Rapid Alert
CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS
| DRAP Alert No | No I/S/09-25-59 |
| Action Date | 10th 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 |
| 1 | TABLET ONSET-8 (REG # 025989) Each Tablet Contains: ondansetron HCl eq. To ondansetron 8 mg) | 447 | Purported to be manufactured by M/s Pharmedic Laboratories (Pvt) Ltd. (DML # 000228) 16 Km Multan Road Lahore. . | Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. |
| 2 | Capsule Nexum (Reg # 033891) EACH Capsule contains: ENTERIC-COATED PELLETS OF ESOMEPRAZOLE MAGNESIUM TRIHYDRATE EQUIVALENT TO ESOMPERAZOLE 40 MG) | C02085 | Purported to be manufactured by M/s GETZ PHARMА (PVT) LIMITED., PLOT NO. 01, SECTOR 25, KORANGI INDUSTRIAL AREA. KARACHI. | Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. |
| 3 | Capsule Maxflow -D (Reg # 033891) EACH Capsule contains: Extended release pellets of Tamsulosin HCl eq. to Tamsulosin HCl …… 0.4mg | QM375 | Purported to be manufactured by M/s CCL Pharmaceuticals (Pvt.) Ltd. (DML # 000052) 62 Industrial Estate Kot Lakhpat Lahore. | Drug Testing Laboratory, Multan Punjab declared the purported drug product as ‘Spurious with regard to Dutasteride, misbranded with regard to labelling & substandard on basis of dissolution test and assay of tamsulosin HCl’. |
| 4 | Capsule Azomax 250 mg Each Capsule contains: Azithromycin (as di-hydrate) …………………… 250 mg | C3193 | Purported to be manufactured by M/s AGP Ltd. (DML # 000348) Plot No. B-23 Sindh Industrial Trading Estate Karachi. | Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025) |
| 5 | Tablet Rigix Each film coated tablet contains: Cetirizine hydrochloride…….10mg | C3905 C3362 | Purported to be manufactured by M/s AGP Ltd. (DML # 000348) Plot No. B-23 Sindh Industrial Trading Estate Karachi. (Recovered from unauthorized person / paddler) | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. Note: The unit carton bears batch # C3905 while blister bears Batch # C3362. (DDCP Alert No. 171/2025) |
| 6 | Fexet Tablet 120mg Each film coated tablet contains: Fexofenadine hydrochloride. ….120mg | F26018 | Purported to be manufactured by M/s Getz Pharma (Pvt) Limited., Plot No. 01, Sector 25, Korangi Indsustrial Area, Karachi. | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025) |
| 7 | Capsule Zetro 250 mg Each Capsule contains: Azithromycin (as dihydrate) ……..250 mg | 247C21 | Purported to be manufactured by M/s Getz Pharma (Pvt) Limited., 29-30 Sector 27 Korangi Industrial Area Karachi. (Recovered from unauthorized person / paddler) | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 171/2025) |
| 8 | Tablet Duphaston Each film coated tablet contains: Dydrogesterone … 10mg | 241476 | Purported to be manufactured by M/s Highnoon Laboratories Ltd. 17.5 Km Multan Road Lahore. (DML # 000155) (Recovered from unauthorized person / paddler) | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025) |
| 9 | Tablet Danzen DS Each enteric coated tablet contains: Serratiopeptidase 10 mg (20,000 units of Serratiopeptidase) | 3602 | Purported to be manufactured by M/s Helix Pharma (Pvt) Ltd. A/56 SITE Mangopir Karachi. (DML # 000030) (Recovered from unauthorized person / paddler) | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025) |
| 10 | Tablet Terbisil Each Tablet contains: Terbinafine (as HCl) 250 mg | 473 | Purported to be manufactured by M/s Saffron Pharmaceuticals (Pvt) Ltd. (DML # 000616) 19-Km Sheikhupura Road Faisalabad. (Recovered from unauthorized person / paddler) | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025) |
| 11 | Tablet Terbisil Each Tablet contains: Terbinafine (as HCl) 250 mg | 473 | Purported to be manufactured by M/s Helix Pharma (Pvt) Ltd. A/56 SITE Mangopir Karachi. (DML # 000030) (Recovered from unauthorized person / paddler) | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 176/2025) |
| 12 | Tablet Azomax 500 mg Each film coated tablet contains : Azithromycin (as di-hydrate) ……..500 mg | C3670 | Purported to be manufactured by M/s AGP Ltd. (DML # 000348) Plot No. B-23 Sindh Industrial Trading Estate Karachi. (Recovered from unauthorized person / paddler) | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025) |
| 13 | Tablet Prism 10 mg Each tablet contains: Escitalopram oxalate eq. to escitalopram ……. 10 mg | 25PR02 | Purported to be manufactured by M/s Friends Pharma (Pvt) Ltd. (DML # 000531) 31-Km Ferozepur Road Lahore. (Recovered from unauthorized person / paddler) | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025) |
| 14 | Capsule Gabica 300mg Pregabalin l00mg | 427C27 | Purported to be manufactured by M/s Getz Pharma (Pvt) Limited., 29-30 Sector 27 Korangi Industrial Area Karachi. (Recovered from unauthorized person / paddler) | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025) |
| 15 | Tablet Ativan 2 mg Each tablet contains: Lorazepam …… 2 mg | 17C7019 | Purported to be manufactured by M/s Pfizer Pakistan Ltd. B-2, S.I.T.E. Karachi. (Recovered from unauthorized person / paddler) | Drug Testing Laboratory, Punjab declared the purported drug product as ‘Spurious’ as defined under clause (i) of subsection (z-b) of Section 3 of the Drugs Act, 1976. (DDCP Alert No. 178/2025) |
| 16 | Injection ONSET 4 ml ondansetron HCl eq. To ondansetron 2mg/ml) | 829 | Purported to be manufactured by M/s Pharmedic Laboratories (Pvt) Ltd. (DML # 000228) 16 Km Multan Road Lahore. (Recovered from unauthorized person / paddler) . | Drug Testing Laboratory, Rawalpindi Punjab declared the purported drug product as ‘Spurious’ and ‘substandard’ on the basis of assay. (DDCP Alert No. 178/2025) |
| Risk Statement | All the above mentioned purported drug products are confirmed as falsified/spurious/substandard, 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 Low / 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. |