Highlights of the Bill

• The Bill sets up an independent authority, the Biotechnology Regulatory Authority of India (BRAI), to regulate organisms and products of modern biotechnology.

• BRAI will regulate the research, transport, import, containment, environmental release, manufacture, and use of biotechnology products.

• Regulatory approval by BRAI will be granted through a multi-level process of assessment undertaken by scientific experts. 

• BRAI will certify that the product developed is safe for its intended use.  All other laws governing the product will continue to apply. 

• A Biotechnology Regulatory Appellate Tribunal will hear civil cases that involve a substantial question relating to modern biotechnology and hear appeals on the decisions and orders of BRAI.

• Penalties are specified for providing false information to BRAI, conducting unapproved field trials, obstructing or impersonating an officer of BRAI and for contravening any other provisions of the Bill. 

Key Issues and Analysis

• The Tribunal has jurisdiction over a ‘substantial question relating to modern biotechnology’. However, the Bill does not define this term.  Leaving a term undefined could allow for flexibility but could also increase ambiguity.

• The Tribunal will consist of one judicial member and five technical members.  This is not in conformity with a Supreme Court decision that the number of technical members on a bench of a Tribunal cannot exceed the number of judicial members.

• The Tribunal’s technical members shall be eminent scientists or government officials with experience in the field.  It is unclear whether the technical expertise of the latter can be equated with the former.

• The Bill does not specify any liability for damage caused by a product of biotechnology.  Therefore, it will remain open to the courts to determine liability arising out of any adverse impact of modern biotechnology.

• Various committees have recommended that an autonomous statutory regulator having members with expertise in biotechnology be set up.

Read the complete analysis here