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As many as 2,031 people in India have died because of the clinical drug trials they were subjected to in the past four years. Only 22 of them have been compensated. What's more, no action has been taken so far against any pharma company, ethics committee that oversees clinical trials or contract research organisation that conducts the trials, which have been found guilty of unethical practices. The information became public during the hearing of a Right To Information (RTI) petition by the Central Information Commission on June 29. This is the first time that the office of the Drugs Controller General of India (DCGI) has admitted to not paying compensation for any of the deaths that have occurred so far except in 2010-2011.
According to information provided by DCGI during the hearing, 288 persons died due to clinical drug trials in 2008, 637 in 2009, 668 in 2010 and 438 in 2011.
It was found that compensation was paid only to trial victims who were injured or died in 2010-11, when a committee chaired by Maneka Gandhi, member of Parliament, probed the compensation matter last year. The committee found that around 438 patients had died due to clinical trials in 2010. However, compensation was paid only to 22 patients because pharmaceutical companies claimed that out of 438, only 22 patients had died because of clinical trials and that the other deaths were unrelated and could have occurred due to various other reasons during clinical trials, such as the patients being already terminally ill or suffering side-effects of unrelated cause. A total of Rs 52,33,000 was paid to the 22 trial victims.
“What is the proof that only 22 have died due to clinical trials and the rest of the deaths are unrelated. These pharmaceutical companies play smart and never disclose the reasons,” says Anand Rai, an Indore-based health activist. Rai had filed an RTI with DCGI on February 14 this year, but when no reply was received till 28 February, he filed the first appeal. The answer provided by DCGI was not satisfactory. So, he filed another appeal with the Central Information Commission, which heard the matter on June 29.
During the hearing, it also became apparent that the office of DCGI has no information of any action taken against the ethics committees, pharmaceutical companies and contract research organisations so far. In fact, under the Drugs and Cosmetics Act there is no provision of punishment for sponsor company or ethics committees found guilty of unethical practices.
In the RTI, Rai had also asked for data of serious adverse events of deaths or side-effects that occurred during 2011-2012. But DCGI had no data because it collates such data only after four to six months of the end of a calendar year. The commission asked DCGI to provide this data before July 10 to the applicant and has recommended that the DCGI compile the data on monthly basis. The commission has also asked DCGI to give information regarding sites where trials were conducted between 2008 and 2012, by August 15.
“DCGI has also not been maintaining composite data of serious adverse events that occurred during clinical trials,” says Rai. According to schedule Y of Drugs and Cosmetics Act, any unexpected serious adverse event occurring during a clinical trial should be communicated promptly within 14 calendar days by the sponsor to DCGI.
Rai now plans to take up the matter of compensation with the health ministry.