India Government Cracks Down on Biomed Researchers

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India Government Cracks Down on Biomed Researchers

By Subhadra Menon, PhD. Friday January 4 5:16 PM ET

NEW DELHI (Reuters Health) - India's Ministry of Health and Family

Welfare has ordered that all clinical trials at the Regional Cancer

Center (RCC) in Trivandrum, Kerala be suspended for 6 months.

This action is in response to the RCC cancer drug trial controversy

that erupted some months ago. The RCC had been conducting

unauthorized trials of the drugs M4N and G4N on unsuspecting cancer

patients, in collaboration with a scientist from s Hopkins

University in Baltimore, land.

India's Union Health Minister Dr. C. P. Thakur has also officially

announced that his government will censure the scientists involved in

the trials. If the government finds any future violations of Indian

Council for Medical Research (ICMR) ethical guidelines, he said, it

will place a lifetime ban on the concerned scientist and the

institution.

Meanwhile, the government is also planning to conduct a nationwide

review of all ongoing research involving clinical trials.

These announcements come even as the results of the central and

Kerala state government inquiry reports into the trials are yet to be

revealed.

After the 6-month ban at the RCC is over, all clinical trials at the

institute will be reviewed and permission will be granted only for

trials cleared by the Drugs Controller General of India and the

health ministry's screening committee.

Dr. Sri Ram Khanna, honorary managing trustee of the Delhi-based

Voluntary Organization in Interest of Consumer Education (VOICE),

which works to spread awareness about consumer rights, called the

government's move a ``knee-jerk'' reaction. Without a larger effort

to create regulation and transparency, Khanna said, the government's

action is of little use.

Meanwhile, the government has also advised the RCC to reconstitute

its Ethics Committee by co-opting a representative from the ICMR.

These most recent measures, according to the health minister, are

meant as a clear indication of India's policy on biomedical research.

The government has said, in its official press note on the subject,

that while biomedical research is to be encouraged, the government

will not tolerate any violations.

Thakur also believes these measures will send signals to the research

community both within and outside the country that Indians cannot be

treated as guinea pigs.

But more extensive reform is needed, according to Khanna. ''The

government should be working towards creating a transparent, strictly

regulated system, whereby all companies and institutions are governed

by the same set of mandatory rules when it comes to testing new

drugs,'' he said.

He added that VOICE believes the Ministry of Health and Family

Welfare should be able to quickly put in place such a rigorous system

of regulation, as far as drug trials on humans are concerned

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