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Government is mulling over to amend Schedule V of the Drugs and Cosmetics Act, 1940 to clear the confusion between dietary supplements, multi-vitamins and drugs. However, submissions made by the industry 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).
As of today, Schedule V under the Drugs and Cosmetics Act covers proprietary medicines and patented drugs. Schedule V stipulates standards for patent or proprietary medicines, containing vitamins for prophylactic, therapeutic or paediatric use. As per the standards, it shall contain the vitamins in quantities not less than and not more than those specified in single or in two divided daily doses.
This comes at a time when Central Drug Standards Control Organisation (CDSCO) has formed a high level committee of subject matter experts to frame an exclusive schedule of over-the-counter (OTC) drugs.
A high level joint committee comprising of experts from Central Drugs Standard Control Organisation (CDSCO) and the Food Safety and Standards Authority of India (FSSAI) had also been set up to classify products as ‘nutraceutical’ or ‘drug’, the case which is now being referred to Director General of Health Services (DGHS) for further review in the wake of some pharmaceutical firms marketing drugs as food supplements to evade price control.
The committee was formed to address borderline issues with claims that multi-vitamin products are not properly labelled. This was also aimed at determining efficacy of a product either as ‘nutraceutical’ or as ‘drug’. The committee was formed to seek clarity 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.
A senior CDSCO official said that the regulatory authorities want a science based evaluation on the matter which is taking time.
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.
The industry says, “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.”
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