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Month: February 2024

Recall Alert: Drug Product; DXL 60mg Capsule (Batch # 23136) by M/s. Titlis Pharma Lahore

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo II/S/02-24-09
Action Date27th February, 2024
Target Audience·         National Regulatory Field Force.
·         Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
·         Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
Problem / Issue The Secretary, PQCB Baluchistan has reported that samples of “DXL 60mg Capsule” bearing Batch No. 23136 manufactured by M/s. M/s. Titlis Pharma, 528-A Sundar Industrial Estate, Raiwind Road, Lahore. has been declared as “Substandard” by Government Analyst, Drug Testing Laboratory, Baluchistan.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
DXL 60mg Capsule
 
Reg.No 097679		DexlansoprazoleBatch No.  2336
 
Mfg. Date: 03-23
Exp. date: 03-25		M/s. Titlis Pharma,
528-A Sundar Industrial Estate,
Raiwind Road, Lahore.
Risk Statement:The use of substandard dexlansoprazole capsules may lead to untoward adverse drug reactions and may generate an unpredictable response based on individual variability.
Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s).

-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 through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
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 this 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.

    Recall Alert: Drug Product; Mencobal 500mcg Injection (Batch # 082) by M/s. Treat Pharmaceutical Industry (Pvt.) Ltd.,Bannu.

    Asad Ullah Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/02-24-08
    Action Date27th February, 2024
    Target Audience·         National Regulatory Field Force.
    ·         Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    ·         Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
    Problem / Issue The Secretary, PQCB Baluchistan has reported that samples of Mencobal Injection bearing Batch No. 082 manufactured by M/s. Treat Pharmaceutical Industry (Pvt.) Ltd., Bannu, has been declared as “Substandard” by Government Analyst, Drug Testing Laboratory, Baluchistan.

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch No Manufacturer
    Mencobal 500mcg Injection
     
    Reg.No 075537    		MecobalaminBatch No. 082
     
    Mfg. Date: 06-23
    Exp. date: 06-25    		M/s. Treat Pharmaceutical Industry
    (Pvt.) Ltd., A-37 Small Industrial Estate,
    Township, Kohat Road, Bannu.
    Risk Statement:The impact of the use of substandard injectable preparations can be serious as it may lead to infection and others adverse reactions or even sepsis.
    Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s).

    -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 through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.

    -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
    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 this 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.

      Recall Alert: Drug Product; SN ZOR 200mg/5mL Suspension (Batch # 342) by M/s. S.N.B Pharma (Pvt) Ltd. Peshwar

      Asad Ullah Recall Alerts

      Recall Alert

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      DRAP Alert NoNo II/S/02-24-10
      Action Date26th February, 2024
      Target Audience·         National Regulatory Field Force.
      ·         Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      ·         Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
      Problem / Issue The Federal Government Analyst, CDL Karachi has declared the Batch No. 342 of product “SN Zor 200mg/5mL suspension for oral use, manufactured by S.N.B Pharma (Pvt) Ltd. Peshawar as Substandard for non-complying assay result.

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch No Manufacturer
      SN Zor 200mg/5mL Suspension
       
      Reg No. 074547      		AzithromycinBatch No. 342

      Mfg. Date: 08-23
      Exp. date: 08-25      		M/s. S.N.B Pharma
      (Pvt) Ltd. Peshawar
      Risk Statement:The impact of the use of substandard powder for oral suspension on the basis of low assay may cause sub-optimal effects and therapeutic failure.
      Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s).

      -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 through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.

      -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
      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 this 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.

        Decisions of 64th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

        Asad Ullah Medical Devices Board

        The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 64th meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.

        Letter-of-Deferred-Products-M-64Download

        Important Notice to INGOs, NGOs, Hospitals and Government Programs/Departments Importers of Donated Drugs in Pakistan

        Asad Ullah Drugs, General

        The Drug Regulatory Authority of Pakistan (DRAP) and the Pakistan Single Window (PSW) have implemented an automated clearance system for the importation of donated drugs in Pakistan. This system aims to optimize and expedite the efficiency of the pharmaceutical supply chain in Pakistan and ensure a seamless and transparent delivery of donated drugs.

        PSW Subscription Required for Donated Drugs Importation in Pakistan

        To participate in this system, all registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs importation need to acquire their PSW Subscription promptly.

        The PSW Subscription is a pivotal step in ensuring a smooth and sustainable pharmaceutical supply chain in Pakistan. Your subscription significantly contributes to the optimization of drug distribution, allowing us to collectively make a more substantial impact on public health.

        How to Subscribe in 6 Easy Steps:

        • Visit the PSW website to access detailed instructions, user manuals, and demo videos.
        • Follow the straightforward subscription process and complete your subscription efficiently.
        • If you have any questions or require assistance during the subscription process, contact the PSW Support team at 021-111-111-779 or reach out via email at support∂psw.gov.pk.
        DRAP-PSW-Online-module-for-donation-medicineDownload

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

        Asad Ullah Clinical Trials, Drugs

        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 2022 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

        DRAP invites all interested parties, including sponsors, investigators, ethics committees, contract research organizations, and other relevant entities, to provide their comments and inputs on the revision of the guideline. 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-Final (1)Download

        DRAP invited Stakeholders Comments on revision of Guidelines on Recall of Defective Therapeutic Goods

        Asad Ullah Drugs, Regulatory Updates

        The Drug Regulatory Authority of Pakistan (DRAP) is revising the Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods, which were first published in 2021. The revision is based on the feedback from stakeholders and the recommendations from the World Health Organization (WHO).

