug regulators, industry personnel, and other stakeholders.

4. The fourth element of the AOGUSY Scheme focuses on establishing strong standards, certification frameworks, and mechanisms for quality assurance for Ayurveda, Siddha, Unani, Sowa-Rigpa, and Homoeopathy (ASU&H) medicines.

The legal basis is the Drugs & Cosmetics Act, 1940, and the Drugs Rules, 1945, requiring Good Manufacturing Practices (GMP) under Schedule T and Schedule M-I. Drug Inspectors make periodic collections of samples from manufacturers and distributors, legal action being taken where products are “Not of Standard Quality”.

The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) has a central role to play in establishing pharmacopoeial standards and formulary specifications. So far, 2,269 quality standards of raw materials, 426 of formulations, and 2,799 formulary specifications have been brought out. As the Central Drugs Laboratory for ASU&H medicines, PCIM&H also provides capacity-building training to regulators, testing laboratories, and industry players.

Further, Drug Testing Laboratories (DTLs) are also acknowledged under Rule 160 A–J of the Drugs Rules, 1945. There are currently 108 private labs and 34 State/UT labs working on official testing of drug quality.

The Pharmacovigilance Program adds to these by tracking adverse drug reactions and deceptive advertising, and the newly introduced Ayush Suraksha portal (May 2025) allows professionals and the public to report and monitor ADRs and objectionable ads in real time.

Impact:

The AOGUSY program and related programs have significantly improved quality control and safety surveillance of ASU&H drugs. Upgrading of infrastructure and grant support has allowed laboratories and pharmacies to achieve superior manufacturing and test standards, while releasing pharmacopoeial specifications has harmonized quality standards. Widespread awareness campaigns and capacity development have enhanced stakeholders’ participation and reporting of adverse events, enhancing pharmacovigilance information. Active monitoring and reporting of deceptive advertisements, enabled by the Ayush Suraksha portal, have improved regulatory compliance and consumer protection. These efforts collectively strengthen public trust, enable ease of compliance with national and international standards, and establish market growth and export conditions.

Emerging Issues:

Implementation is progressing smoothly with no significant issues reported; activities, upgrades, and monitoring are proceeding as planned, successfully reflecting effective coordination, timely execution, and strong stakeholder engagement across all components.

Way Forward:

It is recommended that the AOGUSY Scheme be continued in the next cycle to consolidate achievements, ensure sustained quality enhancement, expand pharmacovigilance coverage, strengthen regulatory frameworks, and promote global competitiveness of Ayush medicines.

References:

1. Government of India, Ministry of Ayush. (n.d.). The central sector scheme for augmenting quality of AYUSH drugs: AYUSH Oushadhi Gunvatta Evam Utpadan Samvardhan Yojana (AOGUSY). Drug Policy Section, Ministry of Ayush. https://ayush.gov.in/resources/pdf/schemes/aoushdhi.pdf
2. Government of India, Ministry of Ayush. (2025, August 8). AYUSH Aushadhi Gunvatta Evam Uttpadan Samvardhan [Unstarred Question No. 3334, Lok Sabha]. https://sansad.in/getFile/loksabhaquestions/annex/185/AU3334_Qx4Iab.pdf?source=pqals
3. Press Information Bureau. (2025, August 1). Promotion of AYUSH system of medicine. PIB Delhi. https://www.pib.gov.in/PressReleseDetailm.aspx?PRID=2151296
4. Press Information Bureau. (2024, December 17). Government supporting the growth of the Ayurveda products market: Ayush industry reaches $18.1 billion (2020–21). PIB Delhi. https://www.pib.gov.in/PressReleaseIframePage.aspx?PRID=2085331
5. Press Information Bureau. (2024, December 3). Pharmacovigilance program for ASU&H drug is one of the components of the central sector scheme–Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY). PIB Delhi. https://www.pib.gov.in/PressReleseDetailm.aspx?PRID=2080167

About the Contributor:

Atharva Salunke is a Policy Research Associate at NITI TANTRA and a Research Intern at IMPRI. He has recently graduated with a Bachelor’s degree in Political Science from Sir Parashurambhau College, Pune.

Acknowledgement: The author extends his sincere gratitude to the IMPRI team and Ms. Aasthaba Jadeja for her invaluable guidance throughout the process.

Disclaimer: All views expressed in the article belong solely to the author and not necessarily to the organisation.

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