India Profile Updated with DCGI Order Regarding Local Clinical Trial Waivers

The India profile in ClinRegs has been updated to include an order issued by the Drugs Controller General of India (DCGI) specifying countries for which the DCGI may waive the requirement to conduct a local clinical trial if the new drug is already approved in one of the named countries and certain conditions are met. (See Scope of Assessment)

Sources Added During this Update:

(Order) Order Specifying Names of Countries under Rule 101 of the New Drugs and Clinical Trial Rules, 2019 as it Relates to New Drug Approval (Order7Aug24) (August 7, 2024)
Central Drugs Standard Control Organization