-The Telegraph New Delhi: The Supreme Court today asked the Centre to allow clinical trials on new pharmaceutical compounds only after ensuring to the extent possible that their potential benefits outweigh their risks and they are needed in India. A bench of Justices R.M. Lodha and Kurien Joseph, responding to a public interest petition by a non-government organisation called Swasthya Adhikar Manch, also told the Centre to ensure that the candidate compounds...
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Pharma companies to compensate for clinical trial death, injury
-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...
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 »10 die per week in drug trials in India
-The Indian Express The government will be analysing mortality figures during drug trials in India following WHO data showing that 2,031 people died between 2008 and 2011 in such trials in the country. That amounts to about 10 people per week, or more than one person a day. At the same time, the data shows that only 1.5 per cent of clinical trials held across the world so far (2,770 of 1,76,641)...
More »Shamnad Basheer, Intellectual Property Law Professor at NUJS interviewed by V Venkatesan
PROFESSOR Shamnad Basheer joined the National University of Juridical Sciences (NUJS), Kolkata, in November 2008 as the first Ministry of Human Resource Development Chaired Professor in Intellectual Property Law. Before this, he was Frank H. Marks Visiting Associate Professor of Intellectual Property Law at the George Washington University law school and a research associate at the Oxford Intellectual Property Research Centre (OIPRC). He is the founder of several initiatives, including...
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