While the Central Government's proposed Health Food Supplements Bill having provisions to bring nutraceuticals and dietary supplements under specific laws is still in the cold storage, the Kerala drug control department's offensive against the firms selling certain products which are neither food nor drug have drawn flak from the industry.

Industry sources note that the manufacturers and their marketing agencies are allowed to sell dietary supplements as OTC items in all the other states. The products are manufactured in accordance with the laws and only with the consent of the drug control officials in their respective states. Since they had not objected to the manufacturing and marketing of these products, the unilateral initiative of Kerala is not justifiable. The move has severally affected numerous manufacturers, feel industry circles.

"Firms spend lots of money on research, development and manufacturing of their products. This is a good example of how the industry is being taken for a ride by the officials by interpreting rules. In cases like this, the small-scale manufacturers are the most affected, since they are not financially sound to fight their case in the court unlike large scale firms that can afford to do that," says T S Jaishankar, chairman of the Confederation of Indian Pharmaceutical Industries (CIPI).

"I think the prime responsibility of the drug control mechanism is to safeguard the health of our public and there is no harm in such actions. We are not banning any products. What we ask is to sell drugs as drugs and food items as food only. Now many MLM companies are also selling drugs claiming them as food supplements. The matter is still before various courts and legal proceedings have taken many years," said T P Gopinathan, drug controller, Kerala.

Sources pointed out that the Kerala DC has registered numerous cases in the last four years against various firms, including majors like Ranbaxy, Cadilla etc. The firms were booked for violating Rule 18 (C) of the Drugs and Cosmetics Act, by which the firms require a valid manufacturing and marketing license to sell these 'drugs' in Kerala. However, most of the manufacturers have managed get stay orders against the decision and continue to sell their product in the state.

According to the cases filed in the Kerala High Court, products like slim kits and a diabetic drug was seized from the distributor of Chennai based Franch Technologies (case number 20992/01). 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). The popular Herbalife, meant for slimming, was seized by the DC (case 4273/2002) and its distributors approached the court 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. Amway still markets its products in the Kerala market.

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 later obtained 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).

In the case of Cadilla, 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, Cadilla sells the product now as a drug, note sources.

In the last 18 months, the companies that were booked include Amway (39482/03), Elder Pharma (8266/03), EWA Pharmaceuticals (8270/03), Mayor Organics (9755/04) etc., said sources.