Rapid Alert
CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUG PRODUCT
| DRAP Alert No | No I/S/10-25-92 |
| Action Date | 16th October, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Novartis Pharma (Pakistan) Ltd., Karachi informed DRAP that falsified Femara® 2.5 mg Film Coated Tablet bearing Batch # TELX5 has been identified in the Pakistani market. The reported batch number is not imported, manufactured, or supplied by Novartis Pharma (Pakistan) Ltd., i.e. the genuine registration holder in Pakistan. The packaging falsely uses the Novartis name and branding, but it does not come from the authorized supply chain. |
The product identification details are as under: –
| Risk Statement | In the case of Femara® 2.5 mg Film Coated Tablet (Batch No. TELX5), such falsification may lead to ineffective treatment of hormone-dependent breast cancer, resulting in disease progression or relapse. This poses a serious risk to female cancer patients, particularly post-menopausal women, who depend on this medicine for long-term therapy. This alert applies only to Batch No. TELX5 and does not affect other genuine batches of Femara® available in the market from the authorized registration holder. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified 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 suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers | 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 the above mentioned 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. |