Biotechnology Regulatory Authority Bill | Science & Technology for UPSC CSE PDF Download

The Biotechnology Regulatory Authority Act, 2024

Ministry: Science and Technology

• Biotechnology Regulatory Authority of India Bill introduced on 22 April 2013
• Referred to Standing Committee on 17 May 2013
• Standing Committee report extended to 3 June 2014
• Enacted as Biotechnology Regulatory Authority Act on 15 March 2024

The Biotechnology Regulatory Authority Act, 2024, superseding the Biotechnology Regulatory Authority of India Bill, 2023, and replacing the Biotechnology Regulatory Authority of India Act, 2015, establishes a comprehensive framework for regulating modern biotechnology in India. It addresses the benefits, risks, and ethical dimensions of biotechnology, emphasizing public health, safety, and environmental protection while fostering innovation under initiatives like Atmanirbhar Bharat.

The Act introduces the Biotechnology Regulatory Authority (BRA) as a single-window authority, integrating functions of the Genetic Engineering Appraisal Committee (GEAC). The BRA regulates a broad scope of biotechnologies, including genetically modified organisms (GMOs), CRISPR gene-edited crops, synthetic biology, and mRNA vaccines, reflecting advancements in agriculture, healthcare, and sustainability.

Key Issues and Analysis

• The Act defines modern biotechnology comprehensively, addressing previous ambiguities and aligning with global standards.
• The BRA Tribunal adheres to Supreme Court guidelines, ensuring judicial members equal or outnumber technical members, enhancing legal oversight.
• Technical members include distinguished scientists and experts, with government officials required to meet stringent expertise criteria.
• The Act specifies liability provisions for damages from biotechnology products, ensuring accountability and recourse through courts.
• The BRA is an independent regulatory body with experts in biotechnology, addressing recommendations from various committees.

U.S. Influence and the Biotechnology Regulatory Authority Act, 2024

The Biotechnology Regulatory Authority Act, 2024, has sparked discussions on its implications for Indian agriculture and the role of multinational corporations, particularly from the U.S. While the Act strengthens India’s strategic autonomy, concerns about external influence persist.

Key Points on U.S. Influence in Indian Agriculture:

1. U.S.-India Knowledge Initiative on Agricultural Education and Research (KIA):

   • The 2005 KIA agreement aimed to enhance agricultural collaboration, raising concerns about U.S. influence on India’s biotech policies.
   • Critics argued it could increase multinational corporations’ control over India’s agriculture, though the 2024 Act includes safeguards for strategic autonomy.

2. Establishment of the Biotechnology Regulatory Authority (BRA):

   • The BRA provides a single-window platform for biotech risk assessments, including agriculture, health, and industry applications.
   • While critics feared corporate dominance, the Act’s public consultation and ethical oversight mechanisms mitigate these concerns.

3. Stakeholder Concerns and Act’s Response:

   • Critics like Pushpa M. Bhargava raised ethical and environmental concerns, which the Act addresses through the Independent Ethics Committee (IEC) and public hearings.
   • Farmers’ unions and consumer groups’ apprehensions are mitigated by the Act’s decentralized structure, including state-level committees and farmer representation.

The Act balances innovation with biosafety, ensuring India’s biotech governance aligns with global standards while safeguarding agricultural sovereignty.

Biosafety Protection under the 2024 Act

The Biotechnology Regulatory Authority Act, 2024, establishes a robust framework for biosafety, addressing concerns about genetically modified organisms (GMOs) and emerging biotechnologies. The Act integrates the functions of the Genetic Engineering Appraisal Committee (GEAC) into the BRA, ensuring a science-based, transparent regulatory process.

Key biosafety components include:

1. Precautionary Principle: Mandates caution in approving biotech products to prevent potential risks.

2. Conditional Use of Biotech Products: Allows use only when alternatives are unavailable and long-term safety is proven.

3. Distinct Research Phases: Separates contained research from intentional release for tailored oversight.

4. Conflict of Interest Elimination: Ensures unbiased regulation through strict disclosure and recusal norms.

5. Transparency and Public Involvement: Mandates public hearings and independent reviews, enhancing accountability.

6. Rigorous Risk Assessment:

   • Requires developers to submit comprehensive safety studies.
   • Ensures independent evaluation of data.
   • Establishes facilities for third-party testing.

7. Robust Risk Management: Implements monitoring, periodic reviews, and revocation mechanisms.

8. Liability Provisions: Defines penalties and remedies for developers and regulators in case of adverse effects.

9. Labelling and Traceability: Enforces labelling for consumer choice and traceability for imports.

10. Accessible Oversight and Appeal Processes: Provides affordable mechanisms for public grievances and appeals.

11. Respect for Federal Structure: Empowers states to establish local regulatory systems, upholding constitutional authority over resources.

The Biotechnology Regulatory Authority Act, 2024, ensures biosafety and democratic governance, prioritizing public health, environmental integrity, and citizens’ rights while fostering innovation. It aligns with global standards, including the Cartagena Protocol (2003) and Nagoya-Kuala Lumpur Supplementary Protocol (2010), and establishes the Independent Ethics Committee (IEC) for ethical oversight, particularly in human health and genetic modification.