Introduction

As per an article published on 16 July 2024 in Economic Times[1], nutraceutical companies are opposing the proposal of the Indian Government to bring nutraceuticals under the regulatory framework of drug regulations.

Nutraceuticals are supposed to be products derived from food sources that provide extra health benefits beyond basic nutrition. They include dietary supplements, functional foods, and products that claim to prevent or treat diseases or enhance health and well-being. In India, the regulatory framework for nutraceuticals primarily falls under the purview of the Food Safety and Standards Authority of India (FSSAI) and the Ministry of Health & Family Welfare (MoHFW).

Current Regulatory Framework

The FSSAI regulates nutraceuticals by way of laws, standards, regulations and guidelines, the major ones being Food Safety and Standards Act, 2006 (the “FSS Act”) and the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022 as amended from time to time (the “Nutraceutical Regulations”). As the law stands today, companies are required to license their nutraceutical products under the FSS Act (“Food License”) and have to comply with the labelling requirements, additive limitations and claims restrictions as per the Nutraceutical Regulations.

Proposed Shift in Regulatory Framework

Way back in July 2012, the Report of the 44th Meeting of the Drugs Consultative Committee was released (the “Report”) which raised the issue that various non-pharmaceutical companies are manufacturing supplements with vitamins that fall in the quantity specified under the Schedule V of the Drugs Rules, 1945 (the “Drugs Rules”). The Report went on to state that the supplements that are manufactured as per the dosage defined in the Drugs Rules should be licensed under the Drugs Rules (“Drug License”) instead of the FSS Act making the regulation of nutraceuticals more stringent. However, no shift in regulatory framework was implemented based on the Report.

Recently, in February of 2024, the Central Government formed another committee to analyse specifically whether nutraceuticals should be regulated by FSSAI or by the Central Drugs Standard Control Organisation (CDSCO). This move comes as a response to concerns of claims of disease management and other health benefits made by nutraceutical manufacturers. Also, due to overlapping of ingredients in a nutraceutical product and those covered under Drugs Rules, there have been reports of manufacturer changing their license from Drug License to Food License for ease of compliance and less stringent marketing regulations.

A license under the Drugs Rules would require the manufacturer to adhere to a standard of manufacturing practice, increase quality assurance and regulate the claims that can be made for nutraceuticals manufactured under Drug License. For instance, in a study[2] conducted on 36 different protein supplements marketed and sold in India, it was found that 69.4% of the protein supplements were mislabelled with regard to the protein content, i.e., the protein content in analysis was less than what was advertised on the product. It is claimed by many that these kinds of false claims and mislabelling would not be possible if nutraceuticals are regulated as drugs, since CDSCO has stricter standards of testing, manufacturing practices and restrictions on making claims.

Industry Reaction

The nutraceutical companies have not welcomed this proposal of regulating nutraceuticals as drugs. Various industry bodies have opposed this proposal stating that FSSAI regulations are already in alignment with global industry practices. On the issue of exaggerated health claims, the industry bodies stated that FSSAI can make stricter regulations to combat the issue. It is further claimed that shift from FSSAI to CDSCO would impact the nutraceutical industry since such a move would require a long transition period and will introduce uncertainty in the market.

There are several views which are for and against this proposed move of the government, however the larger interest of the society must prevail.


Disclaimer: The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.


Authored by Nusrat Hassan, Managing Partner, India, Pradnesh Warke, Partner, and Ravi Shekhar, Associate, Dentons Link Legal.


[1] Thacker, Teena. (2024, July 16). Pharma companies against plan to bring nutraceuticals under drug regulator. The Economic Times. https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/pharma-companies-against-plan-to-bring-nutraceuticals-under-drug-regulator/articleshow/111791989.cms?from=mdr

[2] Phillips, Cyriac Abby, Theruvath, Arif & Ravindran, Resmi (2024). Citizen Protein Project. Medicine - National Library of Medicine, 103(14).