In this handout photo released by the University of Oxford samples from coronavirus vaccine trials are handled inside the Oxford Vaccine Group laboratory in Oxford, England Thursday June 25, 2020. | Photo Credit:
AP
Firms could get leeway in India-specific tests and trials, says DBT
Indian companies looking to import or test potential COVID-19 vaccines, that have been developed internationally, could get leeway in the number of India-specific tests and trials they would need conduct, says a guidance document from the Department of Biotechnology (DBT).
Normally, a vaccine that has been licensed in another country, would still need to repeat all human safety tests in India.
Use of earlier data
“Data generated outside India will be considered and examined and an abbreviated pathway may be considered for COVID-19 vaccine based on scientific rational and level of completeness of data in human trials in addition to satisfactory pre-clinical data. Phase I/II or phase III multi-centric study on statistically significant sample size may be considered based on, initial safety studies, proof of concept and dose finding data,” says the document that was published on May 23, but has only now