Biosafety Regulation in India: the Way Ahead
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
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
Bibliography: 1 Carl E. Pray and Prajakta Bengali, “The cost of biosafety regulations: The Indian experience” Quarterly Journal of International Agriculture 44 (2005), No. 3: 267-289. 8 Department of Biotechnology, Biotechnology – A vision (Ten Year Perspective), 2001, http://dbtindia.nic.in/uniquepage.asp?id_pk=102 Department of Biotechnology, Annual Report 2008-2009, 2010. 12 Dhar, Biswajit.. Globalisation and the International Governance of Modern Biotechnology Regulating biotechnology in India, p. 20. 2003. Available at: http://www.ris.org.in/fost_9c.html 13 Ghosh, P 14 Ghosh, P. K. (2000) Genetically Modified Crops in India with Special Reference to Cotton Silver Jubilee Lecture Series, Delivered June 23, 2000. Indian Society for Cotton Improvement (Mumbai: Central Institute for Research on Cotton Technology). 22 R. Prasad, ‘GM crops’ biosafety testing procedure questioned’, The Hindu, 25 June 2008 23 See "Failure of Bt Cotton in India" Press Release Research Foundation for Science, Technology and Ecology (RFSTE) September 26, 2002 [ 4 ]. http://moef.nic.in/divisions/cs/GEAC.htm (Last accessed: 2nd August, 2012) [ 13 ] [ 19 ]. Revised Guidelines for Research in Transgenic Plants (New Delhi: Department of Biotechnology and Government of India, 1998) [ 24 ] [ 32 ]. Suman Sahai, GMO Regulations in India and their Weakness, available at http://www.genecampaign.org/Publication/Article/gmo-reg-india-weaknessp1=ID1.htm (last visited on 10th September, 2012). [ 35 ]. Namely- Prevention of Food Adulteration Act, 1954, the Seed Act, 1966, the Biosecurity Regulations, the National Biodiversity Act, 2002 and the Protection of Plant Varieties and Farmers’ Rights Act, 2001. [ 21 ]. http://www.istockanalyst.com/article/viewarticle/articleid/2761971 (Last accessed on 25th August, 2012) [ 41 ] [ 40 ]. http://urguide007.blogspot.in/2009/12/national-biotechnology-regulatory-bill.html (Last accessed: 27th September, 2012) [ 43 ] [ 6 ]. C. Correa, J. Sarnoff, Analysis of options for implementing disclosure of origin requirements in intellectual property applications, Geneva: UNCTAD, 2006, UNCTAD/DITC/TED/2004/14. [ 3 ]. Hereinafter referred to as EPA, 1986.