Following industry recommendations to Drugs Controller General of India (DCGI) seeking clarity on classifying products as ‘nutraceutical’ or as ‘drug’ with reference to examining the validity of claims made on the labels of some vitamin supplements, DCGI office is planning to further appoint some new experts on its committee to arrive at science based evaluation on the much awaited issue.
Says Dr G N Singh, DCGI, “It is a complex and a challenging issue not only in India but globally and we are working on a broader concept to ascertain that wherever therapeutic level vitamins are used, it would fall under the category of drug, if not then it would be categorised as nutraceuticals or other food product.”
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. If the products under scrutiny offer therapeutic claims then they will fall under drugs.
“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,” he added.
Indian Drug Manufacturers Association's recent submission, however, says 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.
According to an IDMA submission, “This committee, it must be noted did not have any representative from National Institute of Nutrition (NIN) and ICMR. DCGI called for suggestions based on the committee’s report. This move by DTAB can have far reaching consequences and can boomerang by the stakeholders refraining from including vitamins in their health supplements.”