Biotechnology Regulatory Authority of India - BRAI

By : Neha Dhyani

Updated : Mar 21, 2022, 9:06

The Biotechnology Regulatory Authority of India (BRAI), 2013, is a proposed statutory and regulatory authority responsible for regulating genetically modified organisms (GMOs). The proposed authority, an outcome of the Biotechnology Regulatory Authority of India (BRAI) bill in the Lok Sabha, the Lower House of the Parliament of India on 22 April 2013, will be conducting field trials for genetically modified crops.

It will also overlook and regulate all activities about modern biotechnology products and organisms in India. It will regulate the research, transport, manufacture, and import concerning biotechnology products and organisms. It will also assist India in keeping the country’s regulatory measures in pace with the fast biotechnological advancement in terms of technology while ensuring the safety of human and animal health and the environment.

Biotechnology Regulatory Authority Of India Bill

  1. India ratified the Cartegena Protocol in January 2003, and as a result, the Biotechnology Regulatory Authority of India (BRAI) was proposed to ensure the protection of biodiversity from GMOs. The Genetic Engineering Approvals Committee is currently responsible for approving genetically engineered products. If the BRAI Bill is passed, the Environment Appraisal Panel will take over this responsibility, a sub-division of BRAI itself.
  2. As understood, a few technocrats will take all decisions of the proposed Biotechnology Regulatory Authority. And the body’s primary objective is to promote the safe usage of modern biotechnology, keeping in mind the goodness of health and the environment.
  3. Further, according to the BRAI Bill 2013, there will be an inter-ministerial governing board to supervise the performance of BRAI. It will be the highest Government agency responsible for comprehensive safety assessment of organisms and biotech products.
  4. BRAI rests the right of certification on whether the products developed are safe for the intended purpose.
  5. There will be a Biotechnology Regulatory Appellate Tribunal to civil case hearing on issues about modern biotechnology. It will also hear appeals of orders and decisions given by BRAI.

Obstacles in Biotechnology Regulatory Authority of India

As Suman Sahai calls the bill flawed, let us understand what the obstacles towards the realization of this bill are:

  1. The bill fails to define the powers and responsibilities of the new institutions it proposes.
  2. The second issue with the bill is that it does not specify what is to be included in the substantial question relating to modern biotechnology’ that the tribunal will have jurisdiction upon. This will lead to the flexibility that can cause ambiguity.
  3. The bill is said to deny the federal polity and powers of the Panchayat Raj Institutions as written in the Constitution.
  4. As per the decision of the Supreme Court, the number of technical members in the tribunal cannot exceed the number of judicial members. But the proposed tribunal will have one judicial member and five technical members.
  5. There is also confusion regarding selecting technical members as given in the bill. The technical members should be either scientists or government officials. Now the concern is whether the expertise of the two is the same?
  6. The Biotechnology Regulatory Authority of India bill also fails to specify any liability for the damages from biotechnology products.
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FAQs on Biotechnology Regulatory Authority of India

Q.1) What does the term Biotechnology mean in the Biotechnology Regulatory Authority of India?

Karl Ereky first used the term in 1919 to mean the process of producing products from raw materials with the help of living organisms.

Q.2) What is the importance of biotechnology?

Biotechnology follows cellular and biomolecular processes to develop products and technologies to improve our lives. Biological technology systems and living organisms develop different products with improved quality.

Q.3) Who currently regulates Biotechnology In India?

Genetic Engineering and Approval Committee [GEAC], which is constituted under the Ministry of Environment and Forests, is presently the leading regulatory body in the area of Biotechnology in India.

Q.4) What are the branches of Biotechnology?

Animal Biotechnology, Industrial Biotechnology, Medical Biotechnology, Environmental Biotechnology, and Plant Biotechnology.