Rapid Alert
| DRAP Alert No | No I/S/05-25-41 |
| Action Date | 13th May, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Directorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The details of the report are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| Product | Batch No | Manufacturer Name (as per label) | Remarks |
| Duphaston Tablet Each film coated tablet contains: Dydrogesterone…10mg | 241476 | M/s Highnoon Laboratories Ltd., 17.5 Km, Multan Road, Lahore. | ‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976. |
| Calamox Tablet Each film coated tablet contains: Amoxicillin Trihydrate eq. to Amoxicillin….875mg Clavulanate potassium eq. to Clavulanic acid…125mg | C240712 | M/s Bosch Pharmaceuticals (Pvt.) Ltd., 221-223, Sector 23, Korangi Industrial Area, Karachi. | ‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976. |
| Zamclo Tablet Each enteric coated tablet contains: Diclofenac sodium…..50mg | ZC-0023 | M/s Zamko Pharmaceuticals (Pvt) Ltd., 641-A, Sundar Industrial Estate, Lahore. | ‘Spurious’ as per Section 3(z-b) (ii)of the Drugs Act, 1976. |
| Risk Statement | Falsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences. |
| 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. |