Health Ministry issues draft notification to amend compensation clause under Rule 122-DAB

  • 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.