The debate about essential-medicine pricing and access in India illustrates the difficulties inherent in establishing policies that serve conflicting public interests in achieving goals such as caring well and ensuring safety for all, while also pursuing financially-sustainable success in scientific innovation and trade. It highlights problems facing those interested in continuing drug and vaccines development and ensuring that, once marketed, such products contribute effectively to improving public health. Modern Pharmaceuticals...

A report by a parliamentary committee has shown that the drug industry regulator, the Drug Controller General of India (DCGI), has been approving, on average, one new drug a month without conducting mandatory clinical trials or seeking expert medical opinion—findings that expose the deep flaws prevalent in India’s drug approval process. The committee has asked the health ministry to withdraw the discretionary powers given to the Central Drugs Standard Control Organization...

That this is the first time a compulsory licence has been granted in India is in itself important. INDIA'S long struggle to ensure access to affordable medicines for its people recently took a positive and interesting turn. In early March, just before he demitted office, Controller General of Patents P.H. Kurian passed an order on an application filed by Natco Pharma, headquartered in Hyderabad, requesting a licence to produce an anti-cancer...

The implementation of Patents Act, as last amended in 2005, raises significant issues of immediate concern to patients across the world. INDIA'S Patents Act has an interesting history. Enacted first in 1911 as the Indian Patents and Designs Act in the colonial era, it primarily addressed the interests of inventors, who did not want their inventions infringed upon by anyone who copied them or adopted the methods used to make them....

India is coming under increasing pressure from the U.S. and the European Union for the strict patentability criteria it applies for medicines. AS was only to be expected, the two landmark decisions made by the Indian patent office in recent times concerning pharmaceutical patent cases have not gone down well with the multinational drug industry. First, there was the rejection in 2006 of the patent application by the Swiss multinational...