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Recall Alert: RECALL OF XARELTO 15MG TABLET, BATCH NO. BXK4E11, DUE TO A LABELING ERROR ON SECONDARY PACKAGING

Ahsan Hafiz Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/05-25-43
Action Date20th May, 2025.
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue The firm M/s Bayer Pakistan (Pvt.) Ltd., Karachi has requested for correction of a typographical error identified on the secondary packaging of Xarelto 15 mg Tablets, Batch Number BXK4E11. The error pertains to the incorrect indication of product strength on the outer label, which may lead to potential dosing errors. The details of the product are as under:

Therapeutic Goods (s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Xarelto 15mg Tablet
 
Reg. No. 072549		Each film coated tablet contains:
Rivaroxaban…15mg		BXK4E11M/s Bayer Pakistan Private Limited.,
Plot No. 23, Sector No.22, Korangi Industrial Area, Karachi.
Risk Statement:Incorrect labeling can cause a patient to receive the wrong dosage of a medication. This may result in underdosing, where the medication is not effective, or overdosing, which can lead to harmful side effects or toxicity.
Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of the mentioned batch of product from the market.
– All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying the mentioned batch. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

–Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk.
Advice for Healthcare ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using the product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

    Rapid Alert: CRACKDOWN AGAINST FALSIFIED/SPURIOUS DRUGS

    Ahsan Hafiz Recall Alerts
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    Rapid Alert

    DRAP Alert NoNo  I/S/05-25-42
    Action Date19th May, 2025
    Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
    2. Healthcare Professionals
    3. Pharmacies and medical stores
    Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The details of the report are as under:

    The product identification details are as under: –

    Therapeutic Good Affected:-

    Product Batch No Manufacturer Name
    (as per label)     		Remarks
    Cefim Capsule 400mg

    Each capsule contains:
    Cefixime as trihydrate USP…400mg    		150994M/s Hilton Pharma (Pvt.) Ltd.,
    Plot No. 13-14, Sector 15, Korangi Industrial Area, Karachi.    		‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976.
    Acefyl Cough Syrup 125mL

    Each 5ml contains:
    Acefylline Piperazine……45mg
    Diphenhydramine HCL…….8mg    		ACG753M/s Nabiqasim Industries (Pvt.) Ltd.,.,
    17/24, Korangi Industrial Area, Karachi.    		‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976.
    DROPHA-10 Tablet
     
    Each film coated tablet contains:
    Dydrogesterone…..10mg    		DRP-0012M/s Himax Pharmaceutical.,
    Plot No. 445, Korangi Industrial Area, Karachi.    		‘Spurious’ as per Section 3(z-b) (i)of the Drugs Act, 1976.
    Dydrocare 10mg Tablet

    Each film coated tablet contains:
    Dydrogesterone…..10mg    		DC-0003-YM/s Carryfor Pharmaceuticals (Pvt.) Ltd.,
    Plot No. E-81, North Western Industrial Zone, Port Qasim, Karachi.    		‘Spurious’ as per Section 3(z-b) (i)of the Drugs Act, 1976.
    Dydroplax 10mg Tablet

    Each film coated tablet contains:
    Dydrogesterone…..10mg    		DDP-0491-XM/s Carryfor Pharmaceuticals (Pvt.) Ltd.,
    Plot No. E-81, North Western Industrial Zone, Port Qasim, Karachi.    		‘Spurious’ as per Section 3(z-b) (i)of the Drugs Act, 1976.

    Risk StatementFalsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
    Action InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.

    Stakeholders are invited to comment on Draft Guidelines on Emergency Use Authorization by 06th June, 2025

    Mughees Mudassir Drugs, General

    Draft Guidelines on Emergency Use Authorization

    The Drug Regulatory Authority of Pakistan (DRAP) has developed a draft guideline outlining the regulatory framework for granting Emergency Use Authorization (EUA) of medicinal products during a declared Public Health Emergency (PHE). This guideline aims to facilitate timely access to critical medicines, vaccines, or diagnostics when no approved alternatives are available, ensuring public health protection while maintaining rigorous safety and efficacy standards.

    Key Highlights of the EUA Guideline

    • Legal Basis: EUA is granted under the Drugs Act, 1976 and Drug (Licensing, Registering & Advertising) Rules, 1976, empowering DRAP to authorize unregistered products during emergencies.
    • Risk-Benefit Assessment: Authorization considers whether the potential benefits outweigh risks in diagnosing, treating, or preventing life-threatening conditions.
    • Scope: Applies to emergencies involving threats to public health, safety, or national security (e.g., pandemics, bioterrorism).
    • Alignment with Existing Guidelines: Should be read alongside DRAP’s Guidance Documents for Registration of Pharmaceutical & Biological Products.

    Call for Stakeholder Input

    DRAP invites healthcare professionals, pharmaceutical manufacturers, researchers, policymakers, and the public to review the draft guideline and provide constructive feedback. Your expertise will ensure the framework is robust, transparent, and aligned with international best practices.

    How to Submit Comments

    1. Download the Draft Guideline: https://www.dra.gov.pk/wp-content/uploads/2025/05/DRAP-EUA-Guideline-2025.docx
    2. Submit Feedback: Email comments to muneeb.cheema∂drap.gov.pk by 06th June, 2025.

