National Pharmaceutical Pricing Authority (NPPA) is set to launch action against Merck India Ltd's for classifying its leading vitamin E brand, Evion 400 tablets, into a dietary supplement just to come out of price control, it is learnt. The company obtained the product license with change in the composition from drug authorities of Daman.
While the ceiling price of a strip of 10 tablets of Evion 400 tablets fixed by the NPPA was Rs 14.82 inclusive of all taxes, the company after changing the product from a drug to a dietary supplement has fixed the MRP at Rs 60 for a strip of 10 tablets. Interestingly, the company did not change the brand name and retained its name as Evion 400 and fixed the MRP at Rs 60 against Rs 14.82. Evion 400mg is a leading vitamin E product in the country.
Sources said that the NPPA has already started collecting samples of the product from different parts of the country to initiate appropriate action against the company.
According to information, Evion 400mg previously contained 'vitamin E 400mg' and was manufactured as a drug which was duly notified by NPPA with a ceiling price of Rs 14.82 for a strip of 10 tablets. But the company recently changed its formulations with a composition of vitamin E 400 IU, wheat gram oil 100mg and Omega3 fatty acid 30mg.
Meanwhile, discussions are going on among the experts on whether this product falls under drug or dietary supplement.
Quoting an earlier court order regarding Cadila pharmaceutical v/s state of Karnataka on EC 350 capsule containing vitamin E, Manoj Tongra, drugs control officer, Rajasthan, who is also an expert on legal matters, said that as per the earlier court orders Evion 400mg cannot be a dietary supplement.
Supporting his argument, Tongra said that in the Cadila pharmaceutical v/s state of Karnataka case the Kerala High Court observed that "EC 350 capsule containing vitamin E are not food if considered against the definition of PFA act 1954. Court also observed as the exemption under Schedule K should not be available to these products they are not used by general dietary supplement as per Indian daily dietary requirement it is only 20mg which is mandatory requirement under new food safety bill."
"Anything which falls under the drug cannot be a food and dietary supplement only contains minimum requirement of Indian person on daily basis. This product does not fall under the category of food supplement as well as dietary supplement and this product is a drug as per Kerala High Court with remarks that a combined reading of clause i & ii of section 3(b) would show that this vitamin capsules fall with in the definition of the Drugs and Cosmetics Act 1940," the court noticed.