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Recall Alert: Drug Product; Kemygyl 200mg/5mL oral Suspension (Batch # M-319) by M/s. Alkemy Pharmaceutical Laboratories (Pvt) Ltd, Hyderabad

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo II/S/08-23-31
Action Date08th Sep, 2023
Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
· Procurement Officers at Hospitals and Healthcare Institutions.
· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue The Provincial Government Analyst/Director, Drug Testing Laboratory, Karachi has declared the Batch No. M-319 of Kemygyl Suspension as of substandard quality sampled by Provincial Inspector of Drugs Jamshoro.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Kemygyl Suspension 200mg/5ml

MetronidazoleBatch No M-3019
 
Mfg date 09.2022
 
Exp date 08.2024		Ms. Alkemy Pharmaceutical Laboratories (Pvt.) Ltd, Hyderabad.
Risk Statement:Metronidazole Oral Suspension is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or suspected. Use of substandard products may lead to suboptimal to no-therapeutic effects and may contribute to drug resistance, and can also intensify/exacerbate the existing bacterial infection.
Action Initiated-The manufacturer has been directed 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) should also 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.

    Rapid Alert; Drug Product: Falsified Defitelio 80mg/mL Injection identified in Neighboring Countries

    Asad Ullah Recall Alerts
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    Rapid Alert

    Falsified Defitelio 80mg/mL Injection
    (Updated form WHO)

    DRAP Alert NoNo  I/S/09-23-44
    Action DateSeptember 08, 2023
    Target Audience1. Regulatory Field Force.
    2. Healthcare Professionals – Physicians, Pharmacists, and Nurses.
    3. General Public.
    Problem StatementWHO has informed regarding the presence of a falsified batch of DEFITELIO (defibrotide sodium) Lot No. 20G20A detected in India (April 2023) and Türkiye (July 2023) and was supplied outside of regulated and authorized channels. This product is not registered in Pakistan however, due to its detection in the neighboring countries, it is highly likely that this product can infiltrate the Pakistani market.
    DEFITELIO (defibrotide) is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in hematopoietic stem-cell transplantation (HSCT) therapy. It is indicated for adults, adolescents, children and infants over 1 month of age. VOD is a condition in which the veins in the liver become blocked and stops the liver from working correctly.
    The genuine manufacturer of DEFITELIO has confirmed that the product referenced in this Alert is falsified. The genuine manufacturer has advised that:
    ·         Genuine DEFITELIO with Lot 20G20A was packaged in German/Austrian packaging.
    ·         The falsified products instead are in UK/Ireland packaging.
    ·         The stated expiry date is falsified and does not comply with the registered shelf life.
    ·         The stated serial number is not associated with batch 20G20A.
    ·         DEFITELIO does not have marketing authorization in India and Türkiye.

    Therapeutic Goods Affected:-

    SrProduct NameCompositionBatch/Lot #Mfg. DateExp. DateManufactured by
    (as stated on label)
    1DEFITELIO 80 mg/mL concentrate for solution for infusion
    		Defibrotide20G20A—Aug-2024Gentium Srl
    (UK/ Ireland packaging)
    Threats to Public HealthThe use of falsified DEFITELIO will result in the ineffective treatment of patients and may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances. Moreover, the safety, sterility, and quality of the falsified products referenced in this alert are also unknown.
    Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. Since this product is not registered with DRAP, it is not permitted to be stocked or sold in pharmacies or other retail outlets. However, it is crucial for all healthcare professionals, including pharmacists and chemists, to check their stock immediately and stop the distribution or supply of this product if it is found. Information related to the supplier of this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product.
    Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.

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

    -Please click here for further information on problem reporting to DRAP.
    Advice for ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.

    Pictures of Defiiteli 80mg/mL injection identified as falsified Product

    Pictures of Falsified Defitelio 80mg/mL Injection identified in Türkiye

    Recall Alert: Drug Product; Plivil 25mg Injection (Batch # 847) by M/s. Pliva Pakistan, (Pvt) Ltd, Baluchistan

    Asad Ullah Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/08-23-22
    Action Date06th Sep, 2023
    Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
    · Procurement Officers at Hospitals and Healthcare Institutions.
    · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
    Problem / Issue The Secretary, PQCB Baluchistan has informed DRAP that samples of Plivil Injection (Batch No. 847) manufactured by M/s. Pliva Pakistan (Pvt.) Ltd., B-77, Lasbella Industrial Estate, Baluchistan, has been analyzed by the Government Analyst, Drug Testing Laboratory (DTL), Baluchistan, Quetta and declared as Adulterated and misbranded based on analysis.

