Health Ministry issues draft notification to amend certain clauses relating to clinical trials

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The Union health ministry has issued draft notification making changes to the Drugs and Cosmetics Rules 1945 regarding the clinical trials to insert new clauses and change some existing clauses under Rule 122-DAB and Schedule Y.

“In the case of an injury occurring to the subject during the clinical trial, he or she shall be given free medical management as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier,” according to the new sub-rule (1) in Rule 122-DAB.

Likewise, a sub-rule (2) will be inserted to define the quantum of compensation. “In case there is no permanent injury, the quantum of compensation shall commensurate with the nature of the non-permanent injury, loss of wages and transportation,” it said.

The draft rules were issued after consultation with the Drugs Technical Advisory Board and the government has sought comments and suggestions in this regard within the stipulated 45 days.

The notification also substitutes clause IV in the paragraph relating to clinical trials under the Schedule Y. “Any report of the serious adverse event, after due analysis shall be forwarded by the sponsor to the Licensing Authority as referred to in clause (b) of rule 21, chairman of the Ethics Committee and the Head of the Institution where the trial has been conducted within fourteen calendar days of the occurrence of the serious adverse event,” the amended rule says.

“In case the Investigator fails to report any serious adverse event within the stipulated period, he shall have to furnish the reason for the delay to the satisfaction of the Licensing Authority along with the report of the serious adverse event. The report of the serious adverse event, after due analysis shall be forwarded by the investigator to the Licensing Authority as referred to in clause (b) of rule 21, chairman of the Ethics Committee and the Head of the Institution where the trial has been conducted within fourteen calendar days of the occurrence of the serious adverse event,” says another insertion in the Rule.

Source: PharmaBiz

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