Brinda Karat, former MP and Polit Bureau member of the Communist Party of India (Marxist) has asked the Centre to take action against the doctors allegedly involved in the clinical trials on patients in Indore without following the proper guidelines.
Ms Karat presented a memorandum to the DGCI Director General V.G.Somani, in which she said the Indore trials were symbolic of much that was wrong in the system of clinical trials in the country, which considers human subjects as guinea pigs and caters to the dominant interests of powerful pharmaceutical companies.
“It is incumbent on the DCGI office to act urgently by instituting a time bound inquiry into the Indore trials and the violations for which there was ample prima facie evidence and the inquiry must include the Ethics Committee members who acquiesced in the violations,’’ the memorandum said. She also suggested blacklisting of the companies sponsoring the trials where such violations had occurred and even recommend cancellation of licenses of doctors involved
“It is only stringent action which will help to eliminate the gross violations of the law in the conduct of clinical trials of which the Indore trials are a classic example,’’ Ms Karat said while drawing the attention towards the lack of informed consent from the subjects of the trials the vulnerability of the subjects as almost all were from poor sections of the population and moreover dependent on the doctor whose treatment he/she was under. Yet shockingly, even a year after the flagrant violations of the trial were exposed and the facts made public, the DCGI has failed to act against those involved, she added.
Further she pointed out that the Madhya Pradesh government had set up an inquiry that found some of the doctors guilty of not reporting the trials, and not keeping records for which they have been fined a small amount. In another State government enquiry conducted by the Economic Offences Wing, it was found that doctors conducting the trial in Government hospitals were paid per subject recruited and the payments ran into lakhs of rupees and even crores in some cases. While these are clear violations for which the licenses of the doctors should have been cancelled the State government took no action.
However the inquiry report had also specifically recommended that as far as the violations of the Drugs and Cosmetics Act are concerned and the violations of the Indian Council for Medical Research or Medical Council of India guidelines, there should be further investigations by the DCGI and the ICMR
Apart from the doctors involved, under the law it is the sponsors of the trial, the pharma companies who are to be held responsible. Unfortunately it is the power of these powerful lobbies which prevail and the guilty in these shocking and shameful cases, escape with no punishment, she said.
