Of the 370 deaths, 222 (60%) cases have been examined so far by a regulatory panel on clinical trials. Of these, only 21 were eligible for compensation as the the drug under trial was found to have caused the deaths, the official said.
Medical experts, however, say there is lack of clarity on the norms on which eligibility for compensation is decided. It is largely subjective, they point out, and the basic data comes from the very investigators who are involved in conducting the trial. Hence, it is not only possible for them to influence or manipulate data, there is hardly any wherewithal with the regulatory agencies to check its authenticity.
“The investigator who reports adverse impacts of a drug under trial has conflict of interest because he is paid by the pharmaceutical company conducting the trial,” says Dr CM Gulati, editor of Monthly Index of Medical Specialities and an advocate of public health.
After a nudge by the Supreme Court, the government and drug controller general of India (DCGI), which monitors the quality of medicines as well as their testing, recently notified detailed guidelines for conducting clinical trials and reporting of data related to deaths. The regulator has also worked out a mechanism for paying compensation to the families of those who die during these trials.
Drug companies target rural areas
As per the new rule put in place in January 2013, an independent expert committee examines the reported adverse events and makes recommendations to the licensing authority or DCGI, which will ultimately take a call on the quantum of compensation.
However, health experts say the biggest draw for drug makers is the lax regulatory environment. “These expert committees evaluating registered deaths are in metros whereas companies pick up remote villages and small towns for conducting clinical trials,” says a medical practitioner, pointing out that though companies insist they follow global best practices, participants in rural areas are often barely aware of the possible consequences of the trial.
Health experts say the biggest draw for drug makers is the lax regulatory environment.
The DCGI and other regulatory authorities claim there are adequate procedures in place to safeguard public interest. Of late, the regulator has started approving fresh trials.
The industry was faced with a slowdown since 2012 after repeated directives from the apex court for safety procedures for patients participating in the trials. The clinical trial industry in India is pegged at over Rs 3,500 crore and is growing at 10-12% annually.