The Biotechnology Regulatory Authority of India Bill, 2013

The Biotechnology Regulatory Authority of India Bill, 2013 was introduced in the Lok Sabha on April 23, 2013 by the Minister for Science and Technology, Mr. S. Jaipal Reddy.  The Bill aims to promote the safe use of modern biotechnology by enhancing the effectiveness and efficiency of regulatory procedures. The salient features of this bill is being provided hereinbelow:

(i)    Establishment of Biotechnology Regulatory Authority: The Bill establishes the Biotechnology Regulatory Authority of India (Authority).  The Authority will consist of a chairperson, two full time members, and two part time members.

(ii)   Regulation of Research: The Authority shall regulate the research, transport, import, containment, environmental release, manufacture and use of organisms and products of modern biotechnology.  The Authority has the power to call for information, conduct an inquiry and issue directions for the safety of products or processes of modern biotechnology.

(iii)   Field Trials only by permission of Authority: Field trials for certain organisms or products cannot be conducted unless the Authority permits them as aiding the development of modern biotechnology such as genetically engineered plants, animals used in food or any animal clones that can be applied in agriculture, fisheries or food products.  The Bill will not apply to the clinical trials of drugs, under the Drugs and Cosmetics Act, 1940, and food or food additives or any material under the Food Safety and Standards Act, 2006.

(iv)   Disclosure of confidential commercial in public interest: The Authority will not disclose confidential commercial information made available in an application to the Authority.  However, the Authority may disclose it in public interest or if this disclosure will not harm any person.

(v)   Divisions under the Authority: Regulatory divisions of the Authority have been created for the implementation of safety assessment procedures and processes.  The divisions are: (i) agriculture, forest and fisheries, (ii) human health and veterinary products, and (iii) industrial and environmental applications.

(vi)   Establishment of Risk Assessment Unit and Panels: A Risk Assessment Unit will appraise applications for proposed research, transport or import of an organism or product, before final approval is granted.  The Product Rulings Committee will make recommendations to the Authority for the manufacture or use of organisms or products. The Environmental Appraisal Panel will make recommendations on environmental safety of organisms and products.

(vii)   Other bodies: An Inter-Ministerial Governance Board has been established to promote inter-ministerial or departmental co-operation for the effective discharge of the functions of the Authority. A Biotechnology Advisory Council will render strategic advice to the Authority regarding developments in modern biotechnology and their implications in India.

(viii)   Establishment of State level body: A State Biotechnology Regulatory Advisory Committee will act as a nodal agency between the state government and the Authority with regard to the regulation of modern biotechnology.

(ix)   Appellate Tribunal: A Biotechnology Regulatory Appellate Tribunal will hear appeals against the decisions, orders or directions of the Authority.  The Tribunal will consist of a full-time chairperson, who has been a judge of the Supreme Court of India or a Chief Justice of a High Court, and five part time expert members.

(x)   Penal Provisions: The Bill imposes a penalty for providing false information (imprisonment for three months and fine extending to Rs five lakh) and conducting an unapproved field trial (imprisonment for six months to one year and a fine extending to Rs two lakh).

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