New Delhi: The drugs price regulator has written to the ministry of health and family welfare requesting action against drugs being sold as vitamin supplements.
The move comes soon after concern was raised over Merck Ltd, India, a subsidiary of Germany-based Merck KGaA, taking out its vitamin E product Evion out of the category of drugs and began selling it as a dietary supplement.
The National Pharmaceutical Pricing Authority (NPPA) has written to the health ministry, asking it to initiate action against drugs being sold as food supplements, said a senior official at the NPPA, who didn’t want to be identified.
Health check: A medical store. Vitamin products are not required to comply with quality standards mandated by drug laws. Hemant Mishra / Mint
Vitamins that fall under the category of drugs, in line with the Drugs and Cosmetics Act, should not be categorized as dietary supplements, according to the case made by NPPA to the ministry.
Concern was raised after Merck, which was previously selling its Evion 200mg and 400mg vitamin E pills as a drug under the Drugs and Cosmetics Act with a manufacturing licence from Goa, obtained a licence from the Food Authority of Daman and began selling the product as a dietary supplement at at least five times the price.
The company changed the ingredients in Evion, adding, besides the existing vitamin E, wheat germ oil and omega fatty acids.
“We are seized of the matter,” said A.K. Banerjee, chairman of NPPA, when contacted for comment on the matter. He declined to elaborate.
Prices of some essential bulk drugs that are approved for manufacture and sale under the Drugs and Cosmetics Act are fixed by NPPA in line with the Drug Prices Control Order, 1995. Vitamin E falls under this category and prices of all drugs containing vitamin E are fixed by the drugs price regulator.
The authority requested action under the Prevention of Food Adulteration Act (PFA Act), which has been replaced by the recently notified Food Safety and Security Act of 2006.
“The PFA Act checks quality of food-based products. Such vitamin products are not required to comply with quality standards mandated by drug laws,” said Chandra M. Gulhati, editor of the Monthly Index of Medical Specialties, a journal containing information on prescription drugs in India.
“As a result, if consumers of Evion are hurt by poor quality, they have little choice except to suffer. Consequently, Evion is not subject to any regulation on pricing, promotion or quality,” said Gulhati, adding that the ministry of health can rule that vitamins that had been classified as drugs should comply with the Drugs and Cosmetics Act.
Merck was able to increase the price of Evion once it began selling it as a dietary supplement under another licence.
“Legally, Merck is safe. But ethically, to market a product that was earlier a drug, under the same brand name as a food supplement now is absolutely wrong. It misleads the consumer, who thinks he is taking a drug but is actually taking a supplement,” said the same NPPA official.
When contacted, a Merck official would only say that Evion and the version being marketed as a food supplement “are two different products, both of which have the requisite licences and approvals for their production and marketing”.
However, when a Mint reporter approached chemists to buy Evion 400mg, there was only one product available—the dietary supplement.
“We have taken up the cases of other products also that fall under the category of dietary supplements,” said the same NPPA official, citing as examples Ranbaxy Laboratories Ltd’s Revital and A to Z by Alkem Laboratories Ltd.
“Any vitamin supplement that has ingredients that fall under the category of a drug should come under the Drugs and Cosmetics Act since, currently, there is no quality or price control for such supplements outside the act,” said the official.
India’s market for nutraceuticals, a term coined from nutrition and pharmaceuticals and taken to mean food or food extracts that provide medical benefits, is estimated to increase from Rs1,875 crore in 2007 to Rs2,700 crore in 2009, according to Cygnus Research.