Your client wants to set up a Bio-technology unit in Bengaluru. Describe the details of specific laws applicable to a Bio-technology industry.
CS Professional · Secretarial Audit, Compliance Management and Due Diligence · PYQS · June 2022
Your client wants to set up a Bio-technology unit in Bengaluru. Describe the details of specific laws applicable to a Bio-technology industry.
Answer & Explanation:
The Biotechnology industry in India is divided into the segments namely- Biopharmaceuticals, Bio-services, Bioagriculture, Bio-Industrials and Bio-IT. India is one of the top biotech destinations in the world. India is working to boost the biotechnology sector under the flagship programmes such as 'Make in India' and 'Startup India'. Specific Laws applicable to the Biotechnology sector includes: Rules for the manufacture, Use/Import/Export and storage of hazardous micro organisms/ Genetically engineered organisms or cell, 1989 Revised recombinant DNA safety guidelines Guidelines for research in transgenic plants and guidelines for toxity and allergencity evaluation of transgenic seeds, plants and plant parts, 1998 The plants, Fruits and Seeds (Regulation of import in India) Order 1989 issued under the destructive Insects and Pests Act, 1914 Guidelines for generating Preclinical and Clinical data for DNA Therapeutics,1999 National Seed policy 2002 Seeds Act, 1966 EXIM Policy Pertaining to Biotechnology Environment Protection Act, 1986 pertaining to Biotechnology Foreign Exchange Management Act, 1999 pertaining to Biotechnology Protection of Plant Varieties and Farmers' Rights Act, 2001.
Topics: Industry Specific Laws
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