The Hindu : Andhra Pradesh / Hyderabad News : State mulls law to regulate clinical trials

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Monday, Jun 20, 2011
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Andhra Pradesh

Andhra Pradesh - Hyderabad

State mulls law to regulate clinical trials

M.L. Melly Maitreyi

Laboratory of M/s Axis Clinical Ltd not registered with the State government
A detailed report on Piduguralla episode may take some more time

HYDERABAD: Rattled by the unethical manner in which some poor people of Piduguralla in Guntur district were subjected to clinical trials and growing pattern of such instances, the State government is veering round to bringing its own legislation for regulation and monitoring of clinical trials.

The Director General, Drug Administration, R.P. Meena, who is conducting the inquiry into health complications developed by some poor women following clinical trials, said on Friday that the State had no control over the clinical trials as they were allowed by the Central Drug Authority and the Indian Council of Medical Research.

Dr. P.V.Ramesh, Principal Secretary, Medical and Health, meanwhile told The Hindu on Saturday that a detailed report by Mr. Meena would take some more time. Three drug inspectors were still verifying the records of the M/s Axis Clinical Ltd that was sealed after the District Medical and Health Officer in her inspection found that the laboratory had no registration with the State government.

Meanwhile, highly placed sources said that though clinical trials were under the purview of the Centre, what happened in Piduguralla was a clear case of unethical practice -- offering inducements to the ignorant poor to agree for the drug trials.

Such consents were no consent at all. To protect people from dire consequences of unethical trials, the State government has been considering various options including its own legislation.

Though health is in the concurrent subjects list, Centre in its wisdom decided only on Central legislation for drug control and administration.

Owing to stringent laws in the West, India has become a preferred destination for the pharmaceutical companies conducting clinical trials. The cheaper cost and relatively easy regulations were other attractions.

While Hyderabad became a hub of pharmaceutical companies and the clinical trials for the foreign and domestic companies bringing in good income, instances of people suffering from complications also were on the rise.

“Given the increasing cases of clinical trials going wrong, a legislation coupled with a regulating machinery will have necessary checks over clinical trials. However it needs to be debated at all levels,” sources said..

Even though drug trials were inevitable to test the efficacy of drug finally on human beings, at least existing Central legislation can be strengthened to ensure required safeguards -- maintaining a registry of companies conducting clinical trials in the States, periodical review of such trials by a competent body, protocol for seeking consent and also consent giving process. Such measures would help the State to check poor and uninformed people being used as guinea pigs, sources added..

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