The Hindu : Karnataka News : Norms for regulating clinical trials planned

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Thursday, May 26, 2011
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Karnataka

Karnataka

Norms for regulating clinical trials planned

Special Correspondent

Two-member expert panel to put their heads together to evolve legislation

Need to define role of drug companies, hospitals, patients in clinical trails
Generic drugs to be made available for patients in 22 places in State

BANGALORE: The State Government will constitute a two-member committee of experts to recommend norms for regulating clinical trials in the State, which will serve as supporting material for evolving a legislation on clinical trials.

Minister for Medical Education S.A. Ramdas told presspersons here on Wednesday that A S. Arvind, a former researcher in Biocon, and Mahabaleshwara Maiya, a retired physician and cardiologist in Victoria Hospital, will be the two members of the committee which has been given two months to submit its report. The committee will deal with various issues related to clinical trial aspects, including norms necessary for regulation, mandatory procedures and practices.

Chief Minister B.S. Yeddyurappa, Chief Secretary to the State Government and the Advocate-General would go through the report of the committee and take a final decision on the nature of the proposed Bills on regulation of clinical trials to be prepared by the State Government.

Stressing the need for evolving a legislation to regulate clinical trials, he noted that there were well established standardised norms governing clinical trials in advanced countries. There was a need to evolve such norms in India also to define the role of all those involved in clinical trials, including drug companies, medical institutions and patients, he said.

Generic drugs

The Minister said generic drugs will be made available for patients in 22 places in the State, including district hospitals and government medical institutions in about three months. These medicines will be sold by the respective manufacturing companies at the counters to be set up in the above hospitals. He noted that these medicines will be available at a rate 50 per cent lower than the prices of the branded drugs available in the market.

Referring to the episode of the Karnataka High Court quashing the appointments made in the government medical colleges in Mysore and Hassan, he said the government had now prepared a list of candidates to fill up 45 posts in Mysore and 307 posts in Hassan on the basis of merit. A fortnight's time will be given for receiving objections, if any, for the list. Then, these objections would be placed before the Advocate-General for examining within fifteen days. The appointment process would be completed within 30 days, he said.

Lapses found

Mr. Ramdas said an inquiry committee, headed by a retired district judge, had looked into lapses in the Government Medical College in Mandya.

It had found that 12 doctors had submitted fake documents to get jobs. He said action would be taken against those doctors.

The committee had found various lapses in procedures, including illegal appointments, lapses in administration and violation of norms in purchase of equipment.

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