India sets out new guidelines for clinical trials with children

12 October 2015

After tackling vaccination against seven diseases, the Indian government has set its sights on bio-medical research involving children, reports The Pharma Letter’s India correspondent.

The Indian Council of Medical Research has drafted new guidelines on clinical trials with children, stating that the child’s approval would be compulsory in order to take part in any clinical trial.

A spate of fatalities among subjects of clinical trials in India, which made international headlines, and the death of 49 children in six clinical trials conducted at India's premier institute, the All India Institute of Medical Sciences (AIIMS) several years ago, proved to be the proverbial last straw and instrumental in moving the Indian government to shake up its rules on clinical trials involving children.

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