Last Updated on May 7, 2023
The Clinical Studies Committee have been rejected following applications regarding the Clinical trials due to non compliance of the rules, regulations and procedures implemented by the DRAP under BSR, 2017.
| Sr. No. | Rejection Date | CSC No. | Title of Study/ Trial/ Case |
|---|---|---|---|
| 1 | 2/5/2020 | CSC-11 | To determine the bioequivalence of test product Clarithro® 500mg Tablets manufactured by M/s Nabiqasim Industries (Pvt) Ltd, Karachi in health adult human subjects, compared with reference product Klaricid® 500mg Tablets, Manufactured by M/s Abbot Laboratories, Karachi. |
| 2 | 2/5/2020 | CSC-11 | A comparative, open labelled, multicentre, parallel arm, controlled, and randomized study with 2 parallel groups to compare the efficacy and safety of test drug (Megafer Injection) with reference (Venofer Injection) in outpatient woman with Iron deficiency anaemia (IDA). |
| 3 | 2/5/2020 | CSC-11 | An open labelled, controlled, and randomized study with 2 parallel groups to compare the efficacy and safety of test drug (Rexyl cough syrup) with reference (Hydryllin cough syrup) in adult outpatients with productive cough. |
| 4 | 2/5/2020 | CSC-11 | OPEN LABEL, NON-RANDOMIZED, MULTI-CENTER INVESTIGATOR INITIATED STUDY TO EVALUATE EFFECTIVENESS OF GENERIC VELPATASVIR AND SOFOSBUVIR IN HEPATITIS-C WITH OR WITHOUT RIBAVIRIN AMONG PAKISTANI POPULATION |
| 5 | 13-10-2022 | CSC-35 | PROTECTS CLINICAL TRIAL TITLED HYDROXYCHLOROQUINE, OSELTAMIVIR AND AZITHROMYCIN FOR THE TRAETMENT OF COVID-19. |
| 6 | 13-10-2022 | CSC-35 | APPROVAL OF REHMAN MEDICAL CENTER, PESHAWAR TO ACT AS CLINICAL TRIAL SITE FOR PHASE-II CLINICAL TRIALS. |
| 7 | 21-11-2022 | CSC-36 | LICENSE TO ACT AS CLINICAL TRIAL SITE (CTS) FOR PHASE-II (TRIAL SPECIFIC) FROM M/S ABDUL WAHEED TRUST (AVICEENA DENTAL COLLEGE), LAHORE. |
| 8 | 20-01-2020 | CSC-06 | Pioneer Research Solutions (Pvt) Ltd, For CRO, |