On April 22, 2013, the Biotechnology Regulatory Authority of India (BRAI) Bill-2013 was tabled in the Lok Sabha.  The  Biotechnology Regulatory Authority will be run by a small group of technocrats.  Furthermore, the Bill’s goal is to “encourage” the safe application of modern biotechnology.  The bill states that BRAI will have a Chairperson, two full-time members, and two part-time members, all of whom must be experts in life sciences and biotechnology in the environment,  general biology, agriculture , and health care. It will also establish the Biotech Advisory Council, which will provide strategic counsel to the authority on issues pertaining to modern biotechnology and its consequences in India. The governing body will be an independent and statutory entity that will oversee biotechnology product and organism research, transportation, import, and manufacturing. The projected BRAI would serve as the government’s nodal organisation for ensuring complete safety evaluations of organisms and biotech goods. It would control the studies that precede clinical trials in the health sector, while maintaining the current process for regulating clinical trials.

Let’s now look at the highlights of this Bill:

• The bill creates the Biotechnology Regulatory Authority of India (BRAI), which will control modern biotechnology organisms and goods.
• BRAI will govern biotechnology product research, transportation, import, containment, environmental discharge, production, and use.
• BRAI’s regulatory approval will be obtained after a multi-level examination process by scientific experts.
• The product developed will be certified by BRAI to be safe for its intended application. All other laws that govern the product will remain in effect.
• For civil cases, A Biotechnology Regulatory Appellate Tribunal will be set up. It will take care of the cases involving a significant question of modern biotechnology, as well as appeals from BRAI rulings and decrees.
• for giving false information to BRAI, conducting unapproved field trials, obstructing or impersonating an officer of BRAI and for contravening any other provisions of the Bill, penalties shall be provided.

Demerits of the bill:

• The regulatory authority is to be housed in this Bill by a Ministry promoting  biotechnology (Ministry of Science and Technology) – the ones who promote cannot regulate the same because there is an obvious contradiction of interest  The Department of Bio Technology, which is part of the Ministry of Science and Technology, has proposed the BRAI Bill to promote biotechnology in India. In this case, the biotechnology promoter will play a key role in forming the sector regulator and helping its operation. There is a major conflict of interest when GM crops are promoted and regulated by the same ministry. The goal of this regulatory bill is to “promote the safe use” of technology. Legislation is not required to promote a technology. If the regulation is needed, its needed only for one reason, i.e. in order to protect the health and livelihood of people and the environment from the risk of modern biotechnology. But the bill nowhere expressly mandates that.
• The Bill has ramifications for and has implications on matters governed by other independent laws, such as the Environment Protection Act of 1986, the Right to Information Act of 2005 , the Forest Rights Act of 2006, the Forest Conservation Act of 1980,the Panchayat Raj Act of 1993, , the Drugs and Cosmetics Act of 1940, the Food Safety and Standards Act of 2006 , the Nagarpalika Act of 1992, and the Biological Diversity Act of 2002, to mention a few, and retains the power of Such a broad bill necessitates more extensive debate, which has yet to occur.
• The said bill goes against the federal polity inherent in the Indian Constitution, as well as the Panchayat Raj Institutions’ powers. It takes away these organisations’ jurisdiction over agriculture, health, and natural resources, and concentrates decision-making in a small, technical group.
• A substantial question which is relevant to modern biotechnology’ falls under the Tribunal’s jurisdiction. The Bill, nonetheless, does not clarify this terminology.  Leaving a phrase ambiguous can raise uncertainty while also allowing for flexibility. End note being, it can create confusion in future due to its lack of clarity.
• One judicial member and five technical members will make up the Tribunal according to the bill.  This is in violation of a Supreme Court decision in the case of Union of India vs. R. Gandhi, Madras Bar Association that states that the number of technical members on a Tribunal bench cannot be more than the number of judicial members.
• The technical members of the Tribunal must be distinguished scientists or government officials with relevant experience. It’s uncertain whether the government official’s technical expertise can be compared to the expertise of scientists.
• The bill makes no provision for culpability for damage caused by a biotechnology product. As a result, determining culpability deriving from any negative impact of modern biotechnology will be left to the courts.

Conclusion: As per my critical analysis of the Biotechnology Regulatory Authority of India (BRAI) Bill-2013, it will be of no good for the industry if it comes in its present form. The proposal goes after citizens’ constitutional rights, such as their right to information, their right to choose, and even their right to seek judicial recourse. The state government will have a limited involvement under the bill. The right to choose safe food and to ask for it would be destroyed under the weight of international corporations, which would then take control the country’s agriculture sector. If this bill becomes a law, farmers will be left at their mercy, and we will soon see another wave of farmer suicides across the country. The legislation should be enacted to improve biosafety and democracy in the country, not the other way around.