Right to Safe Food Reaffirmed: Rajasthan High Court Compels FSSAI to Regulate Genetically Modified Foods.

Introduction

In a landmark judgment underscoring the constitutional significance of food safety, the Rajasthan High Court in Kritesh Oswal & Ors. v. Union of India & Ors. has directed the Central Government and the Food Safety and Standards Authority of India (FSSAI) to urgently frame and notify comprehensive regulations governing genetically modified (GM) foods under Section 22 of the Food Safety and Standards Act, 2006 (FSS Act).

The Court held that India currently operates in a regulatory vacuum, permitting GM food products to enter the supply chain without any standardized scientific evaluation. This, the Court emphasised, violates the fundamental right to life and health under Article 21.

Reaffirming the State’s constitutional duty under Article 47 to improve public health and nutritional standards, the Bench observed that food safety must precede food security, and that scientific advancements such as biotechnology must align with the precautionary principle and constitutional morality.

Background of the Case

The PIL filed by Kritesh Oswal and others raised serious concerns regarding:

• the unregulated sale, import, and distribution of GM foods,
• the absence of notified regulations despite statutory mandates, and
• the potential health risks posed by untested GM ingredients in everyday food items.

The petitioners highlighted that Section 22 of the FSS Act expressly prohibits the manufacture, sale, and import of GM foods except in accordance with regulations. Yet, for more than a decade, no such regulations had been implemented.

The case drew attention to:

• CSE’s independent testing, which detected GM ingredients in Indian food products,
• parliamentary committee reports acknowledging regulatory gaps, and
• the Genetic Engineering Appraisal Committee (GEAC) continuing to grant approvals for GM imports despite losing statutory authority in 2007.

The Government admitted that while the Draft GM Food Regulations, 2022 had been issued, they were pending finalization. Thus, the legal question before the Court was whether GM foods could be allowed into the Indian market in the complete absence of a regulatory framework.

Issues Before the Court

The Court examined three key questions:

1. Whether FSSAI and the Central Government are under a statutory obligation to notify regulations governing GM foods under Section 22 of the FSS Act.
2. Whether GM food products can be lawfully manufactured, imported, sold, or distributed without such regulations in place.
3. Whether Rule 6(7) of the Legal Metrology (Packaged Commodities) Rules, 2011—which mandates GM labelling—is consistent with or ultra vires the FSS Act.

Court’s Observations and Key Findings

The Court undertook a comprehensive analysis of domestic laws, international treaties, and constitutional provisions.

1. A Clear Regulatory Vacuum

Despite Section 22(2) coming into force in November 2021, no GM food regulations had been operationalised. This inaction created:

• uncertainty in regulatory oversight,
• absence of safety testing standards, and
• unmonitored entry of potentially harmful GM products.

The Court termed this lacuna a serious administrative and legal gap.

2. Article 21 Protects the Right to Safe and Nutritious Food

Drawing from precedents such as:

• Centre for Public Interest Litigation v. Union of India (2016), and
• Swami Achyutanand Tirth v. Union of India (2016),

the Court held that the right to safe food is intrinsic to the right to life, and the State cannot allow scientifically unverified products to enter the food chain.

3. Article 47 – Duty of the State

Under Article 47, the State must:

• enhance public health,
• ensure food safety, and
• prevent exposure to unsafe consumables.

The prolonged delay in notifying regulations was held to be a breach of constitutional responsibility.

4. International Obligations – Cartagena Protocol

As a party to the Cartagena Protocol on Biosafety, India must:

• regulate genetically modified organisms (GMOs),
• conduct scientific risk assessments, and
• implement clear labelling and traceability standards.

The absence of GM food regulations is inconsistent with these obligations.

5. Precautionary Principle

The Court invoked the precautionary principle, holding that where scientific uncertainty exists regarding potential harm, regulation must err on the side of caution. Unregulated GM food, therefore, cannot be permitted.

Court’s Directions

The Court issued strong and unambiguous directions:

1. Mandatory Finalisation of GM Food Regulations

The Central Government and FSSAI must finalise and notify regulations under Section 22 within a specified timeframe.

2. Interim Bar on GM Food

Until the regulations are notified:

• no GM or genetically engineered food shall be manufactured, imported, sold, or distributed in India.

3. Strengthened Institutional Coordination

The Court directed enhanced coordination between:

• FSSAI, responsible for food standards, and
• GEAC, responsible for environmental biosafety assessments.

4. Labelling Rule Upheld

The Court upheld Rule 6(7) of the Legal Metrology Rules but clarified:

• labelling does not legitimise the sale of GM foods,
• and statutory regulations remain indispensable.

Impact and Significance of the Ruling

This judgment serves as a judicial reminder that regulatory inaction can undermine fundamental rights. Its significance lies in the following:

1. Constitutionalisation of Food Safety

Food safety is no longer just a regulatory requirement—it has been reaffirmed as a constitutional guarantee under Article 21.

2. Filling a Long-Standing Regulatory Void

For over a decade, India has lacked a statutory framework on GM foods. The Court’s intervention compels the regulator to act decisively.

3. Strengthening Public Trust

By prioritizing consumers’ health and safety, the judgment enhances public confidence in India’s food governance mechanisms.

4. Aligning India with International Standards

The ruling brings India’s practices closer to international biosafety norms, especially under the Cartagena Protocol.

