BA / BE Studies

Table of Contents

Last Updated on June 16, 2026 by The Health Master

BA / BE Studies

What is BA / BE

Bioavailability (BA): Bioavailability refers to the relative amount of drug from an administered dosage form 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

FAQs on BA / BE Studies

FAQs on Prior Intimation Application for BA BE study for Export purpose under NDCT Rules 2019 amended as per GSR 50(E) dt 21-01-2026

FAQs on BA BE study for Export Application

DCGI Notices

2021

DCGI dt 02-08-2021 – Updated list of BA-BE Study centre & Bio Analytical Laboratory under New CT RULE 2019

DCGI-dt-02-08-2021-Updated-list-of-BA-BE-Study-centre-Bio-Analytical-Laboratory-under-New-CT-RULE-2019

2020

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-Notice-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-Notice-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-Notice-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-Notice-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-Notice-27-01-2020-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:

DCGI-Notice-22-01-2020-List-of-Reference-Products-for-Conduct-of-BE-Study

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.

Document-required-for-approval-BA-BE