The Kerala High Court on Wednesday adjourned its hearing on the cases related to the Kerala Drug Control Department's (DC) offensive against the firms selling certain nutraceutical products, with functional claims on their labels.

At least a dozen cases, including the eight cases took up for hearing on Wednesday, are pending with the High court for the last four years. Kerala is the only state in the country to have initiated crackdown on certain nutraceutical manufacturers alleged to be violating 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'.

The court is learnt to have postponed the hearing for the absence of the counsel or the representative of the Union Government, a respondent in the case. The court has not specified the date for further hearing, sources told Pharmabiz.

According to drug control department sources, more than 24 cases are still pending with the High Court and Lower Courts in the state for the last four years, following the Kerala Drug Control departments decision to book all the firms that violate Rule 18 (C) since 2000. Most of the alleged offenders are still selling their products, thanks to the stay granted by courts against the action of the department.

As per the list of cases pending with the Kerala High court, products like slim kits and a diabetic drug was seized from the distributor of the Chennai- based Franch Technologies (case number 20992/01) by the department in 2001. A stay was given on this, and the DC again booked the firm for carrying misleading advertisements under the Magic Remedies Act (case 21259/2003).

Herbalife, meant for slimming, was seized by the department (case 4273/2002) and its distributors approached the court immediately to get a stay on the ban. J F Herbals was booked for selling a mushroom-based Ginseng product from Korea and is still selling it in the Kerala market (case - 1588/2002). Three products of the multilevel marketing company Amway were seized two years ago (7873 /2002), besides another major seizure during December 2003 in Kochi. Amway still markets its products in the Kerala market, as it managed a stay from the High court fielding high profile lawyers from Delhi.

Alkem Pharmaceuticals was booked for selling Olivol vitamin capsule. The Chennai-based Parry Nutraceutical's flagship product Spirulina came under the seizure list as per the case (6815/2002). Troica Pharmaceuticals, Gujarat, which was selling its anti-arthritis drug Glucosimine capsules as nutraceuticals were seized. The company was later forced to obtain a valid manufacturing license for the product consequent to the legal battle.

A case was filed against Ranbaxy for selling Revital (ginseng plus vitamins), which was Ranbaxy's first brand to be made OTC from the prescription drug category (case 19169/2000). A case was filed against Wockhardt for selling its Winofit vitamin tablets as food supplement (case 6815/2002). Both the cases are still pending.

In the case of Cadila, the DCs office seized EC 53, Vitamin E & C capsules as per the case 3352/2001. Drug control department officials cite that a single bench of the High Court in its verdict had clearly said the product should be regarded as a drug and the officials have powers to follow rules and can decide what should be regarded as drug or food item. Though the company then withdrew the product from the Kerala market, it successfully approached the division bench to obtain a stay order (appeal 1556/2002) on that verdict. Ironically, Cadila sells the product now as a drug.

In the last 20 months, the companies that were booked include Amway (39482/03), Elder Pharma (8266/03), EWA Pharmaceuticals (8270/03), Mayor Organics (9755/04) etc. None of the cases have been settled so far, note sources.