The Haryana drugs control department has issued notices to Merck India Ltd, Mumbai and Softech Pharma Pvt Ltd, Daman, the distributors and manufacturers respectively of the controversial vitamin E product Evion 400 tablets, asking the companies to furnish the marketing and manufacturing licenses for the product within 10 days failing which the department will initiate proper action.
In the notice, the drug control department said that it has drawn drug samples from the retail shops in Yamuna Nagar in Haryana. The notice further said that as per the printed cartoon, the said drug has been manufactured by you for sale/distribution. The inner as well as outer cartoon of the said drug bears the composition: each soft gelatine capsule contains: vitamin E 400iu, Wheat Germ Oil 100mg and Omega-3-Fatty acids 30mg.
"It was observed that the label of the drug also does not bear any drug manufacturing license number on it. This is Contravening section 18(C) of the Drugs & Cosmetics Act 1940. In view of details mentioned above, you are required to furnish following informations/documents of U/s 18-B of the Drugs and Cosmetics Act 1940 and Rules 1945 to the undersigned within 10 days," the notice said.
The department asked manufacturers of the Softech Pharma Pvt Ltd, Daman, to furnish self-certified copy of the drugs manufacturing licences as well as approval of the product in question, self-certified copies of the batch manufacturing records of the said drug product, distribution record of this drug, constitution of the firm along with the name/address of all directors responsible persons for day to day conduct of the business of the firm and name and address of technical person responsible for manufacture and analysis of said drugs.
The department asked the marketing company of the drug Merck India Ltd to furnish self-certified copy of the drugs mfg/sale licences as well as approval of the product in question, distribution record of this drug and constitution of the firm along with the name/address of all directors responsible persons for day to day conduct of the business of the firm.
"Your reply must reach the undersigned office within 10 days of the receipt of this notice, failing to which it shall be presumed that you have nothing to say in this matter and ex parte action shall be taken against you," the notice warned.
Evion 400 tablets is a leading vitamin E tablet in the country which courted controversies when the company, Merck India Ltd, classified the product into a dietary supplement reportedly to come out of price control. 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.
According to legal expert Manoj Tongra, who is also a drugs control officer in Rajasthan, the controversial drug cannot be considered a dietary supplement from the legal point of view.