Rapid Alert
| DRAP Alert No | No I/S/01-25-08 |
| Action Date | 14th January, 2025 |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · General Public |
| Problem Statement | TM/s Roche Pakistan Limited, Karachi, has notified DRAP, regarding the circulation of counterfeit Ocrevus 300mg/10ml Solution for Injection in the market across Pakistan. Investigation carried out by Roche Global revealed that the genuine product, batch H0041B27, was originally distributed to Turkey in August 2020 and expired on 07-02-2022, while the counterfeit sample displayed expiry date of 05-09-2025. These discrepancies confirmed the product as counterfeit. Details of counterfeit product are as follows: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label claim) | Lab Test Results |
| 1 | Ocrevus Solution for Injection, 300mg/10ml | (Ocrelizumab) | H0041B27 | M/s Roche Diagnostics GmbH, Mannheim, Almanya. | Counterfeit |
| Risk Statement: | Ocrelizumab is a humanized monoclonal antibody used in the treatment of multiple sclerosis. The use of counterfeit productcould result in treatment failure, worsening of the disease, or life threatening consequences. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the mentioned product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product from the circulation. |
| 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 at this link. Any adverse events or quality problems experienced with the use of these products should be reported to the 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.