-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...
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Vaccine against dengue to be tested in India -Kounteya Sinha
-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,...
More »Centre planning major changes in rules for clinical trials
-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...
More »The dark underbelly of India’s clinical trials business-Malia Politzer and Vidya Krishnan
-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...
More »Clinical trials: Regulating chaos-Vidya Krishnan and Malia Politzer
-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...
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