Some vitamin formulations are being sold as food supplements instead of drugs, making a bigger hole in the pockets of consumers in violation of rules, according to health experts.
These formulations are being produced and sold as food supplements in order to circumvent regulations relating to drugs. All drugs are required to obtain a manufacturing licence from the drug control authorities, but food products are covered under the Prevention of Food Adulteration Act.
“Vitamins should be sold as drugs. If they are claiming to be food supplements, then it is not the truth. Anything that affects the functioning of the body is a drug,” said Dr Ranjit Roy Choudhry, clinical pharmacologist, who heads the WHO programme for rational use of drugs in India.
“What prompts the producers to portray vitamin formulation as food is the fact that while vitamins are under price control order, food supplements are not and thus can be priced high,” said Dr C. M. Gulhati from the Monthly Index of Medical Specialties.
For instance, prices of medicines that contain vitamins A, B-1, B-2, C and E are controlled by the national pharma- ceutical pricing authority (NPPA) to prevent profiteering.
Thus, while some vitamin formulations which are sold as drugs cost only around Rs 18 for 15 tablets or even less, other formulations sold as food supplements cost around Rs 75 for 10 tablets. “These brands are violating the drug Act. The drug control office and the NPPA should take action,” Gulhati said.
A similar strategy was used by a company which had started selling its vitamin E formulation as food product.
However, protests by health experts and groups had led it to declare the formulation again as a drug.
As food supplements, these formulations do not require to prove efficacy and safety through clinical studies, Gulhati said. They also need not declare the side effects.
But, vitamins are pharmacologically active substances which affect multiple organs of the body. Extra supplements are required only if there is proven deficiency and excessive intake may lead to side effects, according to experts.
Overuse of vitamin A can cause liver damage while unborn babies may develop congenital abnormalities. A study of 22,748 pregnant women in the US found that among babies born to mothers taking over 10,000 international units daily, one in 57 infants had malformation directly linked to vitamin A.