NEW DELHI: Expediting regulatory framework for the Covid-19 vaccine development in India, an empowered committee, under the Department of Biotechnology, has allowed consideration of pre-clinical and clinical data generated outside the country submitted by companies for vaccine approval in India.
It has also allowed submission of parallel application for conducting clinical trials to the Central Drugs Standard Control Organisation (CDSCO) for consideration at the time of conduct of pre-clinical toxicity (PCT) studies.
Based on the recommendation of the Review Committee on Genetic Manipulation (RCGM) and the CDSCO to deal with applications for development of vaccines, diagnostics, prophylactics and therapeutics under Rapid Response Regulatory Framework, the rapid regulatory framework for fast track processing of applications relating to recombinant vaccines has been developed.
“To facilitate the development of the vaccine, a guidance note is issued for the Covid-19 Vaccines Rapid Regulatory pathways. This note is recommendatory and dynamic in nature without prejudice to statutory provisions. Individual application will be examined based on the type of vaccines candidate and their data requirement,” said Nitin K Jain, member secretary of the RCGM.
The note says considering the research collaboration of Indian enterprises with foreign research firms, the pre-clinical studies already done outside India may be considered in a regulatory submission.
“Data generated outside India will be considered and examined and an abbreviated pathway may be considered for Covid-19 vaccine based on scientific rationale and level of completeness of data in human trials in addition to satisfactory preclinical data. Phase I/II or phase III multicentric study on statistically significant sample size may be considered based on, initial safety studies, proof of concept and dose-finding data,” it added.