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Policy Matters

Dept of Ayush plans to support effectiveness studies of 500 select ASU drugs for better global recognition

New Delhi (PB): The Department of Ayush may initiate a scheme to support biological activity and effectiveness studies of 500 select Ayurveda, Siddha and Unani (ASU) medicines so that they get a wider acceptance in the international markets and as part of further streamlining the regulations and standards in the sector.

The Steering Committee of the Planning Commission had made recommendations for supporting shelf life studies, development of phyto-chemical marker compounds, safety studies, biological activity studies and efficacy/effectiveness of 500 ASU drugs. The proposal is being pursued with the Planning Commission for approval, sources in the department said.

Other recommendations of the panel included development of new scientific monographs and revision of already published monographs, selection of priority drugs with high market potential by the Pharmacopoeia Commission of Indian Medicine and development of Ayush drug dossiers to facilitate entry of Ayush drugs in the international market.

Elaborating on the specific achievements of the Department in the last five years in the regulatory areas, an official of the Department said three national institutes and a Pharmacopoeia Commission of Indian Medicine have been/are being set up.

Publication of pharmacopoeial standards and Standard Operating Procedures (SOPs) of 152 ayurvedic formulations, publication of pharmacopoeial monographs of 101 single plant drugs and 21 minerals, publication of macro and microscopic and TLC atlases of 172 drugs, and development of eight community herbal monographs in the format given by European Medicines Evaluation Agency (EMEA) for submission to European Union were the other highlights of the performance.

The Steering Committee of the Planning Commission also had recommended Rs.50 crore towards the activities in the regulatory area for the current Five Year Plan. The amount was sought for augmenting pharmacopoeia work to develop 1000 monographs and strengthening Pharmacopoeia Commission and associated laboratories to accelerate the work of standardization and quality parameters of ASU drugs as per global requirements and acceptability, to take up development of monographs of such medicinal plants as are widely used in folklore/tribal medicine but not documented in ASU literature and to work on the lines of other Pharmacopoeia Commissions of the world.


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