-The Times of India As many as 436 people died last year due to serious adverse events (SAE) during Clinical Trials. Investigations are now on to ascertain how many of the deaths were caused by drugs administered to the trial subjects. Union health minister Ghulam Nabi Azad said on Friday that deaths could be due to life-threatening diseases such as cancer, heart failure and stroke or side-effects of the drugs or their...

-The Hindu The efforts to win the war against tuberculosis using an efficacious vaccine candidate (MVA85A) in infants aged 4-6 months have returned a disappointing verdict despite showing great promise in pre-Clinical Trials. Though it fulfilled the primary objective of safety and despite inducing modest immune responses, the efficacy of the vaccine was just 17.3 per cent, and hence considered insufficient to protect the infants against TB, notes a paper published...

-PTI National Human Rights Commission (NHRC) today issued notice to Union Health Secretary and Medical Superintendent of Safdarjung Hospital in Delhi on a complaint alleging that more than 8,200 children have died at the institution in the past five years. The panel issued the notices returnable in four weeks on the complaint by RH Bansal alleging that more than 8,200 children up to the age of five years died during the last...

-The Economic Times Pharma companies sponsoring Clinical Trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban. The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of Clinical Trials. A senior government official said...

-Live Mint Developments a part of reforms initiated after apex court’s intervention to amend Drugs and Cosmetics Act The health ministry has tightened the norms for Clinical Trials by making it mandatory for companies to compensate patients who may suffer injury or death while participating in the trials even if they have not been caused by the drugs being tested.   So far, the compensation has been restricted only to cases where the...