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Recombinant Pharma: move to implement report welcomed

Special Correspondent

CII says it will rationalise and simplify the regulatory approval procedure

NEW DELHI: The Confederation of Indian Industry has welcomed the decision of the Ministry of Environment and Forests to implement the recommendations of the Mashelkar Task Force on Recombinant Pharma from April 1.

The move would 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, a CII statement said on Saturday. The Government had taken serious note of long-standing concerns of the industry and decided to implement the recommendations of the task force, which included industry nominees and representatives of government bodies.

Graded scrutiny system

The proposed new system clearly separated different scenarios based on their risk potential and created a graded system of scrutiny with a more detailed assessment for product categories where the risk concern was higher. The earlier system caused a lot of overlapping responsibilities among different bodies and duplication of work.

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