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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...

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MP is worst place to be born in country -Sravani Sarkar

-The Hindustan Times The number of infants (below age of one year) succumbing in state has gone down by three for every 1000 children born in the course of last year. Good news, but with a rider. The state continues to retain the infamous tag of being the worst place to be born in the country as it still records the highest infant mortality rate (IMR) among the 29 states and...

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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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Government warns PATH -Aarti Dhar

-The Hindu The government has issued a warning letter to Programme for Appropriate Technology in Health (PATH), asking it to be careful while conducting clinical trials so as to ensure that discrepancies and violations are not repeated in future. The Indian Council of Medical Research (ICMR) had suspended the Phase-V post licensure clinical trial being conducted by PATH, an international non-governmental organisation, in Khamman (Andhra Pradesh) and Vadodara (Gujarat) for Human Papilloma...

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NRHM fails to improve healthcare indicators-Vidya Krishnan

-Live Mint Uttar Pradesh emerges as the state having the worst healthcare indicators in the country Safe child deliveries, the use of contraceptives, and post-natal care for mothers are still largely alien concepts in India’s poorest states, a government survey has found. Uttar Pradesh (UP) emerged as the state having the worst health indicators in the country. The Annual Health Survey (2010-11) to assess the impact of the government’s flagship health programme, the National...

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