The Drug Controller General of India (DCGI) has issued a show cause
notice to five doctors of Indore's Mahatma Gandhi Medical College (MGMC)
for not following clinical trials norms while conducting them on 241
patients , who visited MGMC's psychiatry ward.
Notices have also
been sent to three companies - Zydus Cadila, Mcure and Intas - to
explain the deficiencies at the earliest. The DCGI has threatened to
blacklist the doctors from all other trials they are involved in if they
fail to reply at the earliest. 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.
An independent team of investigators - sent by the DCGI - submitted its report to thehealth ministry on Monday.
The report has cleared the investigators of carrying out the trial on
"mentally ill" patients . The investigating team, however, took
cognizance to the fact that investigators did not possess with them the
original consent forms. The forms were taken away by the sponsors of the
trial, "which is a serious offence" .
A ministry official said,
"Most of the patients were suffering from erectile dysfunctions and were
being treated by psychiatrists from that medical college." He added,
"However, show cause notices have been served on the doctors for serious
administrative lapses and deviation from GCT guidelines while carrying
out the trial."
The charges against the doctors by are that they
had photocopies of consent forms instead of the original, had taken
approval for the trials from independent ethics committees attached to
private hospitals and did not inform the MGMC where they work as
employees.
