Explain the regulatory framework governing genetically modified organisms in India and assess its adequacy…

Question

Explain the regulatory framework governing genetically modified organisms in India and assess its adequacy in addressing modern challenges.

Ghissu Editorial · Accepted Answer

India regulates GMOs under the Environment Protection Act, 1986 and its 1989 Rules through tiered committees (IBSC, RCGM and GEAC), DBT biosafety guidelines and the Cartagena Protocol. It is only partly adequate, as conflicts of interest, weak state involvement and slow approvals hamper challenges like gene editing.

**Introduction**

India’s GMO regulatory framework aims to ensure biosafety and innovation amid complex agro-ecological challenges, especially in states like ==Andhra Pradesh⟦2⟧⟦1⟧==, which has significant agricultural and aquaculture activities influencing regulatory needs.

**Regulatory Framework Governing GMOs in India**

SKETCH: mindmap | GMO Regulatory Framework in India
- Legal Instruments (EPA 1986, 1989 Rules)
- Institutional Bodies (IBSC, RCGM, GEAC)
- Biosafety Guidelines (DBT, ICMR)
- International Protocols (Cartagena Protocol)
- Complementary Acts (PPVFRA, Biodiversity Act)

1. **Legal Instruments and Institutional Bodies**: The Environment Protection Act 1986 and 1989 Rules form the legal basis, with six statutory committees including IBSC, RCGM, and GEAC, the apex approval body under MoEFCC, overseeing environmental release approvals.

2. **Biosafety Guidelines and International Commitments**: DBT issues detailed biosafety protocols covering research, field trials, and risk assessments; ICMR advises on health risks. India adheres to the Cartagena Protocol on Biosafety and complements biosafety with the Protection of Plant Varieties and Farmers’ Rights Act 2001 and the Biological Diversity Act 2002.

**Adequacy of the Framework**

2. **State-Level Coordination and Innovation Challenges**: Lack of mandatory state permissions hampers field trials, critical for states like ==Andhra Pradesh== with diverse agro-climatic zones. High compliance costs and lingering questions on gene-edited products, even after SDN-1 and SDN-2 were exempted in 2022, deter innovation, delaying public-sector GM mustard (DMH-11). The Standing Committee on Agriculture recommended mandatory state involvement to improve coordination and public trust.

**Way Forward**

1. **Statutory Empowerment**: Enact a dedicated Biosafety Act creating an independent statutory regulator to give GEAC and related committees greater autonomy, ensuring transparent, conflict-free decision-making.

2. **Strengthen State Coordination**: Mandate state government involvement in approvals and field trials to address local agro-ecological diversity and improve regulatory efficiency.

**Conclusion**

While comprehensive, India’s GMO framework requires statutory backing and improved state coordination to effectively address modern biotechnological challenges and foster innovation.

Model answer

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