AOGUSYPCVASMA

The scheme-component aims to establish a robust safety monitoring and surveillance system for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs and to monitor misleading advertisements related to Ayush medicines.

The scheme-component "Pharmacovigilance of ASU&H Drugs Including Surveillance of Misleading Advertisements" under the "Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana" implemented by the Ministry of Ayush, Government of India, aims to to collect, collate and analyze data to establish evidence for clinical safety of the ASU&H drugs in a scientific manner for documenting clinical evidences of safety of these drugs and undertake surveillance of advertisements of these drugs or on these system of medicines.

Pharmacovigilance initiative for ASU&H drugs aims at-

• inculcating the reporting culture among the consumers as well as ASU&H practitioners to facilitate documentation of Adverse Drug Reactions (ADRs) and instances of misleading advertisements of Ayurveda, Siddha, Unani & Homoeopathy drugs;
• developing a system-wise database of Adverse Drug Reactions of ASU & H drugs; and
• evolving evidence based recommendations regarding the clinical safety and improper advertisements of ASU&H drugs for regulatory actions.

> Eligible Organizations For Peripheral Pharmacovigilance Centres (PPvCs):

• Ayush teaching hospitals recognized under NCISM/NCH Act, IMCC Act, HCC Act, or similar regulatory bodies.
• NABH accredited or Government ASU&H healthcare facilities and research council healthcare institutions.
• Institutions with technical competence and infrastructure for safety monitoring and reporting.
• Institutions with credible outcomes in similar projects are preferred.
• Institutions that previously received Central Government funding must have settled utilization certificates and no adverse remarks.

> Eligible Organizations For Intermediary and National Centres:

• Institutions designated by the Ministry of Ayush as National or Intermediary Pharmacovigilance Centres.

• Safety Monitoring and Public Health Protection: Establishes a national system for monitoring adverse drug reactions of ASU&H drugs. - Surveillance of Misleading Advertisements: Strengthens regulatory oversight to detect and act against misleading claims in Ayush drug advertisements. - Capacity Building and Awareness: Supports training programs, workshops, and awareness campaigns for practitioners and consumers. - Financial Support for Pharmacovigilance Centres: Provides recurring and non-recurring financial assistance to NPvCC, IPvCs, and PPvCs for manpower, IEC materials, and contingency expenses. - Evidence-Based Regulatory Action: Generates scientific evidence on drug safety to support regulatory decisions and policy formulation.