A COMPREHENSIVE STUDY OF INDIA'S REGULATORY FRAMES FOR ADOPTION OF REPURPOSED DRUG AS COVID-19 TREATMENT

Drug repurposing reflects an innovative approach to drug development to explore potential therapeutic advantages in clinical trials. The strategy is employed to overcome the bottlenecks in terms of financial assistance, time and money during conventional drug development. Several data driven and creative methods for identifying repurposable drug candidates have been suggested. However significant challenges related to technology and regulatory requirements have to be overcome. The regulatory guidelines and procedures are of paramount importance for pharmaceutical companies to obtain manufacturing licence from the drug regulator. CDSCO, the Indian drug regulator as clear guidelines and procedure for obtaining any manufacturing licence of any new drug or formulation or vaccine. A repurposed drug as to undergo one of the two alternative pathways before obtaining necessary regulatory clearances. A repurposed drug as to be tested for safety and efficacy for the treatment of the intended or proposed disease. Therefore, it as to undergo necessary clinical trials followed by formulation development and technology transfer from research and development to the production department. The regulatory approvals are required to conduct clinical trials, formulation development and commercial manufacturing. Data should be submitted after clinical trials as well as formulation development work to the Indian regulator work through specific forms and procedure. The regulator will review the data and the decision to move to the next stage. This article is the result of a comprehensive study of the regulatory framework that has to be followed by pharmaceutical company to commercialize repurposed drugs. Generic products have a different procedure.