India accounts for 1.5 pc of global drug trials on humans

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Amid growing concerns over alarmingly high number of deaths during drug trials in India, new data revealed that of all the clinical trials conducted globally until now, only 1.5 per cent happened in India.

But a lower share in the global drug trial component has not resulted in lesser mortality of human volunteers involved in such trials in India.

On an average, 10 persons have died every week in clinical trials in the country over the past four years.

Between 2008 and 2011, 2,031 deaths were reported during drug trials in India, forcing the government to set up committees for review of the existing clinical trial approval mechanisms.

Mortality rates have remained consistently high despite the public outcry against this trend, with 438 deaths being reported in 2011, preceded by 668 in 2010, 637 in 2009 and 228 in 2008.

The death rate -- more than one person everyday -– is shockingly high when seen in the light of new data the Health Ministry has gathered from the World Health Organisation's international clinical trial database.

WHO data shows that around 1,76,641 clinical trials have been carried out till now throughout the world to test the efficacy of new drugs on humans.

Of these, only 2,770 have taken place in India. It constitutes a mere 1.5 per cent share in total trials held across the world in multiple countries.

Officials of the Health Ministry further say that the component of globally driven trials being held in India is on the decline, contrary to popular perception.

Before March last year, the trials held in India constituted 27.7 per cent of the internationally driven trials involving global drug developers and testers. This share is now down to 20 per cent.

"Clinical Trials Registry of India shows that our share in the globally driven clinical trials is reducing. It has come down from 27.7 per cent to 20 per cent in the last five years. That indicates bulk of clinical trials happening in India are indigenous," Secretary, Health Research V.M. Katoch said.

There is no computive data available with the Health Ministry on mortality of human subjects involved in clinical trials in India vis-à-vis other countries in the world.

The Drug Controller General of India (DCGI), which maintains such data, has information only on deaths that occurred in the country. On 2,031 deaths in drug trials over the last four years, Health Ministry sources say such serious adverse events could occur due to various reasons.

"These could be disease-related deaths like cancer etc or unrelated causes...," the sources said. The government is now awaiting the report of an expert committee constituted to probe irregularities in the functioning of Central Drugs Standard Control Organisation (CDSCO) which grants approvals to companies to hold clinical trials in India.

In its last report, the Parliamentary Standing Committee on Health had alleged an unholy nexus among drug makers, CDSCO officials and experts who grant opinions for use of drugs. The panel had found that CDSCO had approved 33 drugs (out of a randomly selected sample) for use in India without any country-specific clinical trials.

Experts claimed that government data on deaths during clinical trials of drugs in India was 'underestimated'. "In India, we allow the company conducting clinical trial on a drug to appoint its own investigator to assess deaths of subjects involved. There is no independent auditing. Under- reporting is natural," a medical expert, who refused to be named, said. He alleged that the system of DCGI's approval for clinical trial requests is weak.

The Supreme Court had expressed concern over safety of people being used as subjects in clinical trials of drugs. The NHRC is also currently reviewing the matter. It has sought detailed responses from the Central and state governments on regulations in place to approve clinical trials and ensure safety of volunteers involved therein.