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

Description
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.

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Definitions
Pharmacovigilance
(Source: https://ayush.gov.in/resources/pdf/schemes/aoushdhi.pdf)

Benefits
• **Safety Monitoring and Public Health Protection:** Establishes a national system for monitoring adverse drug reactions of ASU&amp;amp;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.
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Eligibility Criteria
1. > **Eligible Organizations For Peripheral Pharmacovigilance Centres (PPvCs):**
2. - Ayush teaching hospitals recognized under NCISM/NCH Act, IMCC Act, HCC Act, or similar regulatory bodies.
3. - NABH accredited or Government ASU&amp;H healthcare facilities and research council healthcare institutions.
4. - Institutions with technical competence and infrastructure for safety monitoring and reporting.
5. - Institutions with credible outcomes in similar projects are preferred.
6. - Institutions that previously received Central Government funding must have settled utilization certificates and no adverse remarks.
7. > **Eligible Organizations For Intermediary and National Centres:**
8. - Institutions designated by the Ministry of Ayush as National or Intermediary Pharmacovigilance Centres.
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Application Process
Step 1: Step 1: Visit the Ayush NGO Portal.
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Step 1: Visit the Ayush NGO Portal.

Step 2: Step 2: Fill in all the mandatory details and upload the relevant documents.
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Step 2: Fill in all the mandatory details and upload the relevant documents.

Step 3: Step 3: Verify the captcha and click on "Register". If required, click "Cancel" to discard changes.
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Step 3: Verify the captcha and click on "Register". If required, click "Cancel" to discard changes.

Step 4: Step 1: Visit the Ayush NGO Portal.
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Step 1: Visit the Ayush NGO Portal.

Step 5: Step 2: Enter the registered email id, password.
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Step 2: Enter the registered email id, password.

Step 6: Step 3: Type the captcha and click on "Login".
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Required Documents
• Application form and concept note for participation as PPvC.
• Undertaking to comply with pharmacovigilance norms and reporting requirements.
• Details of existing infrastructure, manpower, and equipment.
• Project proposal including objectives, action plan, milestones, and budget breakup.
• Recommendation letter from the head of the institution.
• Utilization certificates of previous Government-funded projects (if applicable).
• Any other documents as required.

Frequently Asked Questions
Q: What is the objective of the "Pharmacovigilance of ASU&H Drugs Including Surveillance of Misleading Advertisements" scheme-component?
A: The component aims to establish a national safety monitoring system and surveillance mechanism for misleading advertisements related to ASU&amp;H drugs.
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Q: What is pharmacovigilance in ASU&H drugs?
A: Pharmacovigilance is the systematic monitoring of adverse drug reactions and other safety-related issues associated with Ayurveda, Siddha, Unani and Homoeopathy drugs.
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Q: Who implements the pharmacovigilance programme?
A: The programme is implemented by the Ministry of Ayush through the National Pharmacovigilance Co-ordination Centre and its associated centres.
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Q: What is the structure of the pharmacovigilance system?
A: The system follows a three-tier structure comprising the National Pharmacovigilance Co-ordination Centre, Intermediary Pharmacovigilance Centres, and Peripheral Pharmacovigilance Centres.
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Q: Which institutions can become Peripheral Pharmacovigilance Centres?
A: Ayush teaching hospitals, accredited healthcare facilities, and Government or Research Council healthcare institutions with adequate infrastructure and expertise can become PPvCs.
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Q: What activities are supported under this component?
A: The component supports ADR reporting, surveillance of misleading advertisements, awareness programs, research activities, and data analysis.
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Q: How is misleading advertisement surveillance conducted?
A: Reports on misleading advertisements are collected from practitioners, consumers, industry stakeholders, and healthcare institutions and reviewed for regulatory action.
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Q: What type of financial assistance is provided?
A: Financial assistance is provided for manpower, awareness programs, IEC materials, contingency expenses, and programme management at different pharmacovigilance centres.
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Q: How are proposals evaluated?
A: Proposals are reviewed by the Intermediary Centre and evaluated by the National Pharmacovigilance Co-ordination Centre before approval by the Ministry of Ayush.
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Q: Is prior Government funding a disqualification?
A: No, institutions that received previous Government funding are eligible, provided utilization certificates are settled and there are no adverse remarks.
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Q: What are the responsibilities of a Peripheral Pharmacovigilance Centre?
A: PPvCs are responsible for reporting adverse drug reactions, monitoring misleading advertisements, and coordinating with Intermediary Centres.
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Q: How are funds released to selected centres?
A: Funds are released periodically based on progress reports and audited statements of expenditure submitted to the NPvCC.
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Q: Why is this scheme important for public health?
A: The scheme ensures the safety and reliability of ASU&amp;H drugs and protects consumers from unsafe medicines and misleading claims.
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