CDSCO tightens drug safety reporting forcing firms to file from launch date of new drugs

Safety reports now start when the drug actually hits markets

India’s drug regulator CDSCO has tightened rules for drug safety reporting. Pharma firms must file safety reports starting from the actual launch date of new drugs rather than the approval date. The regulator says this will better capture real-world safety signals. It also brings all forms and uses of a new drug under one consolidated safety report.