Biotech watchdog on cards

Regulatory body to have final say on GM crop

In denying permission to Bt Brinjal, Ramesh had argued that the safety of the GM eggplant was not proven satisfactorily even though a statutory regulatory panel gave its clearance.

The new Biotech Regulatory Authority of India would stop ministers from using safety as a reason to deny permission to commercialise GM crops.

“BRAI will be the supreme authority to declare a biotechnology product safe and effective,” said M K Bhan, secretary in the Department of Biotechnology (DBT), which has created the new body.

The regulator would also make approval process more informed, smooth and less time-consuming. Having secured the Cabinet approval for the body, DBT may introduce the bill to bring it into existence in Parliament during the next budget or monsoon sessions.

Introduction of the bill last year led to intense inter-ministerial debates, following which key changes were made to the bill that was approved by the Cabinet headed by Prime Minister Manmohan Singh last week.

The five-member BRAI will take the final call on any GM product based on a technically-informed risk assessment and socio-economic analysis. Ministers will not have the power to veto its decisions.

Once a GM crop, recombinant drug or vaccine is approved, the Ministries of Agriculture and Health or the state governments can decide if they can be released in the market under specific laws like the Seeds or Drugs Act or subject the marketisation to the needs of the states. But they will no longer be able to raise the “safety” concerns.

The environmental concerns under the Environment Protection Act, would be addressed by a special environment panel, housed in BRAI. Inputs from the green panel will be fed to the BRAI members who will take a final call.

“The existing regulatory structure with genetic engineering approval committee (GEAC) and review committee on genetic modifications (RCGM) will cease to exist once BRAI is in place,” said a DBT official.

For biological materials like drugs and vaccines, BRAI will carry out the risk analysis whereas the decision on allowing human trial would be taken by a joint panel comprising members from BRAI and drugs controller general of India.