Rapid Alert
CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS
| DRAP Alert No | No I/S/09-25-67 |
| Action Date | 17th September, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’ as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Purported Manufacturer | Remarks |
| Dytron Tabelt 10mg (Dydrogesterone 10mg) | D1T | Purported to be manufactured by an unlicensed /illegal entity claimed to be Pax Pharmaceuticals Karachi | Spurious (Does not contain active ingredient) | |
| Levontis 375mg (Amoxicillin trihydrate: 250, Clavulanic Acid: 125mg) | LF2 | -do- | Spurious (Does not contain active ingredient) | |
| Levontis 625mg (Amoxicillin trihydrate: 500, Clavulanic Acid: 125mg) | LF2 | -do- | Spurious (Does not contain active ingredient) | |
| Levontis 625mg (Amoxicillin trihydrate: 875, Clavulanic Acid: 125mg) | LF4 | -do- | Spurious (Does not contain active ingredient) | |
| Sulfira suspension (Sucralfate 1g/5ml) | SL6 | -do- | Spurious (Does not contain active ingredient) | |
| Furin 50mcg aerosol spray (Mometasone Furoate 50mcg) | NF4 | -do- | Spurious (Does not contain active ingredient) | |
| Droxel capsule 500mg (Cefadroxil Monohydrate 500mg)) | RC5 | -do- | Spurious (Does not contain active ingredient) | |
| Bromiz tablet (Bromazepam 3mg) | 0007 | Purported to be manufactured by an unlicensed /illegal entity claimed to be Miraz Pharma Kasur (Fictitious firm) | Spurious (Does not contain active ingredient) |
| Risk Statement | All the above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately. |
| Action Initiated | The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/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. |