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New scheme for promoting Pharmacovigilance of AYUSH Drugs

AYUSH

New Delhi: 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 Ayurveda, Siddha, Unani and Homoeopathy drugs and surveillance of misleading advertisements appearing in the print and electronic media.

The Standing Finance Committee (SFC) chaired by Secretary (AYUSH) approved the scheme on 1st November, 2017 and thereafter it was rolled out for implementation in the country near the end of financial year 2017-18.

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.

In the initial phase of implementation, five (05) National Institutes of AYUSH are designated as the Intermediary Pharmacovigilance Centres and forty two (42) institutions of AYUSH having clinical facilities as Peripheral Pharmacovigilance Centres to take up the work of reporting, documentation, analysis, causality assessment of the adverse reactions and events associated with the consumption of Ayurveda, Unani, Siddha and Homoeopathy drugs.

It is intended to have more such centres across the country and achieve the target of 100 peripheral pharmacovigilance centres by 2020. Government in the first instance has sanctioned grant of Rs 10.60 crore to All India Institute of Ayurveda, New Delhi to establish the proposed pharmacovigilance network and steer implementation of the initiative with standard protocol and reporting format, training of coordinators & nodal officers, constitution of various committees and systematic reporting of the progress.

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.

The quality issues and safety concerns of Ayurveda, Siddha, Unani and Homoeopathy Drugs have been raised from various sources. Ministry of AYUSH 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.

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