Year: 2026
Minutes of 360th Meeting of the Registration Board (07 July 2026)
Minutes of 359th Meeting of the Registration Board (09 June 2026)
Mandatory Requirement of Auditor’s Report Bearing UDIN for Issuance of Nothing Due Certificate (NDC) in Respect of Central Research Fund
Intimation Regarding Capacity Building and Technical Awareness Session on 2-D barcode and Serialization Implementation
Consultative Meeting on Refurbished Medical Device Regulations 2026
Decisions of 128th,129th,131st,133rd,134th Meeting of The Medical Device Board (MDB)
Draft Medical Devices(Refurbishment) Regulations, 2026 for comments of the stakeholders.
38. Rapid Alert – Falsified JAKAVI® (Ruxolitinib) Tablets
Rapid Alert
| Falsified JAKAVI® (Ruxolitinib) Tablets Identified in the WHO Eastern Mediterranean and European Regions |
| DRAP Alert No | No I/S/07-26-38 |
| Action Date | 16 July, 2026 |
| Target Audience | National Regulatory Field Force of DRAP and Provincial Drug Control Departments. Healthcare Professionals (Oncologists, Hematologists, Pharmacists & Nurses). Hospitals and Oncology Treatment Centres. General Public. |
| Problem Statement | The Drug Regulatory Authority of Pakistan (DRAP) has received WHO Medical Product Alert No. 2/2026 regarding falsified JAKAVI® (ruxolitinib) tablets identified in the WHO Eastern Mediterranean and European Regions. The falsified products were detected in the Islamic Republic of Iran, Türkiye, and the Russian Federation after being illicitly sold through online platforms and, in at least one instance, supplied through a pharmacy. The genuine manufacturer, Novartis Pharma AG, has confirmed that the following batch numbers are not genuine. Any JAKAVI® product bearing these batch numbers should be considered falsified and should not be used. |
| S# | Name of Product | Batch No. | Manufacturer Details | Remarks |
| 1 | JAKAVI® (Ruxolitinib) Tablets 20 mg | AVT50 | Manufacturer: Novartis Pharma AG, Lichtstrasse 35, CH-4056 Basel, Switzerland | Falsified Product |
| 2 | JAKAVI® (Ruxolitinib) Tablets 15 mg | FNR06 | Manufacturer: Novartis Pharma AG, Lichtstrasse 35, CH-4056 Basel, Switzerland | |
| 3 | JAKAVI® (Ruxolitinib) Tablets 15 mg | SGL04 | Manufacturer: Novartis Pharma AG, Lichtstrasse 35, CH-4056 Basel, Switzerland |
| Risk Statement | JAKAVI® (ruxolitinib) is indicated for the treatment of myelofibrosis, polycythaemia vera, and graft-versus-host disease following stem cell transplantation. The identified products are falsified medical products. Novartis has confirmed that the above-mentioned batch numbers are not valid. Laboratory analysis of a sample from batch AVT50 confirmed the absence of the declared active ingredient (ruxolitinib). Additionally, visual discrepancies were identified in the packaging, including the absence of batch numbers on blister strips of certain falsified batches. Use of these falsified products may result in treatment failure, disease progression, increased morbidity, and potentially life-threatening outcomes. Patients receiving JAKAVI® often have compromised immune systems, making them particularly vulnerable to ineffective or falsified medicines. |
| 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. |
37. Rapid Alert – Falsified DARZALEX (Daratumumab) Injection
Rapid Alert
| Falsified DARZALEX (Daratumumab) Injection Identified in WHO Regions of the Americas and South-East Asia |
| DRAP Alert No | No I/S/07-26-37 |
| Action Date | 16 July, 2026 |
| Target Audience | National Regulatory Field Force of DRAP and Provincial Drug Control Departments. Healthcare Professionals (Oncologists, Hematologists, Pharmacists & Nurses). Hospitals and Oncology Treatment Centres. General Public. |
| Problem Statement | The Drug Regulatory Authority of Pakistan (DRAP) has received a Medical Product Alert No. 3/2026 issued by the World Health Organization (WHO) regarding falsified DARZALEX (Daratumumab) Injection identified in the WHO Regions of the Americas and South-East Asia. The falsified products were detected in Maldives and Mexico after being supplied through non-authorized distributors, with at least one report indicating supply to hospitals. The genuine manufacturer, JANSSEN, has confirmed that the following batch numbers are not valid and any DARZALEX product bearing these batch numbers should be considered falsified. |
| S# | Name of Product | Batch No. | Stated Manufacturer | Remarks |
| 1 | DARZALEX (Daratumumab) Injection 400 mg/20 mL | STV1K01 | Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. | Falsified Product |
| 2 | DARZALEX (Daratumumab) Injection 100 mg/5 mL | MYS7381 | Falsified Product |
| Risk Statement | DARZALEX (daratumumab) is a monoclonal antibody indicated for the treatment of multiple myeloma and amyloid light-chain (AL) amyloidosis. No laboratory testing has been performed on the falsified products and their identity, composition, quality, and sterility remain unknown. These products may contain no active ingredient, incorrect ingredients, or harmful substances, making them ineffective or potentially dangerous. WHO has also reported the presence of visible particulate matter in one falsified batch (STV1K01), indicating a potential risk of contamination. Use of these products may result in treatment failure, disease progression, infections, injection-related complications, increased morbidity, and potentially life-threatening outcomes. |
| 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. |