India

Drug trial compensation increased though still not enough, say experts

By RJ Whitehead

- Last updated on GMT

Drug trial compensation increased though still not enough, say experts
While India plans to increase compensation payments to volunteers who suffer disability from clinical trials, some experts have criticised the new regime for not going far enough.

Authorities aim to increase the upper limit of compensation to Rs66 lakh (US$104,000) for permanent disability that is proved to be the result of taking part in live experiments at the late stages of research—which equates to 90% of what can be paid out of a clinical participant dies.

In a landmark draft bill released by the Central Drugs Standard Control Organisation (CDSCO), an amended law, if passed, would provide for new rules that require research companies to compensate individuals or their families if a trial causes injury or death.

The increase over sums paid through the previous formula, which was in practice between 2005 and 2012, is significant. However, this is still not enough, according to regulatory expert, CM Gulhati, quoted in the Economic Times​.

Going by the official definition, a patient who has lost vision in one eye will be deemed to suffer from 40% disability and entitled to 36% of compensation prescribed in case of death. But if he happens to be a pilot, he will lose his job​,” Gulhati told the paper.

For any disability that stems from clinical trials, all payments would range between US$2,800 and US$104,000, if the draft law is passed.

Whether the injury or death of a person in the course of a clinical trial, has been caused due to such clinical trial or not, shall be determined by such authority and in such manner as may be prescribed​,” the proposed bill says.

The move makes Indian trial regulations among the most stringent in the world, with the wording suggesting that awards would be given in compensation regardless of whether the trial sponsor is at fault for the injury.

The compensation formula was worked out in May last year and depends on the subject’s age and risk factors for disease, alongside a base amount of compensation of around US$13,000.

It was released after an order from the Supreme Court criticised CDSCO for unmanageable trial regulations that resulted in a number of Indian deaths.

However, the sum involved does not take into account the salary of the the subject at the time of the disability, meaning that compensation for lack of future earnings is not considered in the event of a long period of hospitalisation. 

Gulhati also questioned why actuaries, who typically determine compensation, were not included on the four-member panel that decided on the methodology.

Campaign groups have questioned the use of Indian subjects in trials by multinational companies, often suggesting that such businesses see nationals as a cheap resource.

Since February 2013, 370 people have died in clinical trials in India, with sponsors having paid compensation in just 21 cases, according to the DNA ​newspaper.

Contact research organisations, clinical research associates and ethics committees may also have to register as part of a raft of new trial regulations released in July that also ensure trials are properly designed and that investigators work on a maximum of three trials at one time.

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