Monday, 24 September 2012

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. 

  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
  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


  1. How question 1(d) of paper 2 [GS-2012] get related to this concept ?

  2. Hi Vibin,
    Thankyou for the question and am sorry for the delay in responding.
    Just to recap the question "...scientists predict that plant genomics would play a critical role in keeping out hunger and preserving the environment. Explain."

    I think this question proposes that through plant genomics, the yield as well as the nutrition quality of crops can be increased. This can help in stalling the need for bringing more land under cultivation. Also, plant genomics can help makes crop resilient to pests thus avoiding the use of external pesticides and fertilizers which may have negative side-effects on the environment.

    This post provides one point on how there is a need to supervise plant genomics to assist its positive outcomes and resist its negative ones. Mentioning this angle of plant genomics could present a more wholesome picture of the debate on GMOs.

    Also, it mentions other stakeholders in the process like governments at various levels, farmers, consumers etc. So, it isn't just the scientists whose opinion matters, but all agencies who need to be taken into confidence for plant genomics to achieve its potential.

    This is how I think this post could have assisted in the answer. I would like to hear your thoughts on this.