India is among the first few countries in the developing world to have recognized the importance of biotechnology as a tool for advancing growth in the agriculture and health sectors. Biotechnology has now emerged as a dominant sector in India. Total investments in the sector crossed USD 580 million during 2006-2007. Biotechnology encompasses many fields from bio-pharma to bio-agriculture. A well defined globally harmonized regulatory framework through stringent Patent law, Good Laboratory Practices, Good Manufacturing & Clinical Practices and a skilled pool of more than 15,000 scientists, 500,000 graduates, 12,000 doctorates in chemistry and 115,000 postgraduates in sciences makes India a favoured destination for collaborative R&D, bioinformatics, contract research, manufacturing and clinical research. Improving human subject protection and increasing international acceptability of Indian data further strengthen India’s position as a preferred clinical outsourcing destination.
Department of Biotechnology, Ministry of Science and Technology, Government of India is the nodal department to administer the subject. FDI policy does not classify biotechnology as a specific industry. FDI up to 100% is allowed, subject to certain conditions, under the automatic route in pharmaceutical and drug industries. However, in case of industries involved in recombinant DNA technology and specific cell/tissue formulations, FIPB approval is required. The Environment Protection Act, 1986 is the basic sectoral statute in the biotechnology sector.
CLG’s regulatory practice covers biotechnology also. CLG’s interdisciplinary Biotechnology team comprises of lawyers and technical professionals having considerable experience in biotechnology. A significant part of the CLG’s Biotechnology law practice is devoted to counseling clients regarding statutory and regulatory requirements. CLG has assisted its clients in preparing technical research papers, obtaining necessary regulatory licenses and statutory approvals.
CLG has also rendered consultancy services in the form of legal opinion on issues confronting the Biotechnology sector.
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