The union health ministry has given a clean chit to the controversial
clinical trials involving mentally-challenged patients at Indore in
Madhya Pradesh, following investigations at different levels that found
the trials were done as per the norms.
“The Central Drugs
Standard Control Organization (CDSCO) has investigated the matter
regarding drug trials on patients without their consent by the doctors
of Mahatma Gandhi Medical College and Mental Hospital (MGM), Indore.
Investigations revealed that the psychiatrists attached to the MGM
hospital had conducted 11 clinical trials during the period Jan, 2008 to
Oct, 2010 at their private clinics. In one case only, the investigator
did not have the original Informed Consent Forms at the site as the same
were stated to be in the possession of the sponsor company,” according
to the official information on the issue.
The union health
ministry had also asked the state government to conduct an inquiry into
the alleged violations while the CDSCO, through its West Zone, also
initiated investigations after the reports claimed that trials were done
without consent of the patients.
The Supreme Court also had sent
notices to the Ministry and the Medical Council of India (MCI) on a
petition filed by NGO Swasthya Adhikar Manch seeking probe into the
alleged drug trials without due permissions.
The illegal and
inhuman practice was exposed in Indore during a sting operation carried
out by a news channel some time back. The operation had showed as many
as 233 mentally challenged patients were subjected to clinical trials in
Indore without permission from their family members.
DCGI office
also took views from three companies – Zydus Cadila, mCure and Intas –
on the alleged deficiencies. According to earlier reports, around 233
patients in Indore were subjected to clinical trials to check the
efficacy of drugs, including 42 patients for Dapoxetine, a drug used to
cure premature ejaculation.