5. Balancing Innovation and Precaution

The judgment does not reject biotechnology; it merely demands regulated, science-driven, and transparent adoption.

Author’s Analysis

The Rajasthan High Court’s decision marks a pivotal turning point in India’s food safety landscape. By compelling the FSSAI to regulate GM foods, the Court has restored primacy to human health, constitutional rights, and scientific due diligence.

The ruling effectively bridges the gap between constitutional protection and technological advancement, ensuring that scientific progress does not outpace the regulatory safeguards necessary to protect public health.

Going forward, the FSSAI must:

• expedite the notification of GM food regulations,
• create robust national laboratories for GM detection,
• enforce strict monitoring at import points, and
• adopt transparent public consultation mechanisms.

Ultimately, the judgment reinforces a fundamental truth: The right to safe, wholesome food is inseparable from the dignity and quality of human life, and no regulatory vacuum can be allowed to compromise that right.

Footnotes

1. Kritesh Oswal & Ors. v. Union of India & Ors., D.B. Civil Writ (PIL) No. 9095/2019
2. Centre for Public Interest Litigation v. Union of India, (2016) 16 SCC 279
3. Swami Achyutanand Tirth v. Union of India, (2016) 9 SCC 699

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Annexure – 1

Here’s a comprehensive compliance checklist for FSSAI based on the Rajasthan High Court ruling in Kritesh Oswal & Ors. v. Union of India & Ors. and existing statutory obligations under the Food Safety and Standards Act, 2006 (FSS Act). This is designed to help FSSAI operationalize GM food regulations and ensure regulatory readiness.

FSSAI Compliance Checklist for Genetically Modified (GM) Foods

1. Regulatory Finalization

• Draft Notification Review: Verify that the GM Food Regulations, 2022 draft is complete and incorporates public feedback.
• Legal Vetting: Ensure regulations comply with Section 22 of the FSS Act, 2006, and other relevant statutes.
• Time-bound Notification: Set a firm deadline for official notification of GM food regulations.
• Internal Approval: Obtain clearance from the Ministry of Health and Family Welfare and Cabinet approval if required.

2. Interim Measures

• Ban on Unregulated GM Foods: Issue circulars to temporarily prohibit manufacture, import, sale, and distribution of GM foods until regulations are notified.
• Public Awareness: Launch campaigns informing stakeholders about the interim restrictions.
• Port Surveillance: Ensure that import checkpoints enforce the interim prohibition.

3. Coordination with GEAC

• Joint Protocol Development: Develop integrated risk assessment protocols for GM foods.
• Approval Synchronization: Align FSSAI testing and GEAC biosafety approvals.
• Monitoring Mechanism: Establish a centralized monitoring system for GM imports, testing, and approvals.
• Periodic Reporting: Set up reporting lines between FSSAI and GEAC to review compliance and approvals.

4. Scientific Evaluation and Risk Assessment

• Standard Operating Procedures (SOPs): Draft SOPs for toxicity testing, allergenicity testing, and nutritional assessment of GM foods.
• Accredited Testing Labs: Designate and accredit labs for GM detection and quality testing.
• Research Collaboration: Engage with scientific institutions to monitor emerging GM technologies.
• Precautionary Principle: Incorporate risk-averse measures in the regulatory framework.

5. Labelling and Consumer Transparency

• Rule 6(7) Compliance: Ensure GM labelling guidelines are aligned with Legal Metrology Rules, 2011.
• Consumer Awareness: Create public education campaigns explaining labelling, risks, and regulatory safeguards.
• Inspection Protocols: Train enforcement officers to verify labelling accuracy in the supply chain.

6. Enforcement and Monitoring

• Inspection Mechanisms: Strengthen field inspection units for retail, manufacturing, and import hubs.
• Violation Reporting: Develop a grievance redressal system for complaints regarding unregulated GM food.
• Recall Procedures: Prepare standard protocols for recall of non-compliant GM products.
• Penalties: Update enforcement manuals to include penalties for violations consistent with FSS Act provisions.

7. Record-Keeping and Documentation

• Import Records: Maintain detailed records of all GM food imports.
• Testing Logs: Document test results, approvals, and lab certifications.
• Audit Trails: Ensure all regulatory actions are auditable and transparent.

8. Public Consultation and Feedback

• Stakeholder Engagement: Involve industry, consumer groups, and scientific experts in consultation processes.
• Feedback Mechanisms: Provide platforms for public comments and objections prior to finalization.
• Periodic Review: Commit to reviewing and updating regulations based on new scientific evidence.

9. International Compliance

• Cartagena Protocol Alignment: Ensure all regulations are consistent with India’s biosafety obligations under international law.
• Cross-border Monitoring: Track GM food imports from countries with approved GM crops.
• Trade Communication: Coordinate with customs and trade authorities for compliance verification.

10. Training and Capacity Building

• Regulatory Staff Training: Train officers on GM risk assessment, labelling, and inspection protocols.
• Lab Personnel Training: Ensure lab technicians are skilled in GM detection technologies.
• Awareness Programs: Conduct workshops for stakeholders in the food industry on compliance requirements.

This checklist ensures FSSAI can implement the Rajasthan High Court directive effectively, uphold Article 21 rights, and maintain international biosafety standards.