Rapid Alert
| DRAP Alert No | No I/S/11-24-45 |
| Action Date | 28th November, 2024 |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · General Public |
| Problem Statement | Directorate of Drugs Control (DDC) Punjab and Secretary PQCB Quetta have informed DRAP that samples of various products have been identified as spurious (falsified). Details of test reports are as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label claim) | Lab Test Results |
| 1 | Titan-1000 Injection Reg# 021743 | CeIftriaxone as Ceftriaxone Sodium 1000 mg/vial | 22044 | Purported to be manufactured by Macter International Limited (as per label claim) F-216, S.I.T.E Karachi | “Spurious” and “Substandard” with regards to Assay and Sterility test, |
| Dyrone Film Coated Tablet Reg# 198069 | Dydrogesterone | DR-121 | Purported to be manufactured by Solvay (as per label claim), Plot # 32, Sector,2 Highway Petaro Road Jamshoro Sindh | Spurious | |
| Solverone 10 mg Film Coated Tablet Reg# 068898 | Dydrogesterone | SVN-001 | Purported to be manufactured by Solvay (Fictitious firm), Plot # 32, Sector,2 Highway Petaro Road Jamshoro Sindh | Spurious | |
| Dydowen 10mg Film Coated Tablet Reg# 101507 | Dydrogesterone | 736 | Purported to be manufactured by Weather Folds Pharmaceuticals, Hattar, Pakistan. Manufactured For: Wenovo Pharmaceuticals Taxila | Spurious | |
| DYDRO-FEM 10 mg Film CoatedTablet Reg# 555199 | Dydrogesterone | DFD10/008 DFD10/009 | Purported to be manufactured by Torrent Pharmaceutical, (as per label claim) G-19, Hawkesbay Road SITE, Karachi. | Spurious | |
| M.CEF 30 mL Powder For Oral Suspension Reg# 0432189 | Cefixime as Trihydrate 100 mg/5mL | D00018 | Purported to be manufactured by Dalton Laboratories PVT LTD. (as per label claim) Plot # G-149, Phase L-II Super Highway Road, S.I.T.E. LI Karachi | Spurious | |
| Iodex Ointment Reg# 000394 | Iodine + Methylsalicylate | HIAAC | Purported to be manufactured by GSK Pakistan Karachi | Counterfeit (Falsified) |
| Risk Statement: | The impact of the use of falsified / Substandard products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems. |
| Action Initiated | The field force under the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the mentioned batches from the market. |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available on this link. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available on this link |
| Advice for Consumer | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using these products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. |
All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.