Biotechnology Products

A new set of recommendations for streamlining the regulatory process for the use of living Modified Organisms (LMOs) in the pharmaceutical industry during the various stages of R & D, testing, manufacture and import of LMOs as drugs was introduced from April 2006. This is an addition Rules for the Manufacture, Use, Import, And Export and Storage of Hazardous Micro Organisms Genetically Engineered Organisms or Cells, 1989 of Environment Protection Act, 1986. No imported r- pharma product is allowed to be introduced in the Indian market without adequate evaluation of clinical trial data or clinical evaluation on the Indian population. In consideration of the regulatory objective of RCGM, GEAC and DCGI, the regulatory procedure for five categories has been rationalized.