Health Ministry, which is still looking at the long-pending issue of pharmaceutical companies changing ingredients to push the drugs as dietary supplements, will bring it to the inter-ministerial panel preparing the new Drug Price Control Order (DPCO).

If the matter is taken care by the panel, the new DPCO which is expected in a couple of months in line with the new pharmaceutical policy, will have sufficient provisions to check the companies from dodging the price control by changing ingredients and strengths of formulations, it is learnt.

National Pharmaceutical Pricing Authority (NPPA) had raised the issue with the Health Ministry a couple of years back. The agency found that some manufactures were shifting scheduled drugs to the category of Food & Nutrition Supplement manufactured under Prevention of Food Adulteration Act, 1954 (PFA Act) and selling them as vitamin tablets/capsules/food supplements. A formal reference was made by NPPA to the Ministry of Health & Family Welfare for appropriate action to curtail such practices.

Following this, the Health Secretary had held a meeting in May last year and decided that the CDSCO would collect material from the prescriptions and the literature accompanying the food supplements carried by these companies and warn the companies. The drug authorities also took some steps in this regard.

Besides, it was also decided that the suitable amendments would be made to the definition of “drugs” under Section 3(b) (i) of the Drugs & Cosmetics Act 1940 and Schedule ‘K’ of the Drugs & Cosmetics Rules.

With the new policy covering more drugs under price control, it is pointed out the new DPCO should have sufficient provisions to stop companies from adopting this tactic, though the NPPA has recently tightened the norms to make it mandatory for the companies to get prior approval before changing the ingredients or strengths of formulations.

The Parliamentary panel attached to the Ministry of Chemicals also had raised this matter recently in its report and recommended stern action against the erring companies. “While expressing their concern over such strategy adopted by the pharma companies, the Committee recommend that the Department should expeditiously identify the concerned pharma companies and take up the issue strongly with the Ministry of Health and Family Welfare,” the panel said.

“The Committee also desire that NPPA should not hesitate to invoke the relevant provisions of the DPCO, 1995 to curb such alleged malpractices by the drug companies. Thus, the circumventing of the price control mechanism by some manufacturers by shifting schedule drugs to the category of Food and Nutrition Supplement manufacture under Prevention of Food Adulteration Act 1954 should also be monitored by the NPPA. In this regard, NPPA cannot shirk away from its responsibility and leave the matter at the behest of the Ministry of Health and Family Welfare,” the report said.