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LATEST NEWS UPDATES | WHO tells govt strict clinical trial rules will drive away drug firms -Teena Thacker

WHO tells govt strict clinical trial rules will drive away drug firms -Teena Thacker

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published Published on Jul 12, 2018   modified Modified on Jul 12, 2018
-Livemint.com

WHO says the Indian govt should ‘reconsider’ the compensation clause because an approval to the rules in the current form would affect the conduct of clinical trials in India

New Delhi:
The World Health Organization (WHO) has told the central government that the United Nations (UN) agency’s work with India would be “hampered” and drug companies driven away if the government goes ahead with stringent draft rules for compensation in case of death or injury from clinical trials.

In a letter to health secretary Preeti Sudan on 19 June, WHO deputy director general Soumya Swaminathan said India should “reconsider” the compensation clause because an approval to the rules in the current form would affect the conduct of international and nationally-sponsored clinical trials in India.

The Union health ministry’s proposals made in February included a provision for the deceased party in a trial to be paid 60% of the compensation within 15 days if the patient dies or suffers a permanent disability in the course of a trial.

Additionally, if it is proved after an investigation that the death or disability did not occur because of the trial, the interim compensation will not be returned.

According to the proposed rules, if the injury is related to a clinical trial in addition to the medical management, the participant would also be provided financial compensation by the sponsor as determined by a proposed ethics committee (EC). The financial compensation would be over and above any expenses incurred in medical management of the subject.

The ethics committee is a proposed government body that will ensure medical experiments and research on humans are carried out in an ethical manner and provide feedback on the ethical appropriateness of the trial. It will consist of seven members, including experts from medical science, non-medical stream, scientific and non-scientific members, a layman and a woman member, said an official at the Central Drugs Standard Control Organization, who requested anonymity.

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Livemint.com, 10 July, 2018, https://www.livemint.com/Industry/pdHu6zfNmDDCnHDbh1svVP/WHO-tells-govt-strict-clinical-trial-rules-will-drive-away-d.html


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