Regulating prices of patented drugs marketed in the country is an issue dragging on with no decision forthcoming for the last several years. Although the Indian Patent Act was amended in 2005, the government has been attempting to bring some control on highly expensive patented drugs for more than six years. The government had held numerous meetings and discussions on the issue with various stakeholders but no decision could be taken on this sensitive issue. Meanwhile, MNCs have been applying for patents for a large number of drug products for marketing in the country since 2005. Many of these drugs for treating life threatening diseases are being sold at exorbitant prices as the government has not been able to bring them under price control. The patented drugs are expensive on account of excessive profiteering, loading of huge trade commission and promotional costs. Apart from excessive pricing of some patented drugs, MNCs have been also claiming patent rights for products which are not actually new molecules. These companies have been thus filing applications for patenting different forms of the same drugs, like salt, polymorphs, analogues, crystalline and combinations with other drugs. In other words, the government has been allowing MNCs to make huge profits on products for which no much spending on research was made.

To have a price control on patented drugs, the DoP had constituted an expert panel to suggest a method of reference pricing, price negotiations or differential pricing that could be applied for pricing of patented medicines and medical devices before they are approved for marketing in India. After several years of dilly-dallying on the issue, the panel submitted its report to the DoP in February, 2013. In its report, the committee had recommended a formula on price negotiation of patented drugs, linking it to the per capita income in the country. It also suggested setting up of a committee headed by the chairman of the NPPA to decide the price of patented drugs. After the submission of the report by the panel, the DoP had asked the stakeholders and experts to send their comments and suggestions by March 31 last year to take a final view on the report. As no worthwhile comments came from the stakeholders, the department extended the date to May 7, 2013. As the opinions received are stated to be so diverse, the DoP decided to constitute an inter-ministerial committee to look into the whole issue. When this panel will take a final call on this matter is not clear. These developments only indicate the lack of genuine interest of the government to take a decisive action in this matter. When a competent body like NPPA is already doing a good job in drug price fixation, DoP need not look anywhere to decide the issue of price regulation of patented drugs.