Taking a serious view of the alleged instances of drug manufacturers circumventing the provisions of the DPCO, the Chemicals and Fertilisers Ministry has directed the National Pharmaceutical Pricing Authority (NPPA) to take up the matter with the union health ministry to ensure that such practices do not continue.

In the wake of the recent doping instances by the sports persons, Minister of State for Chemicals and Fertilizers Srikant Kumar Jena reviewed the situation concerning the composition of various multivitamin drugs etc, being sold in the market. He reviewed the control of NPPA over various multi-vitamins and mineral tablets/capsules etc being marketed in the country.

It was pointed out that most of these multi-vitamins are being sold as food supplements licensed under Prevention of Food Adulteration Act, 1954 and Jena directed NPPA to look into this issue in detail and take up the matter with Ministry of Health and Family Welfare to ensure that no new license under PFA are issued to such manufacturers for food supplements containing multi-vitamin etc, till Food Safety Rules are finalized and adequate measures are put in place to prevent misuse of the Act, if any.

The NPPA has a mandate to fix/revise the prices of scheduled bulk drugs & its formulation and have been fixing the prices of various scheduled drugs which includes multivitamins/minerals. As per notifications issued by NPPA, any drug containing any of schedule formulation, even if it contains any other non-scheduled drugs, is covered under mandatory price control. From time to time, NPPA has issued price notification notifying ceiling and its equivalent MRP (inclusive of all taxes) in respect of multivitamins and mineral tablets/capsule containing scheduled formulations namely Vitamin A Acetate, Vitamin E, Thiamine Mononitrate, Riboflavin, Ascorbic Acid, and Calcium Panthothenat, according to an official release.

“Instances have come to the notice of NPPA that some drug manufacturers are marketing their vitamins and minerals formulations containing scheduled drugs such as Vitamin B1, B2, C, E, A with other non-scheduled vitamins and minerals such as Folic Acid, Vitamin B12, Vitamin B6, Niacin amide as dietary items/food supplement. They are not following the ceiling price fixed by NPPA from time to time. This is done by shifting production from license issued under Drugs and Cosmetic Act 1940 to the license issued under Prevention of Food Adulteration Act, 1954 (PFA, Act 1954). The license under PFA Act 1954 is obtained by them from the concerned chief medical officers of that area,” it said.

Drug manufacturers are violating the price notified by NPPA and selling such products at a very exorbitant price and thus getting unethically enriched at the cost of common man by marketing such products as food/dietary supplement. In reply to show cause notices, it is contended by the manufacturers that they are out of the purview of DPCO 95, accordingly the price notification of NPPA would not be applicable to them.

The above practice followed by the companies has been brought to the notice of Ministry of Health and Family Welfare from time to time wherein they were requested to examine the matter and take appropriate action to prevent the same. The Ministry of Health and Family Welfare had earlier informed “Section 22 of the Food Safety and Standards Act, 2006 covers nutraceuticals, functional foods, food for special dietary uses, health supplements and similar products which do not include a drug defined in clause (b) and ayurvedic, sidha and unani drugs as defined in clause (a) & (h) of section 3 of the Drugs cosmetics Act. 1940 (23 of 1940) and rules made there under. The rules and regulation to regulate such products as specified under section 22 of the Food Safety and Standards Act are being formulated by the Food Authority.” Such rules are yet to be formulated by the Food Safety and Standard Authority of India (FSSAI).

“Since this practice has became a serious menace, NPPA has once again requested the Health Ministry to advise the concerned agencies/authorities/persons not to issue any license under PFA Act 1954 to such manufacturers, pending enactment of Food Safety Rules. It has also been suggested that the Drug licensing authorities be advised to verify the premises of the Drugs manufacturers if food/dietary supplements are being manufactured illegally in the premises which are licensed for manufacture of drugs and take stringent action against the defaulters, as, under schedule M of the Drugs and Cosmetics Rules, the manufacturing premises shall be used exclusively for production of drugs and no other manufacturing activity shall be undertaken therein,” the release said.