Explain the status and central sector scheme of pharmacovigilance for Ayurveda, Siddha, Unani and Homeopathy, ASU and H drugs.
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Pharmacovigilance Programme for ASU&H drugs Ayurveda Siddha Unani Homeopathy central sector scheme status
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PvPI ASU&H Ministry of AYUSH central sector scheme pharmacovigilance objectives
Reading Web Page
https://www.pib.gov.in/PressReleasePage.aspx?PRID=1542977
Reading Web Page
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2080167
Pharmacovigilance Programme for ASU&H Drugs (Ayurveda, Siddha, Unani and Homoeopathy)
Background
Quality and safety concerns around Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs, along with misleading advertising claims made for these products, prompted the Ministry of AYUSH (Government of India) to formalize a nationwide system for monitoring adverse drug reactions (ADRs) in traditional medicine, mirroring what the Pharmacovigilance Programme of India does for allopathic drugs under CDSCO.
The Central Sector Scheme
The Central Sector Scheme for Promoting Pharmacovigilance of ASU&H Drugs was approved by the Standing Finance Committee (chaired by the Secretary, AYUSH) on 1 November 2017 and rolled out near the end of FY 2017-18. Its prime objectives are to:
- Develop a culture of documenting adverse effects and undertake systematic safety monitoring of ASU&H drugs
- Collect, collate and analyze ADR data to build scientific, evidence-based clinical safety profiles for these systems of medicine
- Conduct surveillance of objectionable or misleading advertisements appearing in print and electronic media and refer them to State Licensing Authorities for regulatory action
The scheme was designed with the Central Drugs Standard Control Organisation (CDSCO) as the national drug regulatory authority and the Indian Pharmacopoeia Commission (IPC), WHO's Collaborating Centre for Pharmacovigilance, acting as mentors/technical guides.
Currently, this Pharmacovigilance Programme functions as one component of a broader umbrella scheme, Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY), which also covers strengthening of Drug Testing Laboratories (34 State Drug Testing Laboratories supported; 106 laboratories licensed under the Drugs and Cosmetics Rules, 1945 for ASU quality testing).
Organizational Structure (Three-Tier Network)
The programme runs through a three-tier pyramid of centres spread across the country:
| Tier | Centre | Role |
|---|---|---|
| National | 1 National Pharmacovigilance Coordination Centre (NPvCC) | Apex coordination, national database, signal analysis |
| Intermediary | 5 Intermediary Pharmacovigilance Centres (IPvCs) | Regional coordination and quality checking of reports |
| Peripheral | 99 Peripheral Pharmacovigilance Centres (PPvCs) | Frontline ADR collection at hospitals/institutions |
Historically, an earlier structure known as the National Pharmacovigilance Resource Centre for Ayurveda, Siddha and Unani drugs (NPRC-ASU) was set up under a preceding Central Sector scheme to build this network from the ground up (Baghel MS, Int J Ayurveda Res 2010).
Reporting Mechanism
Consumers, practitioners and manufacturers can report ADRs or objectionable advertisements either directly to a Peripheral Pharmacovigilance Centre or through the online AYUSH Suraksha portal:
Reports of misleading advertisements are forwarded systematically to the respective State Licensing Authorities for enforcement action, with penalty provisions available under the Drugs and Cosmetics Act/Rules against defaulters marketing unsafe or falsely advertised ASU&H medicinal substances.
Regulatory Backing (Current Status)
Pharmacovigilance is no longer just a voluntary scheme component - it has been made a mandatory regulatory requirement:
- Under the National Commission for Indian System of Medicine Regulations, 2022
- Under the National Commission for Homoeopathy Regulations, 2022
Both regulations require pharmacovigilance reporting as a mandatory component for practitioners and institutions across all AYUSH systems of medicine.
Supporting apex research infrastructure includes the Central Council for Research in Ayurvedic Sciences (CCRAS), Central Council for Research in Unani Medicine (CCRUM), Central Council for Research in Homoeopathy (CCRH), Central Council for Research in Siddha (CCRS) and Central Council for Research in Yoga & Naturopathy (CCRYN), all under the Ministry of AYUSH.
Summary of Status
- Scheme approved: 1 November 2017; operational since late FY 2017-18
- Now embedded within the larger AOGUSY central sector scheme
- Network: 1 National + 5 Intermediary + 99 Peripheral centres nationwide
- Reporting portal: AYUSH Suraksha (suraksha.ayush.gov.in / ayushsuraksha.com)
- Made a statutory/mandatory requirement via 2022 National Commission regulations for Indian Systems of Medicine and Homoeopathy
- Mentored technically by CDSCO and the Indian Pharmacopoeia Commission (WHO Collaborating Centre for Pharmacovigilance)
Sources: Ayush Suraksha portal, PIB press release, 14 Aug 2018, PIB press release on AOGUSY, AyushSuraksha - Pharmacovigilance, Baghel MS, "The National Pharmacovigilance Program for Ayurveda, Siddha and Unani Drugs: Current status," Int J Ayurveda Res 2010.
Note: my medical textbook library (largely Western/allopathic clinical texts, e.g. Park's Textbook of Preventive and Social Medicine) does not carry a dedicated section on the ASU&H scheme itself, so the above is drawn from official Ministry of AYUSH/PIB sources and the peer-reviewed literature cited. If you want, I can also pull specific ADR statistics or recent PvPI-ASU&H annual report data via PubMed/CCRAS publications.
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