    Deadline for Feedback: 06th June, 2025

    Comments are invited on revision of Guidelines on Inspection of Good Clinical Practices for Clinical Trials

    Abdul Qadir Clinical Trials

    The Drug Regulatory Authority of Pakistan (DRAP) is planning to revise its guideline for the conduct of Good Clinical Practice (GCP) inspection and reporting. The current guideline was issued in Maech-2024 and provides the procedure and criteria for GCP inspections of clinical trials regulated by DRAP.

    The revision aims to update the guideline in accordance with the latest international standards and best practices, as well as to address the feedback and suggestions received from the stakeholders. The revised guideline will cover the following aspects:

    • The objectives and scope of GCP inspections
    • The preparation and planning of GCP inspections
    • The conduct and documentation of GCP inspections
    • The follow-up and closure of GCP inspections

    The revised guidelines are open for public comments until June 05, 2025. DRAP invites all the relevant stakeholders, such as pharmaceutical companies, research institutions, clinical trial organizations, health professionals, patient groups, and civil society organizations, to review the revised guidelines and provide their feedback and suggestions. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to shafqat.hussain∂dra.gov.pk with copy to dir.ps∂dra.gov.pk or can be posted at following mailing address: Assistant Director (Clinical Research), Pharmacy Services Division, Drug Regulatory Authority of Pakistan, DRAP-NCLB Building, Prime Minister’s Health Complex, Park Road, Chak Shahzad, Islamabad, Pakistan. DRAP appreciates your participation and contribution to this consultation process. Your comments and inputs will help us to improve the quality and effectiveness of our GCP inspection and reporting system

    Draft-GCP-Inspection-Guidelines-3rd-Edition-21-05-25-Download

    Stakeholders Comments are invited on revision of Guidelines for Conduct of Clinical Research in Pakistan

    Abdul Qadir Clinical Trials, Uncategorized

    The Drug Regulatory Authority of Pakistan (DRAP) is revising Guidelines on Conduct of Clinical Trials in Pakistan with the aim to ensure the safety, quality, and efficacy of investigational products in clinical trials, as well as the ethical conduct and oversight of clinical research in Pakistan.

    The revised guidelines cover various aspects of clinical trial activities, such as:

    • The regulatory framework and approval process for clinical trials in Pakistan
    • The roles and responsibilities of various stakeholders involved in clinical trial activities, such as DRAP, National Bio Ethics Committee, sponsors, investigators, and pharmaceutical associations
    • The requirements and procedures for obtaining informed consent, protecting the rights and welfare of trial participants, and reporting adverse events and serious adverse events
    • The standards and principles for designing, conducting, monitoring, recording, analyzing, and reporting clinical trials
    • The good clinical practice (GCP) requirements for clinical trial materials and investigational products
    • The data management and quality assurance systems for clinical trial data and documents
    • The post-trial obligations and follow-up measures for clinical trial sponsors and investigators

    The revised guidelines are based on the best regulatory practices as per the International Council for Harmonisation (ICH) guidelines, and the World Health Organization (WHO) guidelines.

    The revised guidelines are open for public comments until June 05, 2025. DRAP invites all the relevant stakeholders, such as pharmaceutical companies, research institutions, clinical trial organizations, health professionals, patient groups, and civil society organizations, to review the revised guidelines and provide their feedback and suggestions. Stakeholders can submit their comments and suggestions using prescribed format (click here to visit how to submit comments) via email to shafqat.hussain∂dra.gov.pk or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, PM health Complex, Park Road, Islamabad.

    DRAP appreciates the cooperation and contribution of all the stakeholders in the development and improvement of the guidelines on conduct of clinical trials in Pakistan. DRAP hopes that the revised guidelines will facilitate and promote the conduct of high-quality, ethical, and reliable clinical trials in Pakistan, and ultimately benefit the public health and well-being of the people of Pakistan.

    Draft-Guidelines-to-Conduct-of-Clinical-Research-in-Pakistan-12-05-2025-3rd-Revision-2Download

    Rapid Alert: CRACKDOWN AGAINST FALSIFIED/SPURIOUS DRUGS

    Ahsan Hafiz Recall Alerts
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    Rapid Alert

    DRAP Alert NoNo  I/S/05-25-41
    Action Date13th May, 2025
    Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
    2. Healthcare Professionals
    3. Pharmacies and medical stores
    Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The details of the report are as under:

    The product identification details are as under: –

    Therapeutic Good Affected:-

    Product Batch No Manufacturer Name
    (as per label)     		Remarks
    Duphaston Tablet

    Each film coated tablet contains:
    Dydrogesterone…10mg    		241476M/s Highnoon Laboratories Ltd.,
    17.5 Km, Multan Road, Lahore.    		‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976.
    Calamox Tablet
     
    Each film coated tablet contains:
    Amoxicillin Trihydrate eq. to Amoxicillin….875mg
    Clavulanate potassium eq. to Clavulanic acid…125mg    		C240712M/s Bosch Pharmaceuticals (Pvt.) Ltd.,
    221-223, Sector 23, Korangi Industrial Area, Karachi.    		‘Spurious’ as per Section 3(z-b) (i)and (ii)of the Drugs Act, 1976.
    Zamclo Tablet
     
    Each enteric coated tablet contains:
    Diclofenac sodium…..50mg    		ZC-0023M/s Zamko Pharmaceuticals (Pvt) Ltd.,
    641-A, Sundar Industrial Estate, Lahore.    		‘Spurious’ as per Section 3(z-b) (ii)of the Drugs Act, 1976.

    Risk StatementFalsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
    Action InitiatedThe 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 ProfessionalsDRAP 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 ConsumersConsumers 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.