National Biotechnology Regulatory Authority

12.8  With regard to the institutional arrangements, the Task Force is of the view that GEAC should consist of members with the requisite expertise and should be headed by an outstanding biosafety and biotechnology experts. The structure of the Atomic Energy Regulatory Board could be suitably adapted for establishing an autonomous statutory National Biotechnology Regulatory Authority (NBRA) in the place of the existing GEAC. With rapid growth in R & D efforts in biotechnology, a statutory and autonomous National Biotechnology Regulatory Authority will soon become necessary. The NBRA should have two wings – one for agricultural and food biotechnology and the other for medical and pharmaceutical biotechnology. NBRA is essential for generating the necessary public, political, professional and commercial confidence in the science based regulatory mechanism in place in the country. The chairperson of NBRA could provide guidance and oversight to both the agricultural and medical wings. The members could be different in the case of the two wings. Having a common NBRA with two distinct wings will be useful to consider bio- and food safety issues in an integrated manner, in the case of products like crop-based oral vaccines and neutraceuticals.

12.9  Until an autonomous statutory NBRA comes into existence, GEAC may have two wings/committees to deal with agricultural applications and pharmaceutical applications separately and exclusively.

12.10 Evaluation of the field performance of GM crops should be transparent. Unfavourable results should also be highlighted. Evaluation mechanisms should enjoy functional independence and high scientific and public credibility. Mandatory maintenance of detailed record notebooks should be enforced which could be examined as and when needed.

12.11 The Task Force feels that in the process of evaluation and commercial release of GM crops/ products, the following should also be kept in view. 

• The Set of bio-safety data necessary for seeking approval should be clearly established.

• As far as possible, data and protocols pertaining to bio-safety testing from International sources should be harmonized.

• Additional accredited laboratories should be identified/created for evaluating claims and verifying biosafety standards, the existing ones should be further strengthened

• Agronomic evaluation in terms of traits to be considered, years of testing and agencies responsible for testing need to be clearly spelt out for each crop. This should be a priority task of the proposed ICAR All India Coordinated Project responsible for the evaluation of GM crops and varieties.

• Provisions of PPV&FR Act and Seeds Act for protecting IPRs should become better known.

• Periodicity of meetings of Committees concerned with various approvals should be regular and conducted on a well-scheduled annual calendar basis. A crop-season should not be lost due to avoidable delays in the decision making process.

• Bio-safety evaluation procedure should be suitably adapted in cases where two or more deregulated transgenic events are pyramided through conventional breeding. However, gene expression concerned with combined effects of the two genes along with VCU should be evaluated.

• Various evaluation reports and approval, once finalized, should be made public in a transparent manner and placed on a designated website.

• A clear policy/guidelines on feeding of GM foods to livestock and use of livestock products from animals fed with GM food should be developed and enforced.

• Concerted efforts should be made to educate the public about transgenic technology. Civil Society organizations, Womens’ Associations, Home Science Colleges, KVKs and other agencies/stakeholders should be involved in this task.

• Rules for procurement of chemicals/equipments for biotechnology research in Govt. research Institutes should be simplified so that the pace of research can be accelerated.