Rapid Alert
CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUG PRODUCT
| DRAP Alert No | No I/S/10-25-91 |
| 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 | Drug testing Laboratory from Punjab informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’ as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company which has formally disowned the said product. The details of report are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Manufacturer | Remarks |
| 1. | Tablet Myteka 10 mg Each film coated tablet contains: Montelukast Sodium eq. to Montelukast …. 10 mg | 156428 | Purported to be manufactured by: M/s HILTON PHARMA (PVT) LTD. PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI, | Sample is ‘Spurious’ as described under Section 3(zb)(i) & (ii) of Drugs Act 1976. |
| Risk Statement | Use of Myteka Tablet 10 mg (Batch No. 156428), falsely labeled as manufactured by M/s Hilton Pharma (Pvt.) Ltd., has been declared spurious and substandard, as testing revealed no active ingredient and the product is falsified under Section 3(zb)(i)&(ii) of the Drugs Act, 1976. Such falsified medicine poses a serious risk of treatment failure and adverse outcomes, particularly for asthmatic and allergic patients relying on genuine therapy. Consumers and healthcare professionals are advised to immediately stop using the said batch, verify authenticity, and report any suspected productsto DRAP or the concerned Provincial Drug Control authority. |
| 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. |