NEW DELHI: A Gujarat-based NGO has urged the government to bring nutraceuticals, including fortified foods and health supplements, under the ambit of drug regulatory bodies by implementing the recommendations of an inter-ministerial committee for 2024, citing concerns over product quality and unregulated pricing.
In a report to Union Health Minister JP Nadda, Right to Life said the current regulatory framework, which classifies nutraceuticals as food products under the Food Safety and Standards Authority of India, has led to a “dangerous dilution” of manufacturing and oversight standards.
The NGO said that many nutrients are routinely prescribed by doctors in specialties such as cardiology, orthopedics and gynecology as ancillary therapeutic interventions, and are dispensed through pharmacies in a manner similar to prescription medications.
“Patients have a reasonable expectation that these products meet pharmaceutical quality and safety standards. However, their classification as food substances results in weaker regulatory scrutiny,” the representation stated.
The NGO also published the representation on its X index @RighttoLife_Org.
It also claimed that unlike drugs regulated by the Central Drugs Standards Control Board, nutraceuticals are not subject to mandatory pre-marketing batch testing, pharmacopoeia standards or strict labeling compliance, which increases the risk of substandard or mislabeled products.
Citing regulatory studies and analyses, the NGO alleged widespread problems such as adulteration, incorrect dosages and undeclared ingredients in nutraceuticals sold in India, with limited post-market monitoring mechanisms.
The representative also raised concerns about pricing, noting that nutraceuticals currently fall outside the jurisdiction of the National Pharmaceutical Pricing Authority following its reclassification under the Food Safety and Standards Act.
“This has enabled unchecked price escalation, with many commonly prescribed formulations seeing increases of 200 to 300 per cent or more, compared to price rises set at around 10 per cent per year for essential medicines under the Drug Price Control Order,” she said.
The NGO said such price increases disproportionately affect vulnerable groups, including elderly patients, people with chronic diseases and pregnant women who rely on nutritional supplements such as iron, folic acid and omega-3 formulas.
Referring to the findings of the 2024 Inter-Ministerial Committee, she said the committee recommended that food items making disease risk reduction claims should be regulated under CDSCO instead of FSSAI.
The committee has also called for more stringent Good Manufacturing Practice requirements for such products and suggested limiting the FSSAI’s jurisdiction to nutritional and public health claims that do not relate to specific diseases.
“The recommendations recognize that nutraceuticals making therapeutic claims are functionally similar to drugs and require pharmaceutical-grade regulation,” the NGO said.
She urged the government to restore CDSCO oversight of such products, require manufacturers to comply with the WHO and GMP and reimpose price controls on the NPPA to prevent exploitative pricing.
The NGO warned that failure to address these regulatory loopholes could continue to jeopardize public health and impose a significant financial burden on patients.
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