Rapid Alert
CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED APHRODISIAC DRUG PRODUCTS
| DRAP Alert No | No I/S/10-25-98 |
| Action Date | 22 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 (CDL), Karachi informed that the following drug product have been declared ‘spurious/falsified/unregistered’ upon analysis and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under: |
| S# | Product Name | Batch No. | Manufacturer | Remarks |
| 1. | JUMBO 150mg Capsules Each Capsule contains: Sildenafil Citrate ……. 150mg | JUC-05 | M/s Combitic Global Caplet Pvt. Ltd. India | ‘Unregistered (Falsified)’ drug product |
| 2. | COBRA 150 Tablets Each tablet contains: Sildenafil Citrate ……. 150mg | CBT289 | M/s Combitic Global Caplet Pvt. Ltd. India | ‘Unregistered (Falsified)’ drug product |
| 3. | BLACK COBRA 125 Tablets Each tablet contains: Sildenafil Citrate ……. 125mg | BOB96 | M/s Combitic Global Caplet Pvt. Ltd. India | ‘Unregistered (Falsified)’ drug product |
| 4. | PENEGRA 100 Tablets Each tablet contains: Sildenafil Citrate ……. 100mg | G400016 | M/s Zydus Lifesciences Limited, India. | ‘Unregistered (Falsified)’ drug product |
| 5. | BLACK COBRA 250 Tablets Each tablet contains: Sildenafil Citrate ……. 250mg | BOR-31 | M/s Combitic Global, India. | ‘Unregistered (Falsified)’ drug product |
| 6. | Super CIALIS 5mg Tablets Each tablet contains: Sildenafil Citrate ……. 250mg | 205-113 | M/s HAB Pharmaceuticals & Research Limited, India. | ‘Unregistered (Falsified)’ drug product |
| 7. | KNIGHT RIDER DELAY SPRAY Contains Lidocaine | S-A0110 | M/s Royal Herbal Ent. Co. Karachi. | ‘Unregistered (Falsified)’ drug product |
| 8. | TOKO-D3 Cream Contains Lidocaine | 62051 | M/s Mehran Homoeo Pharma, Mangora Swat. | ‘Unregistered (Falsified)’ drug product |
| 9. | UD Cream Contains Lidocaine | 35924 | M/s Mehran Homoeo Pharma, Mangora Swat. | ‘Unregistered (Falsified)’ drug product |
The product identification details are as under: –
| Risk Statement | The above-mentioned products have been declared Unregistered and Falsified as they are not confirmed to have been manufactured, imported, or distributed through any supply chain duly authorized or licensed by the Drug Regulatory Authority of Pakistan (DRAP) or the respective Provincial Governments. The origin, composition, and quality of these products remain unverified; therefore, their safety and efficacy cannot be assured. The unregulated presence of such aphrodisiac preparations containing Sildenafil Citrate and Lidocaine poses significant public health risks, including potential cardiovascular complications, neurological adverse effects, and misuse in vulnerable populations. The continued sale or use of these products outside the legal distribution framework represents a serious threat to consumer safety and undermines regulatory control mechanisms intended to ensure the availability of genuine and quality-assured therapeutic goods. |
| 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. |