After keeping the issue 'in process' for over two years, the Health Ministry has now asked the Food Safety and Standards Authority (FSSAI) to frame rules, in consultation with the National Pharmaceutical Pricing Authority (NPPA), to check the practice of pharma companies changing ingredients of drugs to dodge price control mechanism.
The FSSAI will consult the NPPA to tackle the issue by framing rules under Section 22 of the Food Safety and Standards Act. The task was given to FSSAI as the drug companies changed some drug ingredients to convert the formulations into food and nutrition supplements in a bid to circumvent the price control order.
The NPPA had come across such cases a couple of years back and reported the matter to the Health Ministry as it violated the Prevention of Food Adulteration Act too. Besides, it also urged the Drug Controller General of India to take action by bringing in necessary amendment to the Drugs and Cosmetics Rules to stop companies from replacing drug ingredients with food ingredients.
The NPPA had cited the cases of Evion 400mg of Merck, Revital of Ranbaxy, Recharge Plus of Trikio, Soft Z gold of Indchem, among the few formulations in which the ingredients were changed to get out of price control. NPPA also took legal advice from the Department of Legal Affairs on the issue related to multivitamin capsules and tablets being sold at inflated price as food supplements to circumvent DPCO, 1995, sources said.
“As the matter relating to composition of drugs under Drugs and Cosmetics Act as well as adulteration of drugs is under DCGI, the NPPA has requested the Health Ministry to examine the matter and take appropriate action to prevent the same. Based on the consultation with the Law Department, now the matter has been entrusted with the FSSAI as the companies marketed them as food supplements by changing the ingredients. FSSAI will frame necessary rules in consultation with the NPPA,” a senior official said.
The issue, which has been held up for long now, also was cited by the Parliamentary Standing Committee on Chemicals which asked the Pharma Department to co-ordinate with the health ministry to check such attempts by the pharma companies.
“The Committee notes that some companies have allegedly shifted the production of medicines that are under price control to food and nutrition supplements manufactured under Prevention of Food Adulteration Act, 1954 in order to circumvent the control mechanism. The Committee recommends that the pharma department should take necessary steps in co-ordination with the Ministry of Health and Family Welfare to curb such alleged malpractices of drug companies. The Committee would like to be apprised of the action taken in the matter. The Committee desire that the list of companies indulging in such malpractices and action taken against them should be submitted to the Committee,” an earlier report by the panel said.