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US FDA may start on-site inpections of drug testing centers on humans in India: Report

Monday, July 5, 2010, 19:11 This news item was posted in Clinical Trials category and has 0 Comments so far.

Inspectors from the US Food and Drug Administration (US FDA) may soon start inspections in Indian clinical trial sites to ensure compliance of regulatory and ethical practices to be followed by organisations that conduct drug testing in humans.

The Department of Health and Human Services in a recent report found serious deficits in overseeing the clinical studies conducted overseas which the drug giants heavily rely upon for submissions for clinical trials data for obtaining regulatory approval for med drugs and devices.

80 per cent of new drugs and biologics applications approved by the FDA in fiscal year 2008 contained clinical trial data from foreign sites. However, US FDA has inspected only very small number — 0.7% of clinical trial sites conducting studies on investigational drugs by US companies during this period.

While, US FDA inspectors visited 2% clinical trial sites in the United States, revealed a report by the HHS’s Office of Inspector General.

Following the findings on the deficits in inspection, the US health department has alerted US FDA on the necessity for increased vigilance and monitoring of clinical trial sites abroad, especially in the developing nations, reports said.

US FDA has set up offices in a developing countries and planning to establish more such inspection centres in various countries which have a stake in drug exports to US or serving clinical trial destinations for drugs seeking approval for US market.

In India, two representative offices for on-site inspections have been already set up in the cities of Delhi and Mumbai by US FDA.
India has become one of the much sought-after centres for drug testing and hundred of new drugs and medical devices are being studied on Indian patient population.

According to official figures, the Central drugs Standard and Control Organization (CDSCO) granted permissions to about 2000 clinical studies to be conducted in India from the year 2004 till December 2009.

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.

Indian government has made registration of all clinical trials conducted in the country mandatory from 15th June 2009.

Clinical trial outsourcing market in India is forecast 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.

Western Europe accounts for 58 per cent of subjects enrolled at foreign sites and 60 per cent of foreign sites for the US FDA filings.

Central and South America also enrolled a significant number of subjects – around 26 per cent of all subjects at foreign sites – but the region accounted for only 7 per cent of total foreign sites.

Peru, had the fourth-largest subject enrolment, yet US FDA inspected no trials there. There are also several other countries with a large number of subject enrolments that were not inspected by US FDA for marketing applications approved in FY 2008. These include: Colombia, Chile, Panama, Venezuela, Nicaragua, the Dominican Republic, Denmark, Norway and Poland, according to the HHS report based on the figures of 2008.

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