The authority will restrict itself only to “scientific risk assessment” of biotech products whereas all decisions related to commercialisation of the product will be left to the departments and state governments concerned.
The new formula, according to the officials, may help in breaking the ice as Biotechnology Regulatory Authority of India (BRAI) bill faced stiff opposition from prominent members of the Parliament including Basudev Acharia (CPM), Jyoti Mirdha (Cong), C P Thakur (BJP) and Raghuvansh Prasad Singh (RJD).
Non-governmental organisations too are up in the arms arguing that the bill was drafted in an opaque manner without any deliberations with the states and if passed, it would open the floodgate for genetically modified crops.
“The authority could be transferred to the Cabinet Secretariat or Agriculture Ministry. We have no problems as long as the principle of autonomy is maintained,” said M K Bhan, secretary in the department of biotechnology, which drafted the bill.
Bhan said if the Parliament wants, the DBT secretary could be kept outside the 17-member inter-ministerial panel which will govern the authority. As per the present structure, the panel is headed by the secretary in the department of science and technology and 16 other secretaries from various ministries and departments.
DST secretary was chosen to head the BRAI governing panel as he has no conflict of interest, but those arrangement could be changed depending on the wish of the Parliament, he said.
The critics inside the Parliament wanted the bill to be sent to a select panel for scrutiny rather than to the department-related Parliamentary Standing Committee.
“Once the bill comes in front of any House panel, we would suggest to them to put BRAI under some other administrative ministry like Cabinet Secretariat or Agriculture, and to keep the DBT secretary out of it. We don't want to be a part of the regulation,” Bhan said, adding that the department had received responses from 26 states.
With the current rate of growing at 20 per cent, Indian biotechnology sector that stands at $ 4 billion will become $ 20 billion by 2020. And regulation is urgently required to keep an eye on the quality and safety of these products, which have the potential to bring revolutionary changes in healthcare and agriculture.
A special cell within BRAI, headed by an environment ministry official, will look after the environmental concerns while labeling issues will be dealt with by the Food Safety and Standards Authority of India. The authority will separate the commercialisation process from risk assessment and will not erode the right of any state government and other ministries in approving or rejecting a biotech product, he said. The authority will make all safety and risk-assessment data public, he added.