Last Updated on February 18, 2026
Disclaimer: The lists of DRAP approved CTS, CROs, BA/BE Study Centers & Bio-Analytical Laboratories are prepared with due diligence. It is published only for information, review and feedback from relevant stakeholders and general public. It may not be used as a reference for any other purpose including any claim, legal right, citation or statistical analysis, etc. The contents of these lists cannot be construed as substitute or evidence for validity of licenses of any CTS, CROs, BA/BE Study Centers & Bio-Analytical Laboratories. Errors and omissions excepted.
Contract Research Organizations (CROs)
CROs, as defined by the Bio Study Rules, 2017, are person or organization contracted by the sponsor, for purpose to perform one or more of its trial related activities and functions. These organizations (commercial, academic, or other) are specialized in conducting research and perform one or more of a sponsor’s trial-related duties and functions.
CROs are being regulated under the Bio-Study Rules, 2012. An application to obtain license for working as CROs is required to be submit on Form–I of the Bio-study Rules, 2017, to the Clinical Studies Committee (CSC) of DRAP.
Following is the list of Contract Research Organizations (CROs) licensed by DRAP:-
Bio-Equivalence and Bio-Availability (BE/BA) Studies Centers
The regulatory oversight of Bio-equivalence and bio-availability studies centers is within the scope of Clinical Studies Committee (CSC) under the Bio Study Rules, 2017. BE/BA Centers are required to comply the International Council for Harmonization (ICH) -Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).
Application for licensing of BE/BA Centers are submitted on Form–I to the Clinical Study Committee of DRAP. The license of BE/BA center once approved by the Clinical Studies Committee is valid for 03 years unless it is revoked, suspended or cancelled earlier.
Following Bio-Equivalence and Bio-Availability (BE/BA) Studies Centers are licensed by the DRAP:-
Bio-Analytical Laboratories
Bio-Analytical Laboratories (BALs) are specialized facilities that analyze biological samples to measure drugs, metabolites, and biomarkers. They support clinical trials, bioequivalence studies, and regulatory submissions by ensuring accurate and validated results in line with Good Laboratory Practices (GLP).
Below is the list of approved Bio-Analytical Centers:
Clinical Studies Site (CTS)
Following clinical trials sites are approved by Clinical studies Committee for conduction of Clinical Trials as mentioned in the table below: