Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms Genetically Engineered Organisms or Cells (Amendment), 2006

MINISTRY OF ENVIRONMENT AND FORESTS NOTIF1CATION New Delhi, the 20th September, 2006 G.S.R.6l6(E).- Whereas the Ministry of Environment and Forests has notified the rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms / Genetically Engineered Organisms or Cells, Rules 1989 hereina~er referred to as Rules vide No. GSR.1037 (E) dated 5th December 1989, And whereas rule 2.0 of the rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms / Genetically Engineered Organisms or Cells, Rules 1989 empowers the Ministry of Environment and Forests to exempt an occupier handling a particular microorganism/ genetically engineered - organism from the application of the provisions of Rules 7 to11 (both inclusive). Now, therefore, in pursuance of rule 20 of the rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms / Genetically Engineered Organisms or Cells, Rules 1989, the Central Government hereby considers it necessary that the manufacturer and/ or importer of recombinant pharmaceuticals falling in the following categories niay be exempted from the provisions of rules 7 to 10 (both inclusive) of the above said Rules with effect from the date of publication of this notification in the official gazette. (a) Indigenous product development, manufacture and marketing of pharmaceutical products derived from organisms falling under Risk Group I and Group II as specified in the Recombinant DNA Safety Guidelines, 1990. (b) Import and marketing of products derived from Living Modified Organisms (LMOs) as Drugs and Pharmaceuticals in bulk and/or finished formulations where the end product being imported is not a Living Modified Organisms. [F. No. 12/7/2004-CSI DESH DEEPAKVER.MA, Jt. Secy. Note:- the principal rules were published in the Gazette of India vide num~r GSR 1037 (E) dated s.f2.1989, which came into force vide not1f1cat~1on 50 677 (E) DATED 13 September 1993 and amended vide notification GSR 493 (E) Dated 14 July 2005.