-The Times of India The new Central Drug Standards Control Organisation (CDSCO) guidelines meant to help calculate compensation in case of clinical trial related injury or death in a fair and equitable manner seem to be loaded against the very people it is meant to help. The guidelines suggest a formula based on the income of the injured or dead person along with age and severity of disease. Such a formula raises...

-The Times of India A once-a-week medicine for diabetics — a disease that affects nearly 63 million Indians — could soon become a reality. Studies on diabetes have seen a global upsurge, with the latest data showing that bio-pharmaceutical research companies across the globe are busy developing 221 innovative new medicines. The drugs, which will help around 347 million patients include new therapies that target key abnormalities of pancreatic cells, increase insulin secretion...

-The Times of India PARIS: The world's most effective vaccine candidate against dengue is all set for trials in India and if all goes to plan, the vaccine will be available globally by 2015. The vaccine will be tested on 120-odd adults in the beginning, the results of which should be available by 2013. Thereafter, a largescale study on children — the main target group — will be undertaken. In an exclusive interview,...

-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...

-Live Mint Incidents at Bhopal and Indore highlight irregularities and ethical violations in some trials In 2004, doctors at the Bhopal Memorial Hospital and Research Centre (BMHRC), established exclusively for treating the victims of the 1984 gas leak, recruited unsuspecting survivors for clinical trials without their knowledge or consent; 14 participants died during the course of the trials. Together with the episode in Indore’s Maharaja Yashwantrao Hospital (that Mint reported on 10...