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CII welcomes implementation of Mashelkar Committee Report

Written by: Staff

New Delhi, Apr 2 (UNI) The Confederation of Indian Industries (CII) today welcomed the announcement by the Ministry of Environment and Forests regarding the implementation of the recommendations of the Mashelkar Task Force on Recombinant Pharma from April 1,2006.

In a release issued here CII said the implementation will considerably rationalise and simplify the regulatory approval procedure without diluting the stringency of scrutiny of the safety and efficacy data as well as environmental safety considerations.

It is laudable that the government has taken serious note of long standing concerns of the industry and decided to implement the recommendations of the Task Force that included several industry nominees in addition to representatives and heads of different government bodies, the industry chamber said.

The release said the proposed new system clearly separates different scenarios based on their risk potential and creates a graded system of scrutiny with a more detailed assessment for product categories where the risk concern is higher.

It added that the earlier system had caused a lot of overlapping responsibilities among different bodies, and duplication of work whereas the new system will allow each body to focus on its core area of evaluation (biological safety, environmental safety, drug efficacy,etc.) and also reduce the burden by removing unnecessary workload of these bodies.

CII also expressed its approval that the clarity on regulations for emerging areas like contract research and manufacturing.

CII is particularly pleased that the government has committed to certain timelines for approvals at different stages which is the practice followed by regulatory bodies in developed countries according to the release.


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