A Gujarat-based non-governmental organisation has called on the Centre to bring nutraceuticals regulation India under stricter drug control, raising concerns about product quality issues, consumer safety risks, and pricing concerns in healthcare in the fast-growing segment.
In a letter to Union Health Minister JP Nadda, the NGO Right to Life urged the government to act on the recommendations of a 2024 inter-ministerial committee that proposed tighter oversight. At present, nutraceuticals—such as dietary supplements and fortified foods—are regulated as food products by the Food Safety and Standards Authority of India (FSSAI), limiting strict regulatory framework typically seen in pharmaceuticals.
The organisation argued that this classification has led to weaker standards compared to medicines. It noted that nutraceuticals are often prescribed by doctors and sold through pharmacies, creating an assumption of pharmaceutical-grade standards among consumers.
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Unlike drugs regulated by the Central Drugs Standard Control Organisation (CDSCO), nutraceuticals are not required to undergo pre-market testing requirements or follow detailed pharmacopoeial norms. According to the NGO, this gap increases the risk of mislabelled health supplements and substandard products reaching consumers.
The representation also highlighted issues such as adulteration, incorrect dosage levels, and the presence of undeclared ingredients. It warned that limited post-market surveillance gaps further increase risks to public health.
Pricing is another major concern. Since nutraceuticals are not covered by the National Pharmaceutical Pricing Authority (NPPA), they fall outside drug price control India norms. The NGO claimed that prices of some commonly used products have surged significantly, creating healthcare affordability challenges, especially for vulnerable groups.
To address these issues, the organisation has recommended bringing nutraceuticals—particularly those with therapeutic claims—under CDSCO oversight. It also called for mandatory WHO-GMP compliance India and introducing nutraceutical price regulation to prevent excessive pricing.
The NGO warned that without timely reforms, regulatory gaps could continue to affect both safety and affordability as India’s nutraceutical market expands rapidly.
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