BA / BE

What is BA / BE

Bioavailability (BA) : Bioavailability refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation.

Bioequivalence (BE): Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.


Also read: Suggestion on bio-equivalence studies under Rule 122 DAA

DCGI Notice 13-03-20 – Requirement of process validation report for permission to conduct Clinical trial / BA-BE studies

DCGI-Notice-13-03-20-Requirement-of-process-validation-report-for-permission-to-conduct-Clinical-trial-BA-BE-studies

DCGI has issued notice on 21-02-2020 regarding sub acute toxicity study report for injectable products for BA BE study in human for export

DCGI has issued notice on 21-02-2020 regarding stability data for BA BE study in human for export

DCGI has issued notice on 21-02-2020 regarding Processing of application for BA BE permission issued in Form CT-07 import license issued in CT-17

DCGI has issued notice on 21-02-2020 regarding permission to conduct BA BE studies and clinical trial

DCGI has issued a notice 27-01-2020 regarding Processing of post approval to BA BE permission issued in Form CT-07, import license issued in CT-17

DCGI has issued a notice 22-01-2020 regarding – List of Reference Products for Conduct of BE Study. Click below for more information:

How to obtain approval of BA / BE

For obtaining obtain approval of BA / BE, the list of documents required is provided below. Download the pdf file and prepare the documents accordingly.

Download the below pdf files for list of approved BA /BE Centres