The Verification-CECA route is implemented under the Comprehensive Economic Cooperation Agreement (CECA) between India and Singapore to facilitate market entry of India-manufactured generic products into Singapore.
Generic drugs eligible for registration under the Verification-CECA route must meet the following criteria:
a) Must be manufactured at a licensed manufacturing facility in India;
b) The product must be approved by at least one of HSA’s reference agencies (US FDA, EMA, UK MHRA, Australia TGA and Health Canada) within two years from the date of submission to HSA; and,
c) All aspects of the generic product's quality, including formulation, manufacturing site(s), specifications and primary packaging, must be identical to that approved by the reference agency.