Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources
From UPSC perspective, the following things are important:
Prelims level: Particulars of the Scheme
Mains level: Read the attached story.
Scheme for Pharmacovigilance of ASU&H drugs
- Ministry of AYUSH has introduced new Central Sector scheme for promoting pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) Drugs.
- Prime objective of the scheme is to develop the culture of documenting adverse effects and undertake safety monitoring of ASUH drugs and surveillance of misleading advertisements appearing in the print and electronic media.
- The scheme intends to facilitate the establishment of three-tier network of National Pharmacovigilance Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCCs) and Peripheral Pharmacovigilance Centres (PPvCC).
- All India Institute of Ayurveda, New Delhi, an autonomous body under the Ministry of AYUSH, has been designated as National Pharmacovigilance Centre for coordinating various activities of the initiative.
Implementation of Scheme
- In the initial phase of implementation, five National Institutes of AYUSH are designated as the Intermediary Pharmacovigilance Centres.
- Another forty two institutions of AYUSH having clinical facilities are designated as Peripheral Pharmacovigilance Centres
- These will take up the work of reporting, documentation, analysis, causality assessment of the adverse reactions and events associated with the consumption of ASUH drugs.
- It is intended to have more such centres across the country and achieve the target of 100 peripheral Pharmacovigilance centres by 2020.
- Representatives of Central Drug Standards Control Organisation as the national drug regulatory authority and the Indian Pharmacopoeia Commission being the WHO Collaborating Centre for Pharmacovigilance in the country are associated in the initiative as mentor and guide.
Why such scheme needed?
- The quality issues and safety concerns of Ayurveda, Siddha, Unani and Homoeopathy Drugs have been raised from various sources.
- The Ministry felt it necessary in the interest of Public Health to oversee the impact of ASU&H Drugs consumed by the people from the perspective of their safety profile.
- Similarly, publicizing improper drug information in the form advertisements is a matter of concern that needs to be addressed to safeguard the interest of AYUSH drug consumers.
- Pharmacovigilance initiative will facilitate detection of potentially unsafe ASU&H medicines and misleading advertisements for taking regulatory action against them.