CDSCO approves 12 laboratories for BA/BE studies

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CDSCO FDA

Last Updated on August 6, 2021 by The Health Master

The Central Drugs Standard Control Organisation (CDSCO) has issued approval to 12 laboratories in the first six months of the year 2021, to conduct bioavailability, bioequivalence (BA/BE) tests in the country.

Under the new Clinical Trial Rules, 2019, from June, 2019, the drug regulatory organisation has issued approval to almost 80 laboratories to conduct BA/BE, bio analytical labs in the country.

The 12 laboratories which received approval from the CDSCO for BA/BE studies include Jubilant Generics Ltd, Reliance Clinical Research Labs Ltd and Sun Pharmaceutical Industries Ltd, for a period of five years.

One laboratory – Cliwis Lab Pvt Ltd – was approved as a standalone bio-analytical lab, was also issued with an approval to conduct tests as per the rules.

Four laboratories, which were old approved laboratories, including Wockhardt CPB, Micro Labs Ltd, CBCC Global Research LLP and ClinSync Clinical Research Pvt Ltd have their approval for BA/BE study till towards the end of 2021.

According to the data released by the CDSCO, almost 17 laboratories were approved during 2019, and around 47 in 2020.

Data prior to the implementation of the Clinical Trial Rules 2019 shows that around 80 laboratories were approved for BA/BE studies in the country, as on January 29, 2019, while 17 bio analytical laboratories were also approved under the rule.

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