Rapid Alert
| SPURIOUS DYDROGESTERONE TABLETS |
| DRAP Alert No | No I/S/04-26-20 |
| Action Date | 14 April, 2026 |
| 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 (DTL), Government of Punjab has reported that the samples of the following drug products have been declared as “Spurious” under Section 3(z-b)(i) of the Drugs Act, 1976. |
| S# | Product Name | Batch | Manufacturer | Remarks |
| 1 | Dropha Tablets Each Tablet contains Dydrogesterone ……. 10mg | DRP-0011 | Purported to be manufactured under M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, Karachi | Declared Spurious (API not detected, assay 0%, fails identification & dissolution. |
| 2 | Efaston Tablets 10 mg (Dydrogesterone) | 4116 | Purported to be manufactured under M/s Lahore Chemical & Pharmaceutical Works (Private) Limited. 137- Ferozepur Road, Lahore (DML# 000064). | Declared Spurious (API not detected, assay 0%, fails identification & dissolution. |
| 3 | Depasrone Tablets Each Tablet contains Dydrogesterone 10mg | 2648 | Purported to be manufactured under M/s Alpine Laboratories, Plot A-41, S.I.T.E., Karachi | Declared Spurious (API not detected, assay 0%, fails identification & dissolution. |
| Risk Statement | (Dydrogesterone) is commonly prescribed for gynecological and obstetric indications. Use of a spurious product containing no active ingredient may result in therapeutic failure, leading to serious clinical consequences, including unmanaged hormonal conditions, pregnancy-related complications, and risk to maternal health. |
| Action Initiated | The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products. |
| 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. |