The government admits that the regulatory framework is not in consonance with biosafety requirements and the way that biotechnology is being adopted in India, yet , policies andregulatory structures have not changed.
There is no national policy on biotechnology in India to guide the adoption of genetically engineered products. Research and product development is proceeding rapidly in both agriculture and pharmaceuticals in the absence of a guiding policy document. Despite demands from several official and non-official quarters, a national policy for biotechnology has yet to be developed. The legislative framework on agro-biotechnol-ogy is provided under the Environment (Protection) Act. The Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/Genetically Modified Organisms or Cells formulated under the Environment (Protection) Act provides for a multi-tiered regulatory framework.
The procedures under the Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Micro Organisms/Genetically Modified Organisms or Cells, are lengthy and inadequate regarding biosafety. The govern-ment admits that the regulatory framework is not in consonance with biosafety requirements and the way that biotechnology is being adopted, yet, policies and regula-tory structures have not changed.
Bowing to public demand for better and more trans-parent governance, the government finally constituted two task forces on biotechnology, one to make recom-mendations in agriculture, chaired by Dr MS Swaminathan; the other to make recommendations for streamlining the regulatory framework for recombinant pharma, chaired by Dr RA Mashelkar. The mandate was to formulate a long-term policy on applications of biotechnology in agriculture and pharmaceuticals, and suggest modifications in existing administrative and procedural arrangements. Both task forces have found the regulatory system to be cumbersome, ambiguous and inadequate to deal with the challenges of transgenic technology in agriculture as well as pharmaceuticals. Their recommendations have not yet been acted upon.
The lack of transparency in the execution of agbiotechnology has frustrated civil society organizations for a number of years. The government does not provide any information on transgenic research, field trials or biosafety, despite persistent enquiries. There is neither interface with the public nor any consultations with it. Only after the passage of the Right to Information ( RTI) Act, has it become possible at least for some groups to try to access information. Most often, however relevant information is not provided or it is denied outright under the clause of ‘confidential business information’. Organisations like Gene Campaign and Greenpeace are in the forefront of trying to loosen up the provisions of the RTI Act by contesting and challenging the government’s responses. Progress is slow so far An Expert Committee was constituted in 2004 to frame a National Policy on Biotechnology. The constitution of this Committee and the process it adopted has been widely criticised as unrepresentative and non-trans-parent.
The foremost critic has been this writer (a member of the Expert Committee) who has spoken out against the absence of any consultative process and the presentation of a draft report of which the authorship is unknown. No further consultation has taken place on the draft National Biotechnology Policy, nor is the further course of action known with regard to this document.
The government has not yet implemented a policy for segregation, traceability and labelling of GE crops and foods, although large-scale field trials for brinjal, rice and okra are being conducted as a prelude to commercial cultivation. A number of food imports have been allowed under open
license and several processed foods are being imported, particularly from the US and SE Asia, which could contain GE ingredients. There is no mechanism to regulate imports nor is there a policy for labeling these products. Traders have no idea about GE crops and foods, what labelling is and how or why it should be done. There is very poor aware-ness about the nature of genetic engineering and GE crops and foods across, so labelling is unlikely to be meaningful or an instrument of choice for farmers and consumers.
India has followed the US model of regulation but lacks the scientific experience and stringency of the US system where biosafety is conducted under a voluntary, not mandatory regime. As a member of the US led ABSP I and II programmes (Agriculture Biotechnology Support Programme), India’s agenda and policy is heavily influenced by the US with respect to key concepts like substantial equivalence, precautionary principle, science based evidence vs socio economic impacts, centres of origin, liability and redressal regimes, etc. Even the initial policy on mandatory labelling of transgenic products sometimes shows signs of flagging.
Civil society groups like Gene Campaign have been pressing for a Europe style system based on the precautionary principle and strong public participation in decision making, with little effect so far. The government is even less likely to respond to such suggestions now given that it is strengthening its partnership in this field with the US. Recently (in March 2006), along with the agreement on nuclear technology, India has concluded an agreement on agriculture with the US called the ‘Indo-US Knowledge Initiative in Agricultural Research and Education’ to promote the so-called “Second Green Revolution” with its focus on developing transgenic technologies and products in agriculture. This agreement was concluded in great secrecy and without consultation with even key actors like the National Academy of Agricultural Sciences or the scientific cadre of the Indian Council of Agricultural Research. Political involvement in decision-making in agbiotechnology is practically non-existent. Bureaucrats and technocrats run the programmes arbitrarily, handing out grants and approving projects with no visible peer review process.
Against this, a successful campaign by agbiotech promoters has succeeded in associating the Gene Revolution with the Green Revolution, projecting it as an improved version of the same thing. This results in the political leadership viewing agbiotechnology as favourably as it does the Green Revolution which is perceived very positively for its contribution to end food imports and making India food sufficient. There is little understanding of the critical difference between the two, the former was a public technology, the latter is an entirely private technology, with complex and excluding IPR regimes.
Research on transgenic technology in India is continuing in both private and public sectors. Since there is no biotechnology policy, nor any process for setting research goals, there seems to be little coherence in the research
objectives. For instance, the Cry9c gene known to elicit allergic reactions and the reason why Starlink corn was banned for human use in the US, is allowed for use in research programmes. Approximately 40 per cent of research projects in the public and private sector are based on the Bt gene.
This will result in the presence of Bt containing crops in all sea-sons and it is likely that pest resistance will develop much faster than if a more judicious and restricted use were made of the Bt gene. All Bt cotton in India is being produced by the private sector and all as hybrids so that the farmer cannot save seed. India is the only Bt cotton cultivating country where it is being produced as hybrids; everywhere else, it is produced as true breeding varieties.