The Task Force on Recombinant Pharma sector, constituted in 2004 by the Union ministry of environment and forests (moef), submitted its final report to moef on September 13, 2005. The team was entrusted with recommending a transparent and streamlined regulatory mechanism for the use of Living Modified Organisms (lmos) in the pharmaceutical industry. It has concluded that the regulatory objective of the Genetic Engineering Approval Committee should be confined to regulating from an environmental angle, only the proposals involving large-scale use of lmos. Product safety, efficacy, clinical trials, market authorisation and post-market surveillance should be the Drug and Controller General of India's concern.
The report points out that if the end product is an lmo, it can propagate/replicate in the environment and needs a higher level of regulation as compared to products that are derived from lmos but are not lmos themselves.
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