First, DCGI may make it mandatory for all such vitamin manufacturers who use any drug as ingredients in their products to take a no-objection certificate from the government. This is likely to become compulsory for manufacturers who use medicinal ingredients for 'non medicinal use', which would include food supplements.
This permission may become mandatory in two cases when drug substances are being imported for non-medicinal use and when drug substances are getting manufactured for non-medicinal uses, clearly targeting vitamins and nutraceuticals which are being marketed as food supplements. Additionally, the drug regulator has decided to form a committee with officials of DCGI, FSSAI and state drug regulators as its members to lay down guidelines for food and pharma companies in the vitamin and neutraceuticals business.
A decision to this effect was taken in a recent meeting of Drug Technical Advisory Board (DTAB). "It was also agreed that the manufacturers intending to manufacture such formulations should be asked to provide the method of analysis or testing protocols for testing of the finished formulations to ensure that these formulations conform to the prescribed standards," an official said.
In the last few months, the food regulator has been issuing multiple directions to state food regulator offices to not issue licences for food supplements, which, under law, can only be issued by the central regulator FSSAI. State food regulators were even instructed to cancel and withdraw licences erroneously granted.
The blurred line between drug and food supplement surfaced in 2009 when the drug price regulator National Pharma Pricing Authority said that pharma firms are marketing drugs as food supplement to escape the price ceiling net.
In a letter to the health ministry, it cited the example of food supplements such as Ranbaxy's Revital and Germany-based Merck KgaA's vitamin E product Evion, which, it said, were earlier getting marketed as drugs. A Bihar High Court order of 2009, however, held that health supplements marketed by various drug companies such as Feradol manufactured by Pfizer, Revital (Ranbaxy), A to Z (Alkem), Beneficial, CSN and DSN capsules (Shreya Life Sciences) need to be marketed as health supplements as the manufacturers have made no therapeutic claims on the label to suggest that can cure.
The Indian nutraceutical market R4,400 crore in 2009 is expected to more than double to R9,500 crore by 2013. Currently, multivitamins marketed as food supplement are just required to label their product 'not for medicinal use'.