In a first of its kind initiative in the country, the Kerala Drug Controller's office has launched an offensive against sale of certain nutraceutical products that fall neither under drugs nor under food supplements category.
The drug control administration in Kerala has identified and seized about half a dozen such products in the past few months, forcing the respective manufacturers to either get a manufacturing license for drugs, or to comply with the norms related to food supplements, said T.P. Gopinathan, Drug Controller of Kerala, in a telephonic conversation with Pharmabiz.com.
He said the identified and action taken nutraceuticals include Cadila's EC 53, Vitamin E & C, Glucosenine Sulphate, an anti-arthritis. Ayurvedic drug manufactured by Troica Pharmaceuticals, Gujarat, and certain products marketed through the Amway network.
The seizure had forced many of these manufacturers to either approach courts or comply with norms related to license for manufacturing drugs or food supplements. Citing an example, the Drug Controller said the action forced Troica Pharmaceuticals to obtain a valid drug license to manufacture its anti-arthritis Ayurvedic drug, which was sold in the state as a food item.
The drug controller's move has significance considering the crowded Ayurvedic drug-manufacturing scenario and market in Kerala, where numerous Ayurvedic drugs are manufactured and marketed in the guise of supplements.
The Kerala Drug Controller noted that in the wake of the Central Health Ministry's move to enforce a new set of laws for nutraceuticals and food items, the offensive against 'neither food nor drug products' will continue, said the DC.
It is to note Pharmabiz.com had reported the Central Health Ministry was seriously considering a revamp of the existing Prevention of Food Adulteration Act of India (PFA Act), and in order to regulate the food and food products sector, was planning to implement a new Food Safety Act (FSA).