Indian Drug Manufacturers Association (IDMA) has made a detailed submission to Drug Controller General of India (DCGI) on the report of the DCGI subcommittee regarding classifying certain products under food as ‘nutraceutical’ or as ‘drug’. The submission 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.
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.
According to an IDMA official, “This committee, it must be noted did not have any representative from National Institute of Nutrition (NIN), Indian Council of Medical Research (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.”
DCGI had set up an expert committee to examine the validity of the claims made on the labels of some of the high profile vitamin supplements marketed in the country for some years. Its purpose was to review these products which are currently classified as food products with exemption from stringent marketing and pricing rules. Among the 10 products that were being examined include Pfizer's 'Ferradol', Alkem Pharma's 'A to Z' and Sun Pharma's 'Revital'.
Vitamins are widely used as dietary supplements. They are commonly prescribed by physicians as a concomitant medication for mild illness to severe chronic illnesses. It is believed that they help in enhancing immunity, improve well being and aid in faster recovery of the illness. Vitamins are defined as organic substances that must be provided in small quantities because they either cannot be synthesised de novo in human body or their rate of synthesis is inadequate for maintenance of health. They are also self-prescribed by healthy people for enhancing their health, supplementing nutrition and prevention of minor ailments.