A No Objection Certificate to produce vaccine candidate for analytical, test purposes from DGCI. If vaccine is recombinant or involves genetic tweaks, it needs approval from Review Committee on Genetic Manipulation, Department of Biotechnology
Apply for Test Licence from State Drugs Controller
Joint inspection of facility by Central and State Drugs Control Authorities. If satisfied, State Drugs Controller gives test licence
GET APPROVAL FOR STUDY PROTOCOL FOR PRE-CLINICAL TOXICITY TRIALS IN ANIMALS FROM INSTITUTIONAL ANIMAL ETHICS COMMITTEE, RECOGNISED BY ICMR
Once pre-clinical trial protocol approved, produce test batches and apply to DCGI for permission to conduct pre-clinical toxicity studies in animals
After pre-clinical toxicity studies, data and product samples submitted for official vetting to Central Drugs Laboratory (CDL), Kasauli
Submit CDL test reports to DCGI for permission to conduct human…