-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...
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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 »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 »Public health crisis-R Ramachandran
The goal of universal health care requires an overhaul of the public health system, medical education and regulatory mechanisms. At long last, public health is on the agenda of the country’s policy makers. The Prime Minister’s Republic Day speech mentioned that the Twelfth Plan would focus on health just as the Eleventh Plan had focussed on education. But the manner in which the education sector has been messed with does not...
More »Hit by red tape, clinical trial companies eye South-East Asia for expansion-Divya Rajagopal
-The Economic Times Pushed to the wall by an overly cautious drug regulator and an alarmist Indian government, clinical trial companies are looking at South East Asian countries to expand their business and escape the red tape of Indian authorities. Clinical research companies (CROs), that were aspiring to become billion- dollar companies by 2010, had to rework their plans after a Parliamentary Standing Committee report questioned the allegedly unfair and unethical trials...
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