Last Updated on October 22, 2024
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:-
| LIST OF APPROVED BA/BE STUDIES CENTERS, UNDER THE BIO-STUDY RULES. | ||||||
|---|---|---|---|---|---|---|
| S.# | License # | Name of BA/BE Center | Address of BA/BE Center | Date of Issuance/Renewal of licence. | Date of expiry of licence. | Status |
| 00001 | BA/BE-C- 0001 | M/s Pharma Professional Services (Pvt.) Ltd, Karachi. | Plot No. A-93 Ettawah society, Ahsan Abad, [near Gulshan-e- Maymar], Gadap Town, Karachi. | 30th October 2019. | 29th October 2022. | Expired |
| 00002 | BA/BE-C- 0002 | M/s Center for Bioequivalence Studies and Clinical Research (CBSCR), At International Center for Chemical and Biological Sciences (ICCBS), University of Karachi, Karachi. | M/s Center for Bioequivalence Studies and Clinical Research (CBSCR), At International Center for Chemical and Biological Sciences (ICCBS), University of Karachi, Karachi. | 21st February 2020. | 20th February 2023. | Valid Inspection pending |
| 00003 | BA/BE-C- 0003 | M/s Olive Worldwide (SMC- PVT) Ltd, Lahore. | 3-4-5 M, Model Town Extension, Lahore. | 17th December 2020. | 16th December 2023. | Expired |
| 00004 | BA/BE-C- 0004 | M/s Institute of Biological, Biochemical and Pharmaceutical Sciences (IBBPS), Dow University of Health Sciences, Karachi | Dow University of Health Sciences, Karachi, KDA Scheme 33, Gulzar-e-Hijri, SUPARCO Road, Ojha Campus, Karachi, Pakistan | 24th December 2020. | 23rd December 2023. | Valid Inspection pending |
| 00005 | BA/BE-C- 0005 | M/s Pakistan Drug Testing & Research Center (PDTRC) Lahore | Commercial Area North, Sundar Industrial Estate, Raiwind Road, Lahore, Punjab, Pakistan. | 28th October 2021. | 27th October 2024. | Valid |
| * Errors and omissions expected & may be reported. | ||||||