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....

Confusion sparked by the setting up of a new committee for drug approvals has led to a slide in the number of new medicines getting cleared even as millions of Indians struggle with diabetes and heart failures remain a major killer. The Drug Controller General of India (DCGI) has shed its role as the sole approver of new drugs in the country after a new committee, set up by the health...

The country is clearly shaping its legislation to promote access to medicines by fostering generic production. INDIA'S approach to the revision of its Patents Act in 2005 is a clear example of a country shaping its legislation to promote access to medicines by fostering generic production. Although World Trade Organisation (WTO) rules made it mandatory for India to put in place a patent regime for medicines by 2005, nothing obliges...