RULES AND REGULATIONS

1. Convention on Biological Diversity (1992)

2. Cartagena Protocol on Biosafety

3. The Indian Environment (Protection) Act, 1986

4. Ministry of Environment and Forests Notification

Rules for the manufacture, use/import/export and storage of hazardous microorganisms/genetically engineered organisms or cells, 1989

5. Recombinant DNA safety guidelines, 1990

6. Revised guidelines for research in transgenic plants & guidelines for toxicity and allergenicity evaluation of transgenic seeds, plants and plant parts, 1998

7. Seed Policy 2002

8. Plant Quarantine (Regulation of Import into India) Order, 2003

9. The Food Safety and Standard Bill, 2005

10. Regulation for Import of GM products under Foreign Trade Policy (2006-07)

11. Proformas for approvals

(i) Information to IBSC/ RCGM for Import/ Exchange of GMOs and products thereof for research purpose.

(ii) Information to IBSC/ RCGM to carry out research for development of rDNA products

(iii) Information to IBSC/ RCGM to carry out research for development of transgenic plants

(iv) Half yearly report of the Institutional Biosafety Committee to RCGM.

(v) Medical report format

(vi) Application to GEAC for environmental approval of Clinical, Veterinary and Food Products based on hazardous microorganisms/GMO.

(vii) Application to GEAC seeking approval under rules 8,9,10 & 11 of the Notification No. GSR 1037(E) dated 05.12.1989 issued by the Ministry of Environment and Forests under The Environment Protection Act, 1986, for transgenic plants certification

12. Drugs and Cosmetics Rule (8^th Amendment), 1988

13. Guidelines for generating preclinical and clinical data for rDNA vaccines, diagnostics and other biologicals, 1999

14. Drug Policy 2002

15. Notification dated January 20, 2005 revising schedule Y rules

16. Schedule M of Drugs and Cosmetics Act

17. Report of the Task Force on Recombinant Pharma

18. Notification on the Recommendation of the Task Force on R-Pharma