Government of India
Ministry of Science & Technology
Scientific and technological breakthroughs of a transformational nature relevant to economic and social development happen only once in a while. The emergence of such technologies evokes responses according to a pattern: initial excitement, followed by strong expression of concern and then emergence of a balanced perspective. Transformational technologies in the past, such as steam engine, electricity and other sources of energy, vaccines & immunization and internet have all followed this trend. Molecular biology and biotechnologies developed through major investments in science and technology globally have a transformational potential for benefitting agriculture and health and it is time now to evolve a balanced perspective.
The members of the Scientific Advisory Committee (SAC) to the Prime Minister deliberated on the important issue of application of biotechnology for social and economic advancement of the country particularly in the area of agriculture. There are uncertainties in some segments of society that need to be objectively and fairly addressed. The members of the SAC are concerned that a science informed, evidence based approach is lacking in the current debate on biotechnologies for agriculture. There are some key aspects that merit consideration.
Do we need new technologies for agriculture? Indian agriculture productivity is seen by the less discerning to be adequate for today’s needs but what is ignored is that vast numbers of our countrymen are unable to consume the required food and nutrients because of difficult access. As our current efforts to address the issue of access bear fruit, the need for food and quality nutrients’ will grow rapidly. Land availability and quality, water, low productivity, drought and salinity, biotic stresses, post harvest losses are all serious concerns that will endanger our food and nutrition security with potentially serious additional affects as a result of climate change. Accordingly, strategies for agriculture in future must be based on higher yields, concomitant with reduction in resource inputs. This will require a judicious blend of traditional breeding and new technologies, non-transgenic & transgenic. This situation in developed countries such as in Europe; quite in contrast, as there is no dearth of food and a small proportion of people engage in agriculture.
The assessment of safety and efficacy of biotechnology products has to be evaluated through an appropriate regulatory system on a case by case basis, as for drugs and vaccines. In general, endorsement or opposition to a generic technology is scientifically not rational and safety and efficacy must be judged on product basis. The need for an appropriate regulatory mechanism in the country has been rightly emphasized in the Swaminathan Committee Report. The existing system based on RCGM and GEAC have given us large experience and its operational guidelines are generally sound and as per the best international norms such as guidelines by OECD. The effort now should be on effective implementation. Regulatory systems evolve with experience and review based redesign. Little is served by focusing on the flaws only.
The proposed Bill for establishment of a national Biotechnology Regulatory Authority of India (BRAI), 2012 is with the Parliament, it deserves to be examined on a priority basis. The key characteristics of effective regulatory system hardly need reiteration; sound scientific expertise within the organization and through independent panels, access to scientific tools for assessment of safety and efficacy and processes that ensure transparency, freedom from conflict and competence. This can only be delivered by a robust and independent system. The focus of the regulatory authority has to be on assessment of safety and efficacy. Commercialization and deployment of agriculture biotechnology products requires expertise in social and economic evaluation and post-deployment surveillance. This requires effective inputs of central and state agriculture ministries.
The experience with the deployment of Genetically Modified (GM) crops worldwide is growing at a steady pace and should be taken into consideration. GM crops of maize, soya, potato, sugar beet, canola, cotton and alfalfa and grown across the globe covering 160 million hectares by 2011. While each concern must be addressed through scientific approach, we believe the performance of GM crops released through oversight by regulators has been very positive. This view has been endorsed by major scientific bodies of the world. This is clearly true of our own experience with introduction of Bt Cotton in India wherein the benefits have been major. It is our view that biotechnology research and development should target important national needs, products should be developed under careful regulatory oversight and deployed in a way that access and affordability to entire farming community, particularly small and marginal farmers, is ensured.
There are other relevant issues that merit attention. Some of the opposition to GM crops in the country results from fear of domination by multinational companies. One way to address this concern is to invigorate and further strengthen the relevant scientific capacities of our institutions in public sector, universities and Indian companies. The current debate, unfortunately, is demoralizing and isolating our Scientists in the sector whose skills have been built with painstaking effort and large investment. The policy confusion will also keep the brightest away from this field of research. Our Scientists are fully aware of the social realities in this country and have widely endorsed the judicious adoption of traditional breeding with biotechnologies, non-transgenic and transgenic, as appropriate. There is concern about the costs at which seed is available to our farmers, particularly the poor farmers. This requires an appropriate public policy and action. The industry must shoulder responsibility by ensuring this through constructive dialogue with the government. Market mechanisms alone will not be sufficient.
The precautionary approach is inherently sound but it must be applied through a science based safety assessment and social and economic analysis for deployment. We make the following recommendation for kind consideration:-
1) The current regulatory system for recombinant products administered under Rules (1989) of EPA Act, 1986 should be reformed till BRAI is in place.
(i) RCGM and GEAC should be the sole authority for biosafety and bio-efficacy assessment of all recombinant products. Decision on commercial use of biotechnology produced crops should be taken by the Agriculture Ministries/Department of Central and State Governments as per existing policies and regulations on crops. For medical products Central Drugs Standard Control Organization (CDSCO) of Ministry of Health and Family Welfare, Government of India would approve commercialization as of now.
(ii) High Level dialogue with State governments to streamline clearances for conduct of multi-location “Confined field trials” – a scientific pre-requite in all countries for meaningful decision making on approvals or otherwise.
(iii) A Biotechnology Regulatory Secretariat with high level of scientific and technical trained manpower should be established to support RCGM and GEAC.
(iv) GEAC and RCGM should have full time Chairpersons. The Chairman of GEAC, may be of Special Secretary Status for 3 year period and RCGM one level lower. Chairman of RCGM be the Co-Chair in GEAC and not the expert nominee of Department of Biotechnology. For greater synergy at least three members should be common between RCGM and GEAC.
(v) The public needs to be informed of every decision.
2) The Bill pending with Parliament, i.e. BRAI 2012, should be debated with open mind. It would be appropriate if administrative organization could be Cabinet Secretariat because of the involvement of multiple ministries. The Bill when examined by appropriate parliament committee would be opened up for wider debate and discussions for shaping the draft legislation into a model regulatory framework.
3) The capacity for regulatory testing of new technologies in agriculture in public sector laboratories should be strengthened, supplemented with a system of notification and accreditation. This can be initiated even while the BRAI becomes a reality.
4) Research and infrastructure of state agriculture universities and colleges be strengthened for addressing the locations- specific needs of the states and regions and generate expertise.
5) Priority should be given to strengthen State Government departments and laboratories dealing with agriculture inputs, including GM or non GM seeds, extension and education of farmers through major programmes and investments for capacity building tailor made to the needs of the region.