Rapid Alert
| DRAP Alert No | No I/S/12-24-56 |
| Action Date | 10rd December, 2024 |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · General Public |
| Problem Statement | The firm M/s OBS Pharma (Pvt.) Limited, Karachi, has notified DRAP regarding the presence of falsified product “Askinoren Gel” in the market across Pakistan. The primary packaging of the product shows no Batch number and Expiry date. Also, a different brand name Acnoren was mentioned under the heading of dosage. Moreover, there was no Urdu instruction and dosage required as per Labelling Rules, 1986. The details of the identified product are as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label claim) | Lab Test Results |
| 1 | Askinoren Gel | Azelaic Acid 15%) | Nil | M/s Medshare Pharma, Plot No. 04, Special Industrial Zone (APO) Risalpur, KPK. | Spurious |
| Risk Statement: | Azelaic acid is used for the treatment of skin pigmentation and acne. Falsified product may pose a significant threat to public health as the safety and efficacy of such products cannot be established. |
| Action Initiated | The Regulatory Field Force has been directed to take necessary action on the above-mentioned falsified product and is investigating the entire supply chain of this product. The Regulatory Field Force has also been instructed to seize identified falsified products if found on the market. |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available at this link. Any adverse events or quality problems experienced with the use of these products should be reported to the 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 Consumer | 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 these 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.