Health Min asks state regulators to keep tab on companies trying to dodge price ceiling by changing ingredients

Even as the new draft policy prepared by the Department of Pharmaceuticals (DoP) suggested price control of formulations to check the companies from circumventing the practice of dodging price control mechanism, the health ministry has asked the state regulators to report cases of companies changing ingredients while retaining the popular brands. Sources in the ministry said no fresh case had been reported yet but all state drug controllers have been asked not to grant licences in such cases. Apart from this, the ministry has also asked them to implement sternly the provisions of the Drugs and Cosmetics (amendment ) Act, 2008 that enhanced penal provisions against tampering with the quality of drugs. Because of companies engaging into the practices of changing the ingredients under the same brand to evade price ceiling, the draft policy has suggested price control over formulations instead of bulk drugs which was practised so far. “The experience in recent years has been that circumventing price controls is not difficult through non-standard combinations, dosage strengths, and other such mechanisms. In addition, there is a tendency for prescriptions to move away from controlled drugs to non-controlled drugs in the same therapeutic class. The consequence on the quality of treatment may get affected and additionally lead to the consumers buying higher priced products,” according to the draft policy. Meanwhile, sources in the ministry said that the Food Safety and Standards Authority (FSSAI) was having consultations with the National Pharmaceutical Pricing Authority (NPPA) to frame rules to check this practice of changing ingredients to make formulations into food and nutrition supplements. 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 (DCGI) to take action by bringing in necessary amendment to the Drugs and Cosmetics Rules to stop companies from replacing drug ingredients with food ingredients.