-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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1144 Deaths During Clinical Drug Trials in 2 Years: Govt
-PTI Clinical drug trials in India led to the death of 1144 people in 2010 and 2011, the government today said. The number of people dying during such trials also include 1106 people whose death could be attributed to diseases like cancer, terminal illness or various unrelated causes which is also known as Serious Adverse Event (SAE) of death, Health and Family Welfare Minister Ghulam Nabi Azad told the Rajya Sabha. "The number...
More »Lack of compensation norms for clinical trials results in exploitation of poor patients-Khomba Singh
-The Economic Times Drug companies paid as little as 50,000 as compensation to families of volunteers who died during clinical trials for new medicines last year, leading to sharp criticism about the paltry sums being handed out and growing clamour among health groups for more stringent guidelines on new drug trials. According to government data accessed by a healthcare activist through an RTI query, Germany's Fresenius Kabi paid 50,000 each to the...
More »CDSCO drafting new norms for financial compensation-Mahim Pratap Singh
-The Hindu In the year 2011, 438 people died due to Serious Adverse Events (SAEs) during medicine trials in India, but pharmaceutical companies provided financial compensation in only 16 such cases. The total amount paid in compensation in all the 16 cases adds up to Rs. 34.88 lakh, with the highest amount being Rs. 5 lakh, and the lowest being Rs. 50,000. This makes 2011 only the second year, for which data are...
More »SC pulls up Centre, MP govt on illegal drug trials
-PTI The Supreme Court on Monday expressed concern over alleged illegal clinical trial of drugs in the country, saying its "unfortunate" that humans were being treated as "guinea pigs". A bench headed by Justice R M Lodha pulled up the Centre and the Madhya Pradesh government for not filing their response on PILs alleging large-scale illegal drug trials in the state and other parts of the country. The bench said, "There has to...
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