(Weekly Organ of the Communist Party of India (Marxist)
January 15, 2012
CPI(M) Leader Demands Urgent Action
IN a letter
written to Dr V G Somani,
the Drug Controller General of India (DCGI), on January 4, 2012, CPI(M)
Bureau member and former Rajya Sabha member, Ms Brinda Karat, drew the
attention to the shocking fact of the notorious
There are several issues involved, the letter said. These include (a) lack of informed consent from the subjects of the trials, and (b) the vulnerability of the subjects, as almost everyone of them is from poor sections of the population and was, 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.
The Madhya Pradesh government had earlier set up an enquiry under the NHCE Act of Madhya Pradesh, and the enquiry found some of the doctors guilty of not reporting the trials, not keeping records etc. For these violations, however, they were fined a small amount only. In yet another enquiry conducted by the Economic Offences Wing of the state government, it was found that doctors conducting the trials in government hospitals were paid per subject recruited and that these 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 enquiry report had also specifically recommended that as far as the violations of the Drugs and Cosmetics Act as well as violations of the guidelines issued by the Indian Council of Medical Research (ICMR) or Medical Council of India (MCI) are concerned, there should be further investigations by the DCGI and the ICMR.
pointedly asked the
following questions: Has the DCGI received the report? Is the DCGI
aware of the
multiple violations that have taken place in the conduct of the trials
regarding the absence of informed consent, vulnerability of the
conflict of interests of the doctors conducting the trials, number of
adverse events that have occurred on subjects of the trials etc, and
of the Ethics Committees? Since the
While noting that these serious violations of the clinical trials have gone unpunished, Brinda Karatís letter also pointed out that apart from the doctors involved, the pharma companies who sponsored these trials must also be held responsible under the law for these violations. Unfortunately, the latter said, it is the power of these powerful lobbies which prevail and the guilty in these shocking and shameful cases escape unpunished.
leader said in plain terms
Institution of a time-bound enquiry
(2) Coverage in the scope of the enquiry the members of the Ethics Committee who acquiesced in these violations.
(3) Blacklisting of the companies that sponsor the trials in which these violations have occurred.
(4) Recommendation of cancellation of the licenses of doctors involved.
leader stressed that it is
only stringent action which would help eliminate the gross violations
law in the conduct of clinical trials, of which the