Possible changes in the regulation of nutraceuticals and food supplements

An inter-ministerial committee formed by the Union health ministry has recommended amendments to the Food Safety and Standards Act, 2006 and regulations on nutraceuticals and health supplements, to shift regulation of certain items to the drug regulatory authority and bring in standards including the Good Manufacturing Practices (GMP) for health supplements and nutraceuticals.

The committee, formed earlier this year under the chairmanship of the then health secretary Apurva Chandra to look into the regulatory purview of nutraceuticals in the country, recommended that in terms vitamins, minerals and amino acid supplements, the mere combination including single use of nutrients specified in Schedule-I of Nutra regulation may not be regulated by Food Safety & Standards Authority of India (FSSAI).

Vitamin, minerals and amino acids added in food (as defined in the FSS Act 2006) (containing macronutrients such as protein, carbohydrate and fat providing significant calories), may be retained under the purview of FSSAI, but the formulations having vitamins, minerals and amino acids with dose and/or dosage formats and permitted excipients as defined in rule D&C Act shall be shifted under the purview of Central Drugs Standard Control Organisation (CDSCO).

Observing that claims related to Disease Risk Reduction (DRR) are widely used by manufacturer without approvals and often misused or manipulated, the committee suggested that the claim to cure or mitigate any specific disease, disorder or condition including DRR shall be regulated by the CDSCO, while FSSAI may regulate only nutritional and health claims that are listed under FSS (Claims and Advertisements) Regulations, 2018. The DRR claims listed under this regulation may not be applicable for products categorised under nutraceutical regulations.

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"Story Supplied courtesy of pharmabiz".