Though the Maharashtra FDA has stalled its recent offensive against companies selling nutraceuticals with therapeutic claims for the time being, the history of similar move in Kerala for the past five years reveal the companies were successful in overcoming the proceedings through legal routes and loopholes in rules.
Maharashtra FDA, which had decided to ban nutraceuticals and food supplements with functional claims on their labels since 1st July, dropped the move following a directive from the State Government, two days ago. The decision followed a meeting of industry representatives with Manohar Naik, minister for FDA and special assistance, Maharashtra. FDA Commissioner Ramesh Kumar said the State Government has sent him a letter directing to stall the move. “We are not against manufacturers selling nutraceuticals. Our argument was when companies market nutraceuticals or food supplements with therapeutic claims, they need to take a valid drug license. We are postponing the earlier directive,” said the Commissioner.
Interestingly, a similar initiative of the Kerala drug control administration, the only state to act against nutraceuticals with therapeutic claims since year 2000, has not achieved the desired results so far. The Kerala DCA took about 24 cases in the last five years against such companies. None of the companies are convicted so far and all of them continue to sell their products in the same Rs 600 crore odd Kerala nutraceutical market, thanks to the stay orders secured from courts and the many year-long unresolved legal wrangles. Kerala DCA contends the firms were 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'.
In a significant judgment which justifies the move of the state drug department, a division bench of Kerala High Court in February this year had ruled in the Parry’s Nutraceuticals’s case the court was not a competent authority to determine whether food supplements could be regarded as drugs or not and it is up to the experts to decide it. The complainants should prove their claims before competent forums like the lower courts, if they have grievances on the act of the officials instead of approaching the High Court for securing immediate stay on the ban, the court had said.
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 (39482/03) in Kochi. 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 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, Kerala DCA 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 had withdrawn 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.
Other companies that were booked include Elder Pharma (8266/03), EWA Pharmaceuticals (8270/03), Mayor Organics (9755/04) etc. None of the cases have been settled so far.
Apathy of decisive government authorities and money power of the companies to field high profile lawyers in courts are reasons to circumvent the official actions. “This is despite the recent High Court order empowering the official action to book all manufacturers of nutraceutical products with functional claims,” notes a senior drug control official from Kerala.