        The guidelines provide a comprehensive framework for reporting, investigating, and recalling suspected defective therapeutic goods products and applies to the therapeutic goods industry and supply chain, healthcare professionals, patients, sponsors of clinical trials, and regulatory staff. The guidelines aim to provide recommendations and explain the procedures to be adopted by the DRAP and the Pharmaceutical Industry for the effective removal of defective therapeutic goods from the market that may cause harm to the consumer and to safeguard public health.

        By adhering to these guidelines, the licensees and the DRAP can ensure a timely, coordinated, and transparent response to any defective therapeutic goods incidents, and thus protect the health and safety of the public and the animals.

        The main objectives of the revision are to:

        • Update the procedures for recalls and related actions for defective therapeutic goods
        • Adopt a uniform and consistent approach to conducting recalls in Pakistan
        • Incorporate the best practices and lessons learned from the consultative workshop on recalls and rapid alerts held by DRAP
        • Enhance the communication and coordination among the manufacturers, importers, suppliers, and DRAP in conducting recalls
        • Strengthen the monitoring and evaluation of the recall outcomes and follow-up actions

        We invite all stakeholders to review the draft revised guidelines and provide us with your comments and suggestions . This draft guideline is available for comments from 21-02-2024. 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 sanaullah.babar∂dra.gov.pk with copy to mahvash.ansari∂dra.gov.pk or can be posted at following mailing address: Deputy Director, Quality Assurance & Laboratory Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

        Draft Recall Guidelines (Edition 2) V1 –Download

        Stakeholders are invited to submit their comments on Draft Guidance on Establishment of Pharmaceutical Unit and Post License Changes (2nd edition)

        Mughees Mudassir Drugs, Licensing and Inspections ,

        The Drug Regulatory Authority of Pakistan (DRAP) is inviting stakeholder comments on the revised guidance document: “Establishment of Pharmaceutical Unit and Post License Changes”. This document aims to simplify and clarify the regulatory procedures for applicants and firms seeking to acquire, renew, or modify their Drug Manufacturing Licenses (DMLs).

        Features of Revised Edition of the Guidance Document

        This document provides a clear and concise overview of the entire licensing process, from initial application to post-license modifications.

        The guidance document outlines the steps involved in obtaining a DML, including site selection, application forms, fee payment, and inspections. This aims to make the process more efficient and transparent for applicants.

        Who Benefits

        Applicants: This guideline serves as a valuable resource for pharmaceutical companies, entrepreneurs, and individuals seeking to establish or expand their drug manufacturing operations in Pakistan.

        Firms: Existing DML holders can utilize this document to understand their responsibilities and procedures for post-license changes and renewals.

        Investors: The streamlined process outlined in the guideline can create a more attractive investment climate for the pharmaceutical industry in Pakistan.

        To access the full DRAP guidance document, please Click on “Establishment of Pharmaceutical Unit and Post License Changes”.

        The revised guidelines are open for public comments until March 7, 2024. DRAP invites all the relevant stakeholders, such as pharmaceutical companies 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 dir.lic∂dra.gov.pk or can be posted at mailing address, Director, Division of Drug Licensing, 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.

        Establishment of pharmaceutical units and post licensure changesDownload

        DRAP added New features in eAPP system enabling Online Submission for all types of Registration Applications of Drug Products

        Ijaz Mustafa Drugs, General

        The Drug Regulatory Authority of Pakistan (DRAP) added a new e-service for online regulatory data submission for registration/marketing authorization of human drugs for local manufacturing, import and export. This e-service complements the existing one for licensing operations of all pharmaceutical and biological manufacturers, which are both accessible through the same platform. This e-service is part of the transformation strategy of the Drug Regulatory Authority of Pakistan, which aims to ensure the quality, safety and efficacy of therapeutic goods in Pakistan.

        The e-service requires applicants to submit their data in a standardized format, as specified in the following type of submission:

        • Registration of Drugs on Form-5F for human Use.
        • Registration of Drugs on Form-5 & Form 5A for Veterinary Use.
        • Application for Post Registration Variations.
        • Renewal for Registration of Drugs

        The new e-service allows applicants to submit their data electronically through the eAPP portal, which can be accessed after registering an account with DRAP. The e-service offers several benefits, such as:

        • Faster and easier data submission and processing
        • Reduced paper work and redundancy
        • Increased transparency and visibility

        This new e-service will facilitate the licensing and registration process and improve the regulatory system in Pakistan. DRAP will reach out to applicants in assisting application submission on this new eService.

        We welcome your feedback and suggestions on how to improve our services. Please contact us at info∂dra.gov.pk or +92 51 9260 500 for any queries or assistance.

        We hope that these new features will further enhance the efficiency and convenience of our e-service and facilitate the development and availability of quality therapeutic goods in Pakistan.

        E-APP-Circular-DRAPDownload