NGO wants nutraceuticals regulated like drugs over safety and pricing concerns

Key Update

A Gujarat-based NGO has urged the government to bring nutraceuticals, including fortified foods and health supplements, under drug regulator oversight. It cited concerns over product quality, safety, and unregulated pricing and called for implementing the 2024 inter-ministerial committee recommendations. In its representation to Union Health Minister JP Nadda, the organisation “Right to Life” said the current classification of nutraceuticals as food products under FSSAI weakens regulatory control and leads to diluted manufacturing standards. The NGO pointed out that doctors across specialities widely prescribe these products as part of treatment support, and pharmacies dispense them similarly to medicines.

Flags Gaps in Safety and Quality Checks

The group highlighted that treating nutraceuticals as food products reduces regulatory scrutiny. It noted the absence of mandatory pre-market testing, strict pharmacopoeial standards, and robust labelling requirements, increasing the risk of substandard or mislabelled products.

Raises Alarm Over Pricing and Accessibility

The NGO also raised concerns over pricing. It said nutraceuticals remain outside the National Pharmaceutical Pricing Authority’s control, leading to sharp price increases compared to regulated essential medicines. It added that these price hikes particularly affect vulnerable groups, including elderly people, patients with chronic diseases, and pregnant women who depend on supplements such as iron, folic acid, and omega-3 formulations.

Calls for Stricter Drug-Like Regulation

Referring to the 2024 inter-ministerial committee report, the NGO urged the government to bring nutraceuticals with therapeutic claims under CDSCO regulation. It also recommended mandatory WHO-GMP compliance for manufacturers and reinstatement of price controls to prevent excessive pricing. The organisation warned that continued regulatory gaps could compromise product safety and place an unnecessary financial burden on patients who rely on these supplements.

Source: Hindustan Times