THE BIOTECHNOLOGY REGULATORY AUTHORITY OF INDIA BILL 2013

What is Biotechnology Regulatory Authority of India:- a proposed regulatory authority to regulate the research, transport, import, manufacture and use of organisms and products of biotechnology.

Why we need Biotechnology Regulatory Authority of India:- because India has signed “US convection on biodiversity” and  “Cartagena protocol on Bio-safety ” which make regulatory authority necessary.

Current status: Currently biotechnology is regulated by “Ministry of Environment and Forests” and “Department of Biotechnology” under “Ministry of Science and Technology”.

Highlight of bill:

• set up an independent authority .
• regulate products and processes of Biotechnology and certify that the product is safe.
• Doesn’t specify for any liability, the tribunal and the court will decide the liability.
• Field trials of the modified products  will only be conducted after permission from BRAI.
• For a drug or vaccine with elements of biotechnology, the Central Drugs Standard Control Organization (CDSCO) will forward the application to BRAI to assess whether it is safe to proceed with a clinical trial.

BRAI UNITS:-

• Risk Assessment Unit (RAU): The RAU will undertake science  based safety assessments of the applications.
• Product Rulings Committee (PRC): The report of the RAU will be forwarded to the PRC and the PRC will make recommendations regarding the safety of the product or organism.
• Environmental Appraisal Panel (EAP): BRAI may refer an application to the EAP, in case of products or organisms having an environmental impact.

Opposition :-

• The states are objecting that Center is trying to interfere in state right because the Bill brings the regulation of biotechnology under the powers of the center. The Centre claims that the states still have the powers in issues like GM technology as agriculture belongs to the State list
• The bill bypasses the RTI under the garb of being “Confidential Commercial Information”.
• Conflict of Interest : this bill seen as a quick one-stop clearing house to benefits GM corporation as a committee of  just 5 scientists will be empowered to clear the patented technology for use in whole country.