MUMBAI: The Drug Controller General of India has proposed to bring some popular vitamin supplement brands under the category of 'drugs', a move that could give rise to a tussle between pharma companies and the regulator as it will mean stringent restrictions on marketing of these products.
Among the 10 products that have been mentioned in the proposal are Sun Pharma's multi-vitamin capsule 'Revital', Pfizer's 'Ferradol' and Alkem Pharma's 'A to Z'. These products are currently classified as 'food' and come under the Food Safety Act, which exempts them from stringent rules on pricing and marketing.
An eight-member committee looking into the matter was of the view that the ingredients of these multi-vitamins fall under the category of 'drugs'. It considered parameters like composition of the products, effect of each ingredient on the body, food safety and standard requirements as well as the indications claimed by the firms.
One critical recommendation the committee made was that if a multivitamin product claims that it treats, mitigates or prevents any disease or disorder then it should be classified as 'drug'.
In an email response to ET query on the matter, Sun Pharma said it is still reading the drug controller's recommendations. Pfizer and Alkem could not be reached for comment.
India's nutraceutical market is estimated to be close to $2 billion, with companies having a free hand in determining prices and marketing of such products.
If implemented, the drug controller's proposal could deal a big blow to many companies that are betting big on this segment, according to an industry executive did not wish to be named.
According to figures available from research firm All-India Organisation of Chemists and Druggists Association (AIOCD), the vitamins and minerals segment grew 13% in the last one year to touch .`8,329 crore.
"Vitamins are essential dietary supplementation, just like any other 'food' substance. It is strange that there was only one doctor present in the committee that made this recommendation," said RK Shanghvi, medical and nutraceuticals head of Indian Drugs Manufacturers Association (IDMA), a lobby group of Indian drug makers. "Also, it is sad that there was only one medical professional on the committee that made this recommendation, and that it is not enough to determine the fate of the country's health." Shanghvi also said that such proposals end up being ambiguous, as with the current recommendation, and that even some health drinks can be classified as drugs.
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