PRICING PATENTED DRUG

 Wednesday, September 12, 2012, 08:00 Hrs[IST] A fundamental flaw in the current drug pricing policy in India is the absence ofregulation on high priced patented drugs. After the introduction of product patent regime in 2005, multinational drug companies have been importing large number of patented products for marketing in the domestic market. These drugs are being sold at exorbitant prices as the National Pharmaceutical Pricing Authority did not try to bring them under price control as yet. Most of the patented drugs are highly expensive on account of excessive profiteering, loading of huge trade commission and promotional costs. The need to have some kind of price control on patented drugs was felt soon after the new patent law was notified and when MNCs started introducing patented drugs in the Indian market. But the matter dragged on for years. An expert panel was set up by the Department of Pharmaceuticals for the purpose six years ago but no decision was arrived at so far. Even the draft proposal for new drug pricing policy brought out by the government last year leaves out the issue of pricing of patented drugs. Now, NPPA has approached the Department of Pharmaceuticals seeking an amendment of DPCO,1995 to bring pricing of all the imported drugs under its scrutiny and price control. How long this process will take is something to be watched.Apart from excessive pricing of patented drugs, MNCs have been also claiming patent rights for products which are not actually new molecules since 2005. These companieshave been filing applications for patenting different forms of the same drugs, like salt, polymorphs, analogues, crystalline and combinations with other drugs. By doing this, they just tried to corner a broader spectrum of protection for commercially significant forms of the same compound. The patent offices in the country have thus granted patents to dozens of products which do not merit patent protection at all. Filing of multiple patent applications for various forms of the same drug is possible within the framework of the amended Patent Act. A study conducted by Indian Pharmaceutical Alliance in 2009 found that at least 86 cases of patents granted for pharmaceutical products were just minor variations of existing molecules. And between 2005 and 2010, about 13,000 patents have been already issued to various chemicals and pharmaceuticals by Indian patent offices. Obtaining a patent implies an exclusive marketing right for the product for 20 years and if MNCs fix any price for such products without considering socio economic reality of the country that needs to be stopped in the public interest. Granting of patent right for a new drug product and charging a high price for it may be justifiable in case of a non essential drug but that cannot be allowed in case of a life saving drug in India.