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. | Date | CSC No. | Title of Study/ Trial | Clinical Research activity Status | Remarks Reference (if any) |
|---|---|---|---|---|---|
| 1 | 20/1/2020 | CSC-06 | Pioneer Research Solutions (Pvt) Ltd., Islamabad For CRO. (Application to act as Contract Research Organization-CRO) | Contract Research Organization-CRO | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and based on non-compliance to codal requirements, decided to reject the application. |
| 2 | 2/5/2020 | CSC-11 | Study title: "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." | Bioequivalence Study | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and upon request of PI, decided to reject the application. |
| 3 | 2/5/2020 | CSC-11 | Study title: "A Single Center, Open Label, Randomized, Single Dose, Two way Cross-over Study to explore the Relative Bioavailability of Moksi (Moxifloxacin) 400mg Tablet of M/s Abbott Laboratories and Avelox (Moxifloxacin) 400mg Tablet of M/s Bayer Pharmaceuticals under the fasting conditions in Healthy Male Pakistani Subjects. | Bioavailability Study | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and based on non-compliance to codal requirements, decided to reject the application. |
| 4 | 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). | Clinical Trial | Applicant in reference to this division reminder letter number F.No.14-11/2018 DD (PS) dated 20th April 2020 submitted withdrawal letter from subject application, Hence CSC decided to reject the case for further processing. |
| 5 | 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. | Clinical Trial | Applicant in reference to this division reminder letter number F.No.14-11/2018 DD (PS) dated 20th April 2020 submitted withdrawal letter from subject application, Hence CSC decided to reject the case for further processing. |
| 6 | 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. | Clinical Trial | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and based on non-compliance to codal requirements, decided to reject the application. |
| 7 | 12/2/2021 | CSC-19 | Convalescent plasma treatment in covid-19 patients: non-randomised open label clinical trial at a tertiary care center in Pakistan. | Clinical Trial | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and based on non-compliance to codal requirements like even fee submission, decided to reject the application. |
| 7 | 13/10/2022 | CSC-35 | Clinical Trial Titled Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of Covid-19. | Clinical Trial | The CSC after detailed discussion and deliberations decided to reject the case due to noncompliance |
| 13/10/2022 | CSC-35 | “Open label, two cohorts (with & without Imiglucerase), multicenter study to evaluate pharmacokinetics, safety & efficacy of eliglustat in pediatric patient with gaucher disease type 1 and type 3 (Elikids).” | Clinical Trial | The applicant asked for termination of the subject trial/study initiation process in Pakistan on 10th June, 2022, due to non-compliance to codal requirements, CSC decided to reject the application. | |
| 8 | 13/10/2022 | CSC-35 | Approval of Rehman Medical Center, Peshawar To act as Clinical Trial Site for Phase-II Clinical Trials. | Clinical Trial Site | Applicant repeatedly informed and directed for fulfilment of shortcomings by Clinical Trial Section, DRAP but applicant not responded. So, CSC after deliberations and based on non-compliance to codal requirements, decided to reject the application. |
| 9 | 21/11/2022 | CSC-36 | Clinical Trial Site (CTS) For Phase-II (Trial Specific) From M/s Abdul Waheed Trust (Aviceena Dental College), Lahore | Clinical Trial Site | The CSC discussed the application in detail in light of recommendation of inspection panel report. It was decided to reject the case. |