New scheme for monitoring drugs safety aspects

New Delhi: The AYUSH Ministry introduced a new central sector scheme for monitoring of the safety aspects of Ayurveda, Siddha, Unani and Homoeopathy drugs and documenting their adverse effects.

The ministry introduced the scheme for promoting pharmacovigilance of these drugs.

“The 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,” it said.

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), an official statement said.

All India Institute of Ayurveda, New Delhi, an autonomous body under the AYUSH Ministry, was designated as the National Pharmacovigilance Centre for coordinating various activities under the initiative.

In the initial phase of implementation, five national institutes of AYUSH are designated as the Intermediary Pharmacovigilance Centres and 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 such drugs.

The scheme was rolled out for implementation in the country near the end of financial year 2017-18. It is intended to have more such centres across the country and achieve the target of 100 peripheral pharmacovigilance centres by 2020.

The government in the first instance has sanctioned a 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.

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.

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