Introduction of the Biotechnology Regulatory Authority of India (BRAI) Bill has brought cheers to the agri-biotechnology industry that was facing a setback following states’ refusal to conduct GM field trials. V Ram Kaundinya, chairperson of the country’s largest agri-biotech association ABLE-AG, shares his views with Jyotika Sood. Excerpts from the interview:
Does BRAI cater only to industry?
The BRAI Bill promotes safe use of modern biotechnology by enhancing efficiency of regulatory procedures. BRAI will regulate research, import, manufacture and use of organisms and products of biotechnology. Therefore, the Bill not only helps the private industry but also supports the public sector.
Do you see conflict of interest in the Bill being introduced by the science ministry?
Conflict of interest needs to be looked into if the member or agency dealing with a case is deriving any undue advantage. Biotechnology applications are already part of activities in several ministries.
Does it really matter under which ministry the BRAI works?
No. However, it should not land with a ministry which does not understand the high-tech science.
Will you object if the mandate is given to the environment ministry?
That is the prerogative of the government. Number of activities of the environment ministry are being undertaken by civil societies and they have good access to the functions of the ministry. If the BRAI Bill is with the environment ministry, then the groups could exert their influence to curtail the Bill.
With states opposing GM trials, do you think BRAI will help industry?
Biotech research is suffering irrespective of activities being undertaken by the public or private scientists. If the Bill is implemented, issue of states not allowing GM trials could be addressed and BRAI would provide technical and financial support to states.
What about issues like no risk assessment and no mechanism for transparency under BRAI?
In present environment, information is a vital commodity. In the business world “confidential commercial information” is essential for survival. If one looks at the pharma industry before the Indian Patent Act was amended in 2005 it flourished based on the information available in patent documents made public by the statute of country. If the information was not disclosed, do you think the industry would have produced similar products by reverse engineering at the cost of product inventor?
Will BRAI make GM entry easy?
It would be premature to say so; functioning of BRAI would only provide inferences.
GM organisms (GMOs) and their risk assessment are a concern. How will industry dispel it if the BRAI Bill is implemented?
Clause-41 of the Bill states it would designate institutions to generate required information, which means BRAI would accredit the institutions. Regulatory authorities worldwide accept the data generated by the accredited institutions, then why should it be different in India?
BRAI would be undertaking outreach activities and, hopefully, would provide a platform to the scientific community to dispel misinformation on the risk assessment of biotech products.
Like farmers and MPs, does ABLE-AG also have any objections to BRAI?
We have objections but have not finalised them yet. Once finalised, we would submit them to the government.
The Biotechnology Regulatory Authority of India Bill, 2013
The Biotechnology Regulatory Authority of India Bill, 2011
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