CDSCO & FSSAI will classify “Nutraceutical” or “Drug”

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Against the backdrop of pharma firms marketing drugs as food supplements to escape the price control, a joint committee comprising experts from Central Drugs Standard Control Organisation (CDSCO) and the Food Safety and Standards Authority of India (FSSAI) will soon come out with a science based classification which will help determine efficacy of a product either as ‘nutraceutical’ or as ‘drug’.

This comes close on the heels of industry recommendations to the Drugs Controller General of India (DCGI) seeking clarity on the matter with reference to examining the validity of claims made on the labels of some vitamin supplements. “In order to expedite the case, some new experts have also been appointed in the committee to arrive at science based evaluation on the much awaited issue,” said Dr G N Singh, DCGI.

There were some borderline issues with claims that these multi-vitamin products are not properly labelled. The expert committee is expected to clear the confusion whether the labelling on products is a marketing gimmick or is proper as per the requirements for its intended use to be defined as a drug or food.

“It is a sensitive issue and the committee having experts from food and drugs are working to ascertain that wherever therapeutic level ingredients are used, it would fall under the category of drug, if not then it would be categorised as nutraceuticals or other food product based on evaluation,” Dr Singh added.

The blurred line between drug and food supplements surfaced in 2009 when the drug price regulator National Pharmaceutical Pricing Authority (NPPA) said that pharma firms are marketing drugs as food supplements to escape the price control.

Dr Singh further said that the expert committee will help ascertain that the products and ingredients marketed are labelled on the basis of their intended effects on the human body whether therapeutic or prophylactic and to help them to be classified as drugs, vitamins or food.
Submissions made by the industry, however, say that vitamins need to be allowed both in health and nutritional supplements if they are within the recommended dietary allowance (RDA) stipulated by Indian Council of Medical Research (ICMR). It further elaborates that the issue is more of recognizing RDA as the basis and not the ceiling in daily intakes of nutrients. If vitamins are removed from health supplements, it will have far reaching effects on the health of the consumers. The submission recommends that vitamins should be allowed both in food as well as drug, depending on the dosages employed.

A Drugs Technical Advisory Board (DTAB) subcommittee that was assigned to distinguish between vitamins as health supplements or drugs proposed, and was accepted by DTAB in its 68th meeting in June 2015, that all vitamins incorporated in a product, and having a quantity as mentioned in Schedule V (prophylaxis or therapeutic) under Drugs and Cosmetics Act, will imply that the formulation concerned is a drug.

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