Rajasthan High Court Restrains Manufacture, Sale Or Import Of 'Genetically Modified' Foods Till Centre Frames Regulations
Rajasthan High Court has restrained the Food Safety Standards Authority of India and Environment Ministry's Genetic Engineering Appraisal Committee from granting permission for sale, manufacture, distribution or import of Genetically Modified (GM) Food till regulations are framed governing such items. The court also directed the FSSAI and the Centre to frame the requisite regulations governing...
Rajasthan High Court has restrained the Food Safety Standards Authority of India and Environment Ministry's Genetic Engineering Appraisal Committee from granting permission for sale, manufacture, distribution or import of Genetically Modified (GM) Food till regulations are framed governing such items.
The court also directed the FSSAI and the Centre to frame the requisite regulations governing GM foods/edible items under Section 22 of the Food Safety Act within 6 months. Section 22 of the Act provides that except for in accordance with the regulations made under the Act, no one shall manufacture, distribute, sell or import any GM food.
The division bench of Acting Chief Justice Mr. Sanjeev Prakash Sharma and Justice Sanjeet Purohit issued the following directions:
(i) The respondent-FSSAI as well as the Union of India are directed to implement Section 22 of the Act of 2006 in its true letter and spirit and to provide standards and safety protocols regarding genetically modified / genetically engineered articles of food in a time bound manner.
(ii) The respondent-FSSAI as well as the Union of India are directed to frame and notify the regulations under Section 22 of the Act of 2006 regarding GM articles of food, after following the procedure provided under the Act of 2006, preferably within a period of six months from today.
(iii) The FSSAI as well as GEAC are restrained for granting any permission for sale, manufacture, distribute or import of any genetically modified foodstuffs / edible items in India without first framing the regulations under Section 22 of the Act of 2006.
(iv) The FSSAI as well as Union of India are directed to ensure that no import of any food-stuff / edible items / packaged food shall be permitted unless they have been certified and labelled to be “GM free”, by the exporting country.
(v) The customs authorities as well port authorities across the State are directed to ensure strict compliance of the above mentioned directions.
The court said: “It is astonishing that while the issue of genetically modified organisms in edible products is a matter of significant concern, yet the relevant regulations have not been finalized and notified by the Central Government. Although The FSSAI has been established, yet the GEAC has been allowed to approve the import of GM edible oil in India under the “Abeyance Notifications,” solely due to the absence of regulations under Section 22 of the 2006 Act.”
The Court was hearing a public interest litigation that highlighted the side-effects of GM Food on human body, and the absence of regulations as envisaged under Section 22 of the Act.
It was contended that since GM food was permitted to be imported in India by GEAC, without any scientific research or impact assessment on human body, it was violative of Right to Health under Article 21.
After hearing the contentions, the Court perused the statutory framework as well as international conventions on the matter, and dealt with the matter in 2 limbs.
Urgent Need for Regulations under Section 22 of the Act.
While expressing surprise over the lack of regulations under Section 22 of the Act despite GM foods being such a significant matte of concern, reference was made to the Supreme Court case of Vandana Shiva v Union of India. It was opined that it was clearly held therein that any activity in relation to GM foods was permissible only after regulations were framed under Section 22 of the Act.
The Court further highlighted that apart from statutory obligations, India was also signatory to the United Nations Convention on Biological Diversity (UNCBD) 1992, read with the Cartagena Protocol and thus under an obligation for providing statutory regime in this regard.
Furthermore, reference was made to certain precedents, and the Court held that, “We are also in agreement with the contention of the petitioner that the absence of food safety protocols regarding GM food as well as regulatory mechanism is violative of Article 21 of the Constitution of India.”
After analyzing the statement of Objects and Reasons of the Act, the Court stated that the Statements revealed the intent behind introducing a special food legislation, with a distinct emphasis on GM Food. Despite that, the objective of regulating GM Foods had remained unfulfilled owing to State's failure to frame necessary regulations.
“The impact of GM foods on human health has long been a topic of global scientific debate. While definitive conclusions remain elusive, the potential for adverse health effects cannot be ruled out. Research has indicated that GMOs in food products may lead to various health concerns, including toxicity, allergic reactions, antibiotic resistance, immunosuppression, cancer, and nutritional deficiencies.”
The Court observed that the need for establishing such regulatory framework for GM foods was rooted in Precautionary principle, and such substantial gaps in the framework had put public confidence and food safety at risk. Hence, the framing of such regulations was not only important but also critically necessary.
In this background, the Court highlighted that even though court's writ jurisdiction did not allow it to issue mandamus to the State for enacting a legislation, one exception was carved by the Apex Court in Union of India v K. Pushpavanam wherein unless a rule-making power was exercised, the legislation could not be implemented.
Hence, the Court directed the State to implement Section 22 in its true letter and spirit and issued mandamus to frame the required regulations on GM Foods preferably within a period of 6 months.
“…it is imperative for the authorities under the Act of 2006 to frame the regulations envisaged under Section 22. The position remains paradoxical, while the import of genetically modified edible items is permitted but the corresponding regulatory framework has not been formulated even after the lapse of two decades. This continued inaction has rendered Explanation 2 of Section 22 virtually otiose and, more gravely, has deprived the citizens of their fundamental right to food safety, an integral facet of Article 21 of the Constitution.”
Permission/Approval to GM Foods by GEAC
The Court observed that the regulatory scope of GEAC was limited to matters concerning environmental safety, while the scope of food safety was within the domain of FSSAI under the Act.
Since Section 22 was explicit about the fact that no approval or permission could be granted for manufacture, sale, storage, import or related activities related to GM foods, unless it was in accordance with the regulation, such regulation being in place was a sine qua non for granting any such approval.
Hence, no permission or approval in relation to sale, manufacturing, distribution or import of GM Foods could be validly and lawfully granted, unless the requisite regulations under Section 22 of the Act were brought into effect.
“Food safety, cannot be seen as a mere regulatory or market issue, rather its a constitutional imperative enshrined under Article 21 aimed at protecting public health and securing a dignified quality life to every citizen. The Current Population of nearly 1.46 billion, poses enormous responsibility upon the State to ensure health and well being of its citizens. Despite numerous progressive steps, even today, for millions of households, affordability of food still outweighs the food safety.”
The Court observed that vulnerable populations, battling poverty and low literacy, could not be expected to make informed choices about their food consumption in absence of specific regulations providing clear labeling, transparent studies, public awareness and safety assurances.
Therefore, it was imperative that import of any edible food items in India be allowed only after production of a “GM-Free Certificate” issued by the competent authority of the exporting country.
Hence, it was necessary to restrain any authorities from granting permission/approval to sale, manufacturing, distribution or import of GM foods in India, in absence of the requisite regulations.
Case Title: Kritesh Oswal & Ors. v Union of India & Ors.
Citation: 2025 LiveLaw (Raj) 355
Counsels for Petitioners: Mr. Kritesh Oswal, present in person; Mr. Pratyush Sharma
Counsels for Respondents: Mr. Devesh Yadav with Mr. Yatharth Asopa & Mr. Chinmay Surolia for Mr. R. D. Rastogi, ASG; Ms. Priya Khushalani for Mr. Mudit Singhvi