Drugs with composition change need fresh approval

NEW DELHI: Drugmakers changing the composition of existing formulations to escape price caps will now have to come to the Centre for fresh approvals. In a move aimed at keeping a check on companies, which replace price-controlled ingredients with ones outside price control, the Centre has directed state drug regulators not to allow them to sell such drugs with their old brand names.  Instead, such drugs will be treated as new ones and the companies will have to go through the Centre’s scrutiny before it gets a fresh approval, a government official said. The move is significant as companies are now likely to think twice before they make any change in the existing composition and approach the Centre for a fresh approval. This would also mean that companies will have to subscribe to a new brand name. The decision comes in the wake of the National Pharmaceutical Pricing Authority (NPPA) seeking action from the Drug Controller General of India (DCGI) against companies that dodge price control by tweaking ingredients of medicines and then misguide consumers by retaining the original brand name. “We have been receiving cases from NPPA for sometime now where companies have altered the composition and retained the brand names. This amounts to misleading consumers. We have, therefore, asked all state drug regulators to treat such drugs as new drugs and not give approvals to sell under the same brand name,” DCGI Dr Surinder Singh told ET. According to Dr Singh, even though NPPA referred such cases to DCGI, it could not do much till now as companies seek approvals or licences to sell from the state drug regulators. “Now, we have classified such cases as new drugs and hence the companies will have to come to the Centre to get an approval where we can evaluate the efficacy of the ingredients,” he said. While NPPA had come across such cases during its survey, it could not do much as the medicines no longer remain under the price control ambit of the government. It has been referring such cases to DCGI. It has also written to DCGI to take appropriate actions against such violations. “Our mandate does not include keeping a check on such violations. All we can do is to bring them to the notice of DCGI,” NPPA chairman Dr AK Banerjee said.