Clinical Trials in India

[SaneVax: Is it any wonder clinical trials in India come under suspicion when they are conducted on the mentally ill or the underprivileged members of society? One has to wonder why legislation to protect the participants in clinical trials has been allowed to remain ‘under discussion’ for over eight years.]

Why clinical trials evoke suspicion

By P.T. Jyothi Datta

A clear policy for the industry, with a non-negotiable stance on patient safety, can help dispel the mistrust.

Caveat Emptor?

It is not difficult to see why drug trials on mentally ill patients or the use of cervical-cancer vaccines on tribal girls evokes strong reactions. This is precisely the picture that healthcare workers warn us about, a potentially exploitative situation for vulnerable and marginal people.

But a Government panel investigating the cervical-cancer vaccine trial on tribal girls in Andhra Pradesh and Gujarat had given it an “all clear”. The tribal girls were part of a larger trial that included urban and rural girls, we were told. The niggling questions, though, remain. Was consent taken from the girls, or was it a guardian or a caretaker who gave permission for the girls to participate in the trial?

FUZZY RULES

Question marks arise over the trial of dapoxetine (to treat premature ejaculation) on mentally ill patients. In a written reply to Parliament, Union Health Minister Ghulam Nabi Azad said that psychiatrists at Indore’s Mahatma Gandhi Medical College had enrolled subjects “as per inclusion and exclusion criteria of approved protocol” and the patients were mentally sound.

The Drugs and Cosmetics Act and Rules do not prohibit clinical trials on mentally ill patients, but informed consent needs to be obtained from a legally acceptable representative of the patient, he added.

The classic sitting-on-the-fence reply does not call right from wrong. Why were mentally ill patients part of the study, and not those with all faculties intact? Was it part of a larger study? Or, since psychiatrists prescribe the particular drug, did they naturally enrol people who come to a psychiatrist? In which case, the patient may not be “mentally ill” as commonly understood (meaning not in control of their mental faculties)?

Read the entire article here.

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