A Gujarat-based NGO has urged the government to bring nutraceuticals, including fortified foods and health supplements, under the ambit of drug regulators by implementing the recommendations of a 2024 inter-ministerial committee, citing concerns over product quality and unregulated pricing.

In a representation to Union Health Minister JP Nadda, the organisation 'Right to Life' said the current regulatory framework, which classifies nutraceuticals as food products under the Food Safety and Standards Authority of India (FSSAI), has led to a "serious dilution" of manufacturing standards and oversight.

The NGO argued that many nutraceuticals are routinely prescribed by doctors across specialties such as cardiology, orthopaedics and gynaecology as adjunct therapeutic interventions, and are dispensed through pharmacies in a manner similar to prescription drugs.

"Patients have a reasonable expectation that such products meet pharmaceutical-grade quality and safety standards. However, their classification as food items results in weaker regulatory scrutiny," the representation stated.

The representation has also been posted by the NGO on its X handle @RighttoLife_Org.

It further claimed that unlike drugs regulated by the Central Drugs Standard Control Organisation (CDSCO), nutraceuticals are not subject to mandatory pre-market batch testing, pharmacopoeial standards or strict labelling compliance, increasing the risk of substandard or mislabelled products.

Citing studies and regulatory analyses, the NGO alleged the presence of widespread issues such as adulteration, incorrect dosages and undeclared ingredients in nutraceuticals sold in India, with limited post-market surveillance mechanisms.

The representation also raised concerns over pricing, noting that nutraceuticals are currently outside the purview of the National Pharmaceutical Pricing Authority (NPPA) following their reclassification under the Food Safety and Standards Act.

"This has enabled unchecked price escalation, with several commonly prescribed nutraceutical formulations witnessing increases of 200 to 300 per cent or more, compared to capped price hikes of around 10 per cent annually for essential drugs under the Drug Price Control Order (DPCO)," it said.

The NGO said such price increases disproportionately affect vulnerable sections, including elderly patients, those with chronic conditions and pregnant women who rely on supplements like iron, folic acid and omega-3 formulations.

Referring to the findings of the 2024 inter-ministerial committee, it said the panel had recommended that nutraceuticals making disease risk reduction (DRR) claims should be regulated under the CDSCO instead of the FSSAI.

The committee had also called for stricter Good Manufacturing Practice (GMP) requirements for such products and suggested limiting FSSAI's jurisdiction to nutritional and general health claims that do not pertain to specific diseases.

"The recommendations recognise that nutraceuticals making therapeutic claims are functionally akin to drugs and warrant pharmaceutical-grade regulation," the NGO said.

It urged the government to restore CDSCO oversight for such products, mandate WHO-GMP compliance for manufacturers and reinstate NPPA price controls to prevent exploitative pricing.

The NGO warned that failure to address these regulatory gaps could continue to compromise public health and impose significant financial burden on patients.

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