India is among the top 12 destinations for biotechnology worldwide.
Department of Biotechnology [DBT] constituted under the Ministry of Science and Technology is the nodal agency for policy, promotion of R&D, international cooperation and manufacturing activities. Together with DBT, Genetic Engineering and Approval Committee [GEAC] constituted under Ministry of Environment and Forests [MoEF] is the leading regulatory body in the area of Biotechnology in India.
The Biotechnology industry in India is governed by the following enactments depending upon their relevance/applicability on case to case basis:
1. Environment Protection Act, 1986
2. EXIM Policy
3. Foreign Exchange Management Act, 1999
4. Laws pertaining to Intellectual Property Rights
5. Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/Genetically Engineered Organisms or Cells, 1989 notified by Ministry of Environment & Forests on December 5, 1989 under Environment and Protection Act, 1986.
6. Revised Recombinant DNA Safety Guidelines
7. Guidelines for Research in Transgenic Plants & Guidelines for Toxity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts, 1998
8. National Seed Policy, 2002
9. Seeds Act, 1966
10. The Plants, Fruits and Seeds [Regulation of import in India] Order 1989 issued under the Destructive Insects and Pests Act, 1914.
11. Guidelines for Generating Preclinical and Clinical Data for rDNA Therapeutics, 1999
12. Drugs & Cosmetic Act 1940 along with Drugs and Cosmetic Rules
13. Drug Policy, 2002
14. Biological Diversity Act
Law relating to biotechnology is a growing field of law, which in precision puts together different disciplines of law such as IPR Law, Trade Law, Environmental Law, Biodiversity Law, Human Rights Law
Our team is closely working with several bio technology leaders and assisting them in their Joint Venture Agreements, Advance Transfer Pricing, Dispute Resolution, Intellectual property and other allied laws.
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