The National Pharmaceutical Pricing Authority (NPPA) has submitted a set of proposals, including necessary amendment in the Drugs and Cosmetics Rules, to the Health Ministry to plug loopholes in the regulatory system under which some companies dodged price control norms by adding ingredients not listed under the law relating to drugs and cosmetics.

The NPPA has taken up the issue with the Health Ministry and pointed out that some companies were resorting to the tactics of mixing food and nutrition supplements with certain drug formulations so as to circumvent the price control mechanism. NPPA had collected samples from the market to examine the allegations in this regard.

"The NPPA has suggested some corrective measures to be implemented in consultation with the Drugs Consultative Committee and the Central Committee on Food Standards, which, if needed, could be appropriately incorporated in the provisions of the Drugs and Cosmetics Rules, 1945 and the Prevention of Food Adulteration Rules, 1955," an official of the health ministry said. The matter has been referred to the CDSCO so that it can be taken up in the DCC meeting, he said.

It may be noted that in one of such cases, Merck India Ltd had classified its leading vitamin E brand, Evion 400 tablets, into a dietary supplement just to come out of price control. The company obtained the product license with change in the composition from drug authorities of Daman.

While the ceiling price of a strip of 10 tablets of Evion 400 tablets fixed by the NPPA was Rs 14.82 inclusive of all taxes, the company after changing the product from a drug to a dietary supplement has fixed the MRP at Rs 60 for a strip of 10 tablets. Interestingly, the company did not change the brand name and retained its name as Evion 400 and fixed the MRP at Rs 60 against Rs 14.82. Evion 400mg is a leading vitamin E product in the country.