Rapid Alert
CRACKDOWN AGAINST FALSIFIED / SPURIOUS – CIALIS®
| DRAP Alert No | No I/S/10-25-96 |
| Action Date | 20th 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 | Central Drugs Laboratory certified that Cialis® 20 mg Tablet bearing Batch # 24576 purported to be manufactured by M/s Eli Lilly and Company Limited, & Cialis® 20 mg Gold (Batch # MAL 19990546AG) purported to be manufactured by M/s Lilly ICOS, USA are “Falsified & spurious” identified in the Pakistani market. The reported Brands & batch numbers are not imported, manufactured, or supplied by the manufacturers mentioned on the label. The packaging falsely uses the name and branding, but it does not come from any authorized supply chain. |
The product identification details are as under: –
| Risk Statement | These falsified and spurious products pose a significant health risk to the public. Since the brands & batches have not been imported or supplied through any authorized or traceable source, its actual composition, safety, and efficacy remain unknown. Individuals who may have purchased this product from unauthorized medical stores, online platforms, or informal supply chains are at particular risk of exposure to unverified and potentially harmful ingredients. Use of such falsified medicine can lead to serious adverse health effects, therapeutic failure, or toxic reactions, especially among patients with cardiovascular or metabolic conditions. |
| 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. |