India to prevent unethical drug studies in humans by pharma companies

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Wednesday, June 9, 2010

New laws to prevent pharmaceutical companies from conducting clinical studies of medicines involving humans without obtaining permission from accredited ethical committees may soon come into force in India.

The proposed legislations will form part of a new Bill which the government is going to introduce in the country to restrict unethical practices and streamline the fast-growing clinical research industry in India.

The Union Health Ministry, under the government of India is reportedly finalizing a statute for the biomedical research.

The Indian Council of Medical Research (ICMR), the apex body advising the government on medical research is reportedly working on a draft Bill which proposes the restriction.

The Bill titled ‘Biomedical Research Human Subjects Promotion and Regulation Bill’ may soon be introduced in the parliament.

Presently, there is no apex body to accredit investigators to clinical trials.

Deaths during clinical trials are increasing in India in the recent years even as the country emerges to be one of the most sought-after destinations of human studies of experimental medicines.

According to the figures collated with available information collected, as many as 308 persons died in the year 2009 till the month of August, reports said.

The total number of trials registered in India was 158 in 2009, down by 30% compared to 229 in 2008.

While the number of deaths were pegged at 288 in the year 2008. In  as compared to a 29% growth in 2008. In comparison with the 2008 figures when the number of trials registered showed a 29% growth rate, the death figures in the 2009 were higher.

132 people died while in clinical studies during the year 2007 even though the exact number of clinical studies registered that period when were not available.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.