The National Human Rights Commission (NHRC) has sought a detailed report from apex health research body Indian Council of Medical Research (ICMR) and top drug regulator Drugs Controller General of India (DCGI) on clinical trials being conducted in India.
The notices to ICMR and DCGI were sent last week. The commission took suo motu action following media reports highlighting instances of deaths during clinical trials. According to health ministry statistics, 671 persons had died during clinical trials last year. However, the ministry did not link majority of the deaths to the adverse effect of the experimental drugs because many volunteers participating in trials were critical and terminally ill patients.
Officials said they are in the process of responding to the NHRC query. There are rising demands for having proper regulations to monitor and control clinical trials from various sections of the society. The Allahabad High Court is expected to hear a public interest litigation calling for a ban on all clinical trials until laws to govern and regulate trials are in place. Civil society groups alleged that clinical trial monitoring is not mandated under the 70-year-old Drugs and Cosmetics Act 1940, which governs medicine regulation in the country.
“Clinical trials are governed through subordinate rules, and not mandated under the Act. Legally speaking, these regulations can be questioned in the court of law as it does not have legislative backing under the Act,” an official said.
According to a submission by the Union Health Minister before the Parliament, 22 deaths were reported due to serious adverse effects of experimental drugs during the clinical trials in 2010. The minister also informed that in all cases the companies had compensated for the deaths.
The health ministry had asked pharmaceutical companies to compensate clinical trial victims after a probe carried out by the ministry under the instructions of the Parliamentary Committee on Government Assurances headed by Bharatiya Janata Party MP Maneka Gandhi revealed that pharmaceutical majors conducting clinical trials in India have not compensated majority of volunteers who died during the trials. Of the 671 deaths that were reported in 2010, the ministry had evidence of just three cases of compensation.
According to the minister, initially only 25 deaths related to adverse effects of study drugs were reported in 2010 involving nine companies. “Subsequently, it was revealed that in two cases the deaths were reported twice for the same patients. Further, in one case, the ethics committee and the investigator later on clarified that the death was not related to the clinical trial.”
However, civil society groups and medical experts have different views on the ministry claim.
“One needs to dispel this myth that there were only 22 deaths among hundreds of deaths that happened during clinical trials just because companies agreed to pay compensation in 22 cases.” said C M Gulhati, a Delhi-based medical expert.
According to Gulhati, it is normal for companies to understate the quantum of adverse reactions as it would decrease their compensation load. He also said medical practitioners who conduct the trials and the ethics committee who oversee the trials are also interested parties because they are looking for long-term association with pharmaceutical companies. “The regulator should be able to assess the situation. There has to be proper procedures for arbitration in case of trial related deaths. Independent audits are necessary.”
The Drugs and Cosmetics Act calls for life imprisonment and Rs 10 lakh fine (or three times the value of the drug) in case of a death related to consumption of spurious drugs. However, there is no clause in the Act that covers clinical trials, experts said.
According to industry insiders, clinical trials are complicated because it involves not just one person — like the spurious drug manufacturer in the case of spurious drug-related deaths — but several players, including the sponsors of the trial, investigators who conduct the trial, the ethics committees that monitor it and drug regulators who approve the trial.
Y K Gupta, national scientific coordinator of Pharmacovigilance Programme of India, a government initiative to track side effects of approved medicines in the country, said concerns over clinical trials are being addressed in a new bill, which once enacted, will replace the current drug law.
