NEW DELHI, 15 MAY:
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.
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