Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY): Pharmacovigilance of ASU&H Drugs Including Surveillance of Misleading Advertisements

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.

• 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.

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.

Offline

• Submission of Concept Note: The applicant institution submits a concept note and proposal to the concerned Intermediary Pharmacovigilance Centre (IPvC). - Forwarding of Proposal: The proposal must be forwarded with a recommendation from the head of the applicant institution. - Review by Intermediary Centre: The Intermediary Pharmacovigilance Centre reviews the proposal and forwards it with comments to the National Pharmacovigilance Co-ordination Centre (NPvCC).
• Evaluation by NPvCC: The NPvCC examines the proposal for suitability and eligibility. - Approval by Project Sanctioning Committee: Upon approval by the Ministry of Ayush Project Sanctioning Committee, the institution is declared a Peripheral Pharmacovigilance Centre. - Release of Funds: Financial assistance is released periodically based on progress reports and audited statements of expenditure.

Online

Registration Process:

Step 1: Visit the Ayush NGO Portal.
Step 2: Fill in all the mandatory details and upload the relevant documents.
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