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CPM decries DCGI silence over Indore drug trials
The CPI (M) on Friday blamed the Drugs Controller General of India (DCGI) for its “silence” despite violations having been found by different authorities in the recent controversial clinical trials in Indore. CPI(M) Politburo member Brinda Karat urged the DCGI to initiate immediate action against the persons involved in the issue and blacklist the concerned pharma companies.
“You are no doubt aware of the shocking facts of the notorious Indore drug trials in which senior doctors in Government hospitals and also private doctors flagrantly violated minimum ethical standards in conducting clinical trials on their patients without informed consent. You are also no doubt aware that the Chair of the Ethics Committee in the MGM Hospital, one of the main hospitals, which had conducted the illegal trials, has himself been found guilty of unethical practices.
“There are several issues involved (a) the lack of informed consent from the subjects of the trials (b) the vulnerability of the subjects, almost all 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,” said Brinda in a letter to the Drugs Controller General.
The CPI(M) leader also criticised the Madhya Pradesh Government for providing escape route by imposing small fines on the doctors who connived with pharma companies.
“While these are clear violations for which the licences 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 ICMR or MCI guidelines, there should be further investigations by the DCGI and the ICMR,” said Brinda.
The CPI (M) on Friday blamed the Drugs Controller General of India (DCGI) for its “silence” despite violations having been found by different authorities in the recent controversial clinical trials in Indore. CPI(M) Politburo member Brinda Karat urged the DCGI to initiate immediate action against the persons involved in the issue and blacklist the concerned pharma companies.
“You are no doubt aware of the shocking facts of the notorious Indore drug trials in which senior doctors in Government hospitals and also private doctors flagrantly violated minimum ethical standards in conducting clinical trials on their patients without informed consent. You are also no doubt aware that the Chair of the Ethics Committee in the MGM Hospital, one of the main hospitals, which had conducted the illegal trials, has himself been found guilty of unethical practices.
“There are several issues involved (a) the lack of informed consent from the subjects of the trials (b) the vulnerability of the subjects, almost all 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,” said Brinda in a letter to the Drugs Controller General.
The CPI(M) leader also criticised the Madhya Pradesh Government for providing escape route by imposing small fines on the doctors who connived with pharma companies.
“While these are clear violations for which the licences 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 ICMR or MCI guidelines, there should be further investigations by the DCGI and the ICMR,” said Brinda.
