Rapid Alert
CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS
| DRAP Alert No | No I/S/08-25-54 |
| Action Date | 11th August, 2025 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | The Drug Regulatory Authority of Pakistan (DRAP) has received information from the Drug, Water and Food Testing Laboratory, Gilgit-Baltistan, indicating that the following purported drug products have been declared ‘spurious’ upon analysis and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under: |
The product identification details are as under: –
Therapeutic Good Affected:-
| S# | Product Name | Batch No. | Purported Manufacturer | Remarks |
| 1 | Missron Tablet Each Tablet contains Dydrogesterone ……. 10mg | 48022 | M/s Fegga Pharmaceutical, F-21/H.P.T.C., S.I.T.E., KARACHI. | Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 2 | Quttefol OD tablets Each film coated tablet contains L-Methyl-Folate (Folic Acid) …………………… 800 mcg Vitamin B12 …….1000 mcg | QL-001 | M/s Adcok Pharmaceuticals Factory 3-km Defense Road Off-Raiwind Road, Lahore | Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as under: – For assay of Vitamin B12, ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976 & For assay of Folic Acid, ‘Substandard’ as defined under sub-section (zz) of Section 3 of the Drugs Act, 1976. |
| 3 | Depasrone Tablets Each Tablet contains Dydrogesterone ……. 10mg | 2406 | M/s Alpine Laboratories, Plot A-41, S.I.T.E., Karachi | Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| 4 | Dropha Tablets Each Tablet contains Dydrogesterone ……. 10mg | DRP-0004 | M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, Karachi | Drug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976. |
| Risk Statement | All the above-mentioned purported drug products have been confirmed as falsified/spurious, as they are manufactured by entities that are neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). These products are being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. Laboratory testing has revealed the absence of active pharmaceutical ingredients in some samples, indicating a complete lack of therapeutic value. The circulation and use of such unregulated products pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered drug products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels. |
| 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. |