The Government of India, Ministry of Science & Technology, Department of Biotechnology(DBT) vide its Office Memorandum dated 26th May 2020 published guidance note for a rapid regulatory framework for fast track processing of applications relating to recombinant vaccines for COVID-19 based on the recommendation of the empowered committee of RCGM and CDSCO.
The empowered committee was set up by DBT on March 20, 2020, to deal with applications for development of vaccines, diagnostics, prophylactics and therapeutics under Rapid Response Regulatory Framework for COVID-19.
This guidance document is recommendatory and dynamic in nature without prejudice to statutory provisions. The individual application will be examined based on the type of vaccines candidate and their data requirement.
As per the guidance note, preclinical studies already done outside India may be considered in regulatory submission and individual application will be examined based on the quality of data generated. The conduct of limited preclinical study may be asked for after examination, if required.
The DBT has permitted applicants to submit a parallel application for conducting an appropriate phase of the clinical trial to Central Drugs Standard Control Organisation (CDSCO) for consideration at the time of conduct of pre-clinical toxicity (PCT) studies based on proof of concept. However, the application for the clinical trial will be approved subject to no objection certificate from the Review Committee on Genetic Manipulation (RCGM) after examination of data of preclinical studies.
Further, a checklist for application to conduct pre-clinical toxicity (PCT) studies for recombinant vaccine development for COVID-19 has also been attached with the OM.
Click here to read the Notification.
