The Drug Control department of Kerala may soon restart action against companies selling products as nutraceuticals, which are neither food nor drug, as an appeal of Ahmedabad based Cadila Pharmaceuticals has been dismissed by the division bench of High Court a few days ago.

The state DC's initiative against nutraceutical manufacturers for allegedly violating Rule 18 (C) of the Drugs & Cosmetics Act, by which the firms require a valid manufacturing and marketing license to sell products that qualify to be called as a 'drug', was in a stalemate due to various stay orders obtained by the drug companies from the court. The administration has now decided to act at the first seller point exemplifying High Court's dismissal of a writ appeal (appeal 1556/2002) filed by the Cadila for its EC 53, Vitamin E & C capsules.

The company was filing an appeal in the division bench following a verdict, by the single bench of High Court citing the product should be regarded as a drug. The drug officials have powers to follow rules and can decide what should be regarded as drug or food, sources said.

The division bench comprising Justice KS Radhakrishnan and Justice M Sasidharan Nambiar issued a verdict dismissing the appeal on March 13, 2006, as the plaintiff was not pressing the issue any more. Interestingly, Cadila sells the product now as a drug.

Pointing out the case as an example, the state drug control administration has commenced issuing verbal intimations to the companies and is planning to seize the products within a short period, officials said.

As Pharmabiz reported earlier, more than 20 cases related to the Kerala Drug Control Administration's (DC) offensive against the firms selling certain nutraceutical products, with functional claims on their labels, are still pending with the High Court and Lower Courts in the state for the last six years. Many of the companies have obtained stay orders against the DC's action.

Products like slim kits and a diabetic drug from the Chennai- based Franch Technologies (case number 20992/01), the popular Herbalife, meant for slimming (case 4273/2002), a mushroom-based Ginseng product from Korea, distributed by J F Herbals (case - 1588/2002) and three products of the multilevel marketing company Amway (case - 7873 /2002) are some of the cases under consideration of High Court. Many of these products are available in the Kerala market as the companies obtained stay order soon after seizure of products. The companies that were booked within the last few years include Amway (39482/03), Elder Pharma (8266/03), EWA Pharmaceuticals (8270/03), Mayor Organics (9755/04) etc.