NEW DELHI: The government is planning a crackdown on drug companies selling medicines under the garb of dietary supplements, which are not regulated.
Senior officials in the department of pharmaceuticals and the health ministry said several drug makers have secured approval for drugs as dietary supplements under the Prevention of Food Adulteration Act, where price and other regulations on drugs do not apply.
This not only allows them to sell the product at a price more than the maximum retail price fixed by the government for the ingredient drug but also helps them avoid inspection by the authorities.
"In addition to higher cost, there is also a health issue as they are being advertised aggressively as normal health products and there can be side effects if people use them indiscriminately," a senior health ministry official said. Popular among the dietary supplements available in India are Ranbaxy's Revital, Piramal Healthcare's Supractive, Dabur India's Nutrigo and Modicare's Well multi-vitamin.
The nutraceuticals segment in India is expected to touch $5 billion by 2015, from $2 billion at present.
Dietary supplements are big revenue earners for drug makers. For instance, Revital rakes in over 180 crore a year for Ranbaxy Laboratories and is also the company's best-selling product in India.
Some experts say that while the chances of harmful side effects of dietary supplements are minimal-as they contain drugs in sub-therapeutic levels-a bigger problem is that these products and their manufacturing processes are not inspected for efficacy or quality.
"They are registered as food products and there is no inspection at all. Under Indian laws, they should be medicines. After all, they contain several drugs," said C M Gulati, a Delhi-based drug expert. In India, the government fixes the retail price of medicines that contain ingredients under price control.
According to Piramal Healthcare director Swati Piramal, the quantity of drugs in Supractive is less than the dosage recommended for therapy and, therefore, worries over harmful side effects due to overuse are unfounded.
Piramal said that price control and advertisement ban should be removed for dietary supplements and drugs that are used to treat illnesses caused due to deficiency, such as anaemia. "A large section of the population suffers from deficiency of key vitamins and nutrients," she said.Ranbaxy declined o comment on the matter.
Most food and health supplements contain vitamins A, B1, B2, C and E, which are among the 74 drugs whose prices are fixed by the National Pharmaceutical Pricing Authority (NPPA), the drug price regulator.
The Department of Pharmaceuticals and the NPPA have now taken up the matter with the Drug Controller General of India (DCGI) and food regulatory bodies to plug this loophole.
According to an official of the Food Safety and Standards Authority of India, experts will examine whether such products are being used as drugs or supplements, and those qualifying as drug will be brought under price control.
Senior officials in the department of pharmaceuticals and the health ministry said several drug makers have secured approval for drugs as dietary supplements under the Prevention of Food Adulteration Act, where price and other regulations on drugs do not apply.
This not only allows them to sell the product at a price more than the maximum retail price fixed by the government for the ingredient drug but also helps them avoid inspection by the authorities.
"In addition to higher cost, there is also a health issue as they are being advertised aggressively as normal health products and there can be side effects if people use them indiscriminately," a senior health ministry official said. Popular among the dietary supplements available in India are Ranbaxy's Revital, Piramal Healthcare's Supractive, Dabur India's Nutrigo and Modicare's Well multi-vitamin.
The nutraceuticals segment in India is expected to touch $5 billion by 2015, from $2 billion at present.
Dietary supplements are big revenue earners for drug makers. For instance, Revital rakes in over 180 crore a year for Ranbaxy Laboratories and is also the company's best-selling product in India.
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"They are registered as food products and there is no inspection at all. Under Indian laws, they should be medicines. After all, they contain several drugs," said C M Gulati, a Delhi-based drug expert. In India, the government fixes the retail price of medicines that contain ingredients under price control.
According to Piramal Healthcare director Swati Piramal, the quantity of drugs in Supractive is less than the dosage recommended for therapy and, therefore, worries over harmful side effects due to overuse are unfounded.
Piramal said that price control and advertisement ban should be removed for dietary supplements and drugs that are used to treat illnesses caused due to deficiency, such as anaemia. "A large section of the population suffers from deficiency of key vitamins and nutrients," she said.Ranbaxy declined o comment on the matter.
Most food and health supplements contain vitamins A, B1, B2, C and E, which are among the 74 drugs whose prices are fixed by the National Pharmaceutical Pricing Authority (NPPA), the drug price regulator.
The Department of Pharmaceuticals and the NPPA have now taken up the matter with the Drug Controller General of India (DCGI) and food regulatory bodies to plug this loophole.
According to an official of the Food Safety and Standards Authority of India, experts will examine whether such products are being used as drugs or supplements, and those qualifying as drug will be brought under price control.
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