Deaths during clinical trials are increasing in India in the recent years even as the country emerges to be one of the most sought-after destinations of human studies of experimental medicines.
Though no official estimates are available to show the actual number of deaths occurred during clinical studies of new drugs, NGOs and and other human rights groups point out that the numbers indicate that trial subjects deaths are high in among Indian sites compared to other regions.
According to the figures collated with available information collected, as many as 308 persons died in the year 2009 till the month of August, reports said.
The total number of trials registered in India was 158 in 2009, down by 30% compared to 229 in 2008.
While the number of deaths were pegged at 288 in the year 2008. In as compared to a 29% growth in 2008. In comparison with the 2008 figures when the number of trials registered showed a 29% growth rate, the death figures in the 2009 were higher.
132 people died while in clinical studies during the year 2007 even though the exact number of clinical studies registered that period when were not available.
Prior to November 17, 2008 the number of clinical trials actually conducted in government/private hospitals are not available with the Central drugs Standard and Control Organization (CDSCO), as registration of clinical trial was voluntary.
CDSCO has granted permissions to about 2000 clinical studies from the year 2004 till December 2009, reports said quoting official sources.
Indian government has made registration of all clinical trials conducted in the country mandatory from 15th June 2009.
Registration of clinical trials in a publicly accessible registry is very important as it improves the accountability of the stake-holders and also ensures that key information is made available to the public,’’ stated the notification dated 1st of June, 2009.
The Clinical Trials Registry- India (CTRI) has been set up by the ICMR’s National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR).
The idea behind setting up of the Clinical Trials Registry-India (CTRI) is to encourage all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset.
Clinical trial outsourcing market in India is forecasted to grow at a CAGR of over 30% during 2010-2012 to around US$ 600 million by 2012, says new report by RNCOS.
India will become one of the highest growing clinical trial destinations in the world, with this kind of growth, according to the study titled “Booming Clinical Trials Market in India”.
India is becoming a major hub for clinical studies because all the major pharmaceutical and biotech players as well as major CROs are making India their base for conducting global clinical trials.
Finding and recruiting patients – the most crucial part of the clinical research — who can qualify for a clinical trial, is relatively much easier in India as compared to the Western countries.
Increasing prevalence of diseases and low cost of clinical trials are other factors promoting this market. Syngene and Quintiles are right on top in terms of market share in a market which are rather crowd with more than 100 firms working in India in the clinical trial market.