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Call to monitor drug trials on human beings

Staff Reporter

`People of the labour class being used as guinea pigs'

Bangalore: A proper regulatory mechanism has to be developed to monitor clinical trials of drugs on human beings, especially in developing countries such as India, Suresh Nagpal, Chairman of the Journal of Pharmaceutical Research, said here on Saturday.

He was speaking at the inauguration of the two-day Pharmacovigilance and Drug Safety Conference 2006 organised by the Society of Pharmacovigilance (India) here. Prof. Nagpal said that in many developing countries including India, the people of the labour class were used as guinea pigs for clinical trials without much thought about their safety.

Screening

Proper pre-clinical trials have to be done before conducting trials on human beings. All clinical trials should be screened and monitored so that the people do not take advantage of the poor," he said.

Suitable follow-up of the people on whom clinical trials were done had to be conducted so that long-term toxicity of these drugs could be studied, he said.

Giampaolo Velo, President of the International Society of Pharmacovigilance, London, who inaugurated the conference said that drug safety was a major concern as adverse drug reactions could be serious and even fatal. No drug had a single action. The multiple actions of drugs were not always beneficial and unwanted effects might be potentially harmful, Prof. Nagpal said.

Proper screening of drugs is necessary and people should be given adequate information about drug interactions. A system had to be developed for carrying out such screening, Dr. Velo said.

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