“The Bill provides for setting up of inter-ministerial governing board to oversee the performance of the authority—National Biotechnology Advisory Council…” said the outgoing minister of earth sciences Prithviraj Chavan. The previous draft of the Bill seeking to introduce the regulator under DBT was openly criticised by the environment minister Jairam Ramesh who felt that such a regulator should either be formed under the Cabinet secretariat or a department separate from the biotechnology to avoid issues of conflict of interest.
The regulatory body, according to the latest draft of Bill, would comprise of a chairperson, two full time and two part time members, each with an expertise in life sciences and biotechnology application in agriculture, healthcare, environment and biology.
BRAI is proposed to be an autonomous and statutory agency to regulate the research, import, manufacture in biotechnology products has been prepared. It will only deal with the safety and efficacy aspects of biotech products, leaving the controversial commercialisation aspect outside its scope, according to the latest version of the BRAI Bill, 2010. The plan to constitute a national biotechnology regulator has run into rough weather since many years. The earlier draft didn’t find favour with the ministry of health, which raised obejections that there is serious overlap between functions of the proposed Central Drug Regulatory Authority and the biotech regulator.
Presently, products that involve genetic engineering are cleared by Review Committee on Genetic Modification (RCGM) in the DBT and the environment ministry through a panel of experts, the genetic engineering approval committee (GEAC).