Biosafety Regulation in India: the Way Ahead

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BIOSAFETY REGULATION IN INDIA: THE WAY AHEAD

Part-I Introduction
India has placed great importance on the development of a strong scientific sector since its early days as an independent country. As a subset of science and technology, India quickly identified the potential biotechnology had for fostering national development. The Sixth Five Year Plan, which set out the developmental priorities of India for 1980 - 1985, signalled out biotechnology as a useful tool to meet the health and agriculture needs of the Indian population.Later on, in February 1986, a full fledged Department of Biotechnology was created that was independent and which could independently pilot singularly the multi faceted development in biotechnology in the country. These development raised a lot of Biosafety concerns which led to development of regulatory regime around the world. India was one of the earliest countries to establish a biosafety system and Biosafety rules were introduced even before the Convention of Biosafety was adopted at Rio De Janeiro in 1992. The Ministry of Environment & Forests had enacted Environment and Protection Act in 1986 to provide for the protection and improvement of environment and the related matters. Under this act, the Rules for Manufacture, Use/Import/ Export & Storage Of Hazardous Micro Organisms/ Genetically Engineered Organisms or Cells, 1989 were notified by MoEF through Notification No. 621 in Official Gazette of Govt. of India on December 5, 1989. India was thought to have a regulatory system which was in place to tackle any problem relating to bio safety but the failure of Bt cotton provoked a serious debate regarding the safety of Agriculture Biotechnology in the country. This was a major back to the government and clearly indicated the lack of regulations on the Biotechnology front. In a couple of years, there were a series of legislations to agnate Biosafety regulations which included mainly National Biosafety Act, 2002. There has been a constant chance in the Biosafety regime but the discussion on restructuring of Biosafety regulations never took a back seat and has been a concern even today after almost a decade. The seminar paper will essentially look into the Biosafety regulation in India, what are the lacunas in it. Part-I provides a very brief introduction to the topic. Part-II will be dealing with the framework of the Biosafety regulation in India. The Author has looked at both the national as well as international front. She has also tried to provide a structure of the entire regulatory framework in III part of the Paper. In Part-IV of the paper, the author will be elucidating the Biosafety regulation. The next part (Part-V) will assess the proposal for the structure change. Part V critiques the present structure which exists. Lastly, the author will conclude with certain recommendations. Part-II Framework of Biosafety Regulation

When assessing the Indian legal framework for biotechnology, attention must be paid both to international compromises and internal norms. It is party to many treaties which have an impact on the domestic regulation. These treaties pertain to several public international law regimes, such as international trade law, international environmental law, intellectual property law and international human rights law. The National regime has mainly evolved from the EPA, 1986. International Level

India is party to several international treaties that directly impact on biotechnology regulation and management. India is a signatory to an agreement establishing WTO, thus it is bound by its agreements and, among them two of them need to be looked into in particular: 1) the Technical Barriers to Trade Agreement

The agreement prescribes the adjustment of national regulations to international standards, something which can be of relevance in case of standards aimed at safeguarding the quality, biosafety and efficacy of biotechnological products; and 2) the TRIPS...
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