DCGI sets up committee to examine label claims of products sold as multi-vitamins

Drug Controller General of India (DCGI) has 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. The committee would evaluate the claims made on the ingredients of these products to help the consumer determine the intended therapeutic or prophylactic use of the products.

DCGI has formed an 8-member committee for the purpose to review these products which are currently classified as food products with exemption from stringent marketing and pricing rules. Among the 10 products that are currently being examined are Pfizer's 'Ferradol', Alkem Pharma's 'A to Z' and Sun Pharma's 'Revital'.

This move will not only help to bring effective regulations of the products but also correct the anomaly of multivitamins getting marketed as dietary supplements. Said Dr G N Singh, DCGI, "These relate to some of the 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. The issue has been flagged to the DCGI office in the past also and the expert group will soon come out with the scientific rationality for its better regulation."

He further said that this will help ascertain that the products and ingredients marketed are labeled 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. The committee will suitably examine the same and come out with a report soon.

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.

India's nutraceutical market is estimated to be close to $2 billion. 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. In a letter to the health ministry in the past, it cited the example of food supplements such as Ranbaxy's Revital and Germany-based Merck KgaA's vitamin E product Evion, which, it said, were earlier getting marketed as drugs.

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=90980&sid=1