Question : TASK FORCE ON RECOMBINANT OF PHARMA SECTOR



(a) whether the Government has constituted a Task Force on Recombinant Pharma Sector for streamlining the procedures for Recombinant Pharma Industry;

(b) whether the said task force has submitted its final report to the Government;

(c) if so, the details thereof; and

(d) the measures taken by the Government to address the taxonomic issues?

Answer given by the minister

MINISTER OF STATE (INDEPENDENT CHARGE) OF THE MINISTRY OF SCIENCE & TECHNOLOGY AND MINISTER OF STATE (INDEPENDENT CHARGE) OF THE DEPARTMENT OF OCEAN DEVELOPMENT (SHRI KAPIL SIBAL)

(a) Yes Sir, the `Task Force on Recombinant Pharma Sector` under the Chairmanship of Director General,Council of Scientific & Industrial Research (DG, CSIR), New Delhi was constituted by the Ministry of Environment & Forests (MoE&F) in April, 2004.

(b)&(c) The Task Force has submitted its report to MoE&F in September, 2005. The Task Force has concluded in its report that the regulatory objective of Genetic Engineering Approval Committee (GEAC) should be confined to regulation of proposals, which involve the large-scale use of Living Modified Organisms (LMOs) from environmental angle; evaluation of the product safety, efficacy, clinical trials, market authorization and post market surveillance should be the mandate of the Drugs Controller General of India (DCGI); and has rationalized the regulatory procedure under five categories for the use of LMOs.

(d) There are no taxonomic issues involved in the mandate of the Task Force as per its terms of reference.