17/18 March 2021
India's CDSCO (Central Drugs Standard Control Organization) has released a new draft bill amending Drugs and Cosmetics Act from 1940. The document is called "Draft Drugs and Cosmetics (Amendment) Bill".
One goal is to include a rule on compensation. If a trial causes harm to a patient, the sponsor will have to pay for the patient or its family.
"Where death of a participant is caused due to clinical trial, the person or a body permitted under section 4A and the sponsor shall provide to his legal heir, such compensation, in such manner as may be prescribed", the document states in its Clinical Trials chapter.
Besides compensation for injury or death due to clinical trial, the key tasks of the chapter on Clinical Trials are: