Biotechnology Regulatory Authority of India Bill, 2012

Biotechnology Regulatory Authority 

1. BRAI will regulate the research, transport, import, manufacture and use of organisms and products of modern bio-technology (genetically modified (GM) products) in the country.


2. Look at impacts on human and animal health as well as the environment.


3. The government wants to set up the BRAI in place of the Genetic Engineering Approvals Committee (GEAC). The BRAI will be the apex regulatory body with representation from several ministries, is a three-member regulator that will act as single-window clearing house for all GM commercial applications.


4. The bill takes away from state governments the power to reject a biotechnology product; it overrides the constitutional right of states on agriculture and health by making the proposed authority solely responsible for releasing and controlling GM organisms in the country.


5. The bill envisages only an advisory role for states in the form of state biotechnology regulatory advisory committee; the committee will have no decision-making powers.
6. The Bill provides for setting up of Inter- ministerial Governing Board to oversee the performance of the Authority and a National Biotechnology Advisory Council of stakeholders to provide feedback on use of organisms and products of biotechnology in society. 

CRITICAL OMISSIONS

1. Not a broad-based body representing diverse fields 
2. No participation of state governments, stakeholders (farmers & consumers groups) or public interest groups
3. Risk management neglected, No provision for liability, redressal or  recall of products
4. No clear provision for revocation of approval to prevent harm to public or environment
5. Post-marketing surveillance and monitoring absent
6. Statutory Bioethics Commission
• Genetically modified organisms
  ** Biotechnology Regulatory Authority of India

DANGEROUS PROVISIONS

1. Act to have overriding effect on other laws 
2. Jail and stiff fines for those who mislead the public about the safety of GMOs* and products
3. No disclosure of confidential commercial information but this information not defined
4. Union government can give directions to the Authority
5. Union government can amend Schedule I (list of specified organisms and products)
6. Permits delegation of authority to the chairman
7. No legal action allowed against the Union government, BRAI** and other bodies or officials functioning under this Act

Analysis : http://www.cipra.in/paper/BRAI.html