-The Hindu Drugs Controller must be told of adverse events within 24 hours Under sharp criticism for inadequate monitoring of clinical trials in the country, the Union Government is contemplating major changes in the Drugs & Cosmetics Act, 1940, and its Rules. These would make it mandatory for the Investigator to report all serious adverse events, including deaths, to the Drugs Controller General of India (DGCI), as well as the sponsor and...

-The Hindu The new Bill should pitch for free care to mental health patients in public hospitals. Persons with mental illness have long been subjected to cruelty, neglect, ridicule and stigma. In the last half-century, medical science has made significant strides in finding some cures and palliatives for afflictions of the mind – of emotion, mood, thinking and behaviour. Parallel to this is the evolution in our ethical frameworks: of human rights,...

-Live Mint The first in a two-part series examining the opaque world of clinical trials in India  A hospital in Indore has been able to get away with unethical medical trials in which 32 people have died over five years, according to the state government. This despite several investigations, a state government ban and Supreme Court strictures—a classic example of the lawless nature of the clinical trial business in India.   Lata Mehra, who...

-Outlook Indian MPs would soon float a forum to advocate elimination of stigma and discrimination against persons affected by leprosy. "Next parliament session, we will float a forum to end leprosy and advocate the rights of persons affected by the disease," Trinamool Congress MP Dinesh Trivedi said at an international symposium on leprosy and human rights in Asia. Also supporting the cause were Minister of State for Human Resource Development and Lok Sabha...

-The Economic Times MUMBAI: In a victory to generic drugmakers, the Intellectual Property Appellate Board (IPAB) of Chennai has dismissed German pharma major Bayer's plea, seeking a stay on the Compulsory Licence issued to Hyderabad-based drugmaker Natco. The Compulsory Licence (CL) issued by the Controller of Patents in March this year allowed Natco to make and sell a generic version of Nexavar - used for treating liver and kidney cancer - at...