289 essential bulk drugs to come under price control

NEW DELHI , 30 JUNE:The government plans to bring medicines made from 289 essential bulk drugs, constituting nearly a third of the country's Rs 58,000-crore drug market, under price control, two people familiar with the development said. At present, about 1,500 medicines that use 74 bulk drugs are sold at prices fixed by the government. In 2003, the Supreme Court (SC) had directed the government to increase the number of bulk drugs under its control. Subsequently, the government had set up a panel of experts to draw up a revised list of National List of Essential Medicines (NLEM) to decide which drugs to bring under price control. Earlier this month, the government announced a revised list of 348 essential bulk drugs (the key chemical in a medicine) and 654 medicines (with specified dosages) made by using these drugs. The revised list added 43 new drugs, including cancer and chronic drugs, while leaving out 47 drugs from the old list of 354 essential bulk drugs prepared in 2003. The department of pharmaceuticals intends to leave out 59 items such as devices and diagnostic kits from the list of 348 essential bulk drugs. This means about 574 formulations with specified dosages made from 289 bulk drugs will be under be price control. In the past, drugmakers have tried to duck price control by tweaking the composition of medicines and there are apprehensions that they may attempt to do so again by launching dosages that differ from the ones specified by government. "The government is aware of this concern and is considering how to plug it," a government official said. The first option is to restrict the Drug Controller General of India from approving dosages other than those specified in the list. If the DCGI route fails, or if other dosages are already in market, the drug price monitoring authority NPPA can bring such dosages under price control using section 10 (b) of the country's Drug Pricing Control Order, 1995 which allows the government to fix prices of medicines outside DPCO in public interest. This list of over 550 medicines will form part of the new pharma policy that will be sent for approval to a group of ministers (GoM) headed by Agriculture minister Sharad Pawar. The new drug policy has been in limbo with the GoM not holding a meeting for about two years. But minister of state for chemicals Srikant Jena told thie reporter last month that once the NLEM is finalised, he will push for an early meeting of the ministers.

Economic Times