As India races towards a vaccine for coronavirus, the government has assured that it will expedite regulatory clearances to ensure it is available as soon as possible. However, all vaccines, including the one for coronavirus, whether domestically manufactured or imported, must comply with the requirements and guidelines specified in the Drugs and Cosmetics Rules, 1945 & New Drugs and Clinical Trials Rules, 2019. Vaccine development is a long process to ensure safety and efficacy through different stages and involves regulatory supervision every step of the way. We take you through this carefully drawn journey of vaccine development from a regulatory