India's Regulatory Frames for Adoption of Repurposed Drugs as Covid-19 Treatment: A Recent Study Approach

Currently, there are no treatment options available for the fatal contagious disease, coronavirus disease 2019 (COVID-19). The COVID-19 disease caused by the SARS-CoV-2 coronavirus is a global public health emergency. The SARS-CoV-2-caused COVID-19 pandemic represents an unprecedented health threat, necessitating the quick development of antiviral treatments. Repurposing a medicine exemplifies a new strategy for drug development in order to investigate possible therapeutic benefits in clinical trials. The technique is applied to overcome the bottlenecks of financial support, time, and money in conventional drug development. Several innovative and data-driven approaches to identifying repurposable medication candidates have been proposed. Nevertheless, substantial technological and regulatory obstacles must be surmounted. Several medications were approved for the treatment of COVID-19 patients as a result of the repurposed SARS-CoV-2 treatments. For pharmaceutical businesses to receive a manufacturing licence from the drug regulator, it is crucial that they adhere to the regulatory rules and procedures. The Indian drug regulator, CDSCO, has specific criteria and procedures for getting a manufacturing licence for every new medicine, formulation, or vaccination. Clinical trials, formulation development, and commercial manufacturing all require regulatory authorization. After clinical trials and formulation development, particular forms and processes should be used to submit data to the Indian regulatory agency. The regulator will assess the information and the decision to proceed to the next phase. This article is the product of an exhaustive investigation into the regulatory framework that a pharmaceutical company must adhere to in order to sell repurposed pharmaceuticals. Generic brands have a distinct manufacturing process.