Amway India, part of the multi-level marketing major Amway, has filed a petition in the Mumbai High Court challenging the Maharashtra Food and Drug Administration's (FDA) action demanding the company to take valid drug manufacturing licenses for selling some of its products in the state.

The court has admitted the petition and its hearing have been scheduled for the last week of February. Two weeks ago, the Maharashtra FDA had seized Amway products worth Rs 2 lakh under section 3 (B) and section 18 (C) of Drugs and Cosmetics Act. The seized products included packs of Nutralite - a multivitamin and mineral supplement, Nutrilite daily, folic acid tablets for anaemia and few other products.

As reported earlier, the state FDA has launched an offensive against companies marketing nutraceuticals or food supplements with therapeutic claims.

Speaking to Pharmabiz, Shankar Parmeshwar, director, Amway India said that the company had decided to challenge the FDA action in the court, since Amway did not make any medicinal claim for its products.

"We manufacture our products as per the Dietary Supplements Act and market them as dietary supplements. We have food license. Our products make no drug claim. In fact, our products have caution- 'Not for medicinal use'. If the government introduces any such law in future that demands us to take drug license for our products, we will definitely get it. But at present there is no such law that says that our products require a drug license," he elaborated.

Parmeshwar noted that the Maharashtra FDA had issued a similar order in June 2005, banning nutraceuticals and food supplements with functional claims. However, the order was frozen following the intervention of Manohar Naik, Minister for FDA and special assistance, Maharashtra and an ensuing directive from the State Government.

As reported earlier in Pharmabiz, Amway is fighting a similar case in the Kerala High Court against the Kerala drug control administration. Several neutraceutical cases are still pending with the High Courts and Lower Courts in Kerala for the last five years, following the Kerala Drug Control departments decision to book the firms that violate Rule 18 (C) of the Drugs and Cosmetics Act, by which the firms require a valid manufacturing and marketing license to sell products that qualify to be called as a 'drug'. Interestingly, none of the companies have been convicted so far and most of the companies are still selling the products freely in the state, thanks to the stay orders from courts.