    Therapeutic Goods Affected:-

    Product NamesCompositionBatch No Manufacturer
    Plivil 25mg/ml Injection

    Reg No 021513    		Pheniramine Maleate
    25mg/ml    		Batch No 847
     
    Mfg date 02.2023
     
    Exp date 02.2025    		M/s. Pliva Pakistan (Pvt.) Ltd., Baluchistan.
    Risk Statement:Presence of foreign particles may interact within the injectable solution and may change the chemical consistency of the solution. If injected, they can cause inflammation, tissue damage, or allergic or immunogenic reactions. Additionally, unclear labels on the drug products may create difficulty in reading and understanding of drugs and may lead to medication errors such as taking the wrong medication or the wrong dose.
    Action Initiated-The manufacturer has been directed 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) should also 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 59th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

      Asad Ullah Medical Devices Board

      The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 59th meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.

      Defered-Letter-of-59th-Meeting-of-MDBDownload

      The National Pharmacovigilance Center, DRAP urge the manufacturers and importers to nominate Pharmacovigilance Officer to ensure safe use of drugs.

      Ijaz Mustafa Drugs, General, Notifications, Pharmacovigilance , , , , , ,

      Pharmacovigilance is the science and practice of monitoring the safety and efficacy of drugs, both before and after they are marketed. It is a vital aspect of ensuring public health and patient safety, as well as complying with regulatory requirements and ethical standards.

      Pharmacovigilance officers are professionals who are responsible for collecting, analyzing, and reporting data on adverse drug reactions, drug interactions, and other potential safety issues. They also conduct risk assessments, implement risk management plans, and communicate with health authorities, health professionals, and patients.

      The National Pharmacovigilance Centre at Drug Regulatory Authority of Pakistan urges the pharma industry to nominate or appoint pharmacovigilance officers for their products, as this will ensure the highest standards of quality and safety for their customers and patients. Pharmacovigilance is not only a legal obligation but also a social responsibility. Focusing on pharmacovigilance can enhance reputation, credibility, and competitiveness of a product in the global market.

      According to the Pharmacovigilance Rules, 2022, notified by the Drug Regulatory Authority of Pakistan (DRAP), it is the legal obligation of the pharma industry to nominate or appoint a pharmacovigilance officer for products registered under the DRAP Act, 2012. The pharmacovigilance officer is required to perform the following duties:

      • To collect, record, and report adverse events and other safety data related to the product to the National Pharmacovigilance Centre (NPC) within the specified time frame.
      • To conduct periodic safety update reports (PSURs) and risk-benefit assessments of the product and submit them to the NPC.
      • To implement risk management plans (RMPs) and risk minimization measures (RMMs) for the product as per the NPC’s recommendations.
      • To ensure compliance with the pharmacovigilance rules and guidelines issued by the NPC and DRAP.
      • To maintain pharmacovigilance records and documentation for at least 10 years.

      “The NPC was established by DRAP in July 2022 under the Pharmacovigilance Rules, 2022, with the aim to enhance the pharmacovigilance activities in the country . The NPC is responsible for collecting, analyzing, monitoring, and preventing adverse effects of therapeutic goods, as well as reviewing and assessing safety data, conducting risk evaluations, and communicating with health authorities, health professionals, and patients. The NPC also provides training, guidance, and support to the provincial or regional pharmacovigilance centres, public health programs, and product registration holders.”

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      Training on Pakistan Single Window for DRAP Module

      Asad Ullah Drugs, Events, Licensing and Inspections, Regulatory Updates , , ,

      Pakistan Single Window-PSW is working on the automation of trade-related business processes of the Drug Regulatory Authority of Pakistan (DRAP). The existing business processes of issuance of License, Permits, Certificates and Others (LPCOs) by DRAP has been mapped in consultation with DRAP._

      In this context, Pakistan Single Window-PSW would like to invite you for a hybrid Training Session for the Drug Regulatory Authority of Pakistan-DRAP Module. In this session our Domain and System Experts will provide you the walkthrough of filling Entity Registration, License Registration (DML), Product Registration and SECP Verification.

      The meeting is scheduled for Friday, 25th August 2023 from 03:30 PM till 04:30 PM. Manufacturers/DML holders working in Karachi are requested to join us physically at Main Conference Room, Fifth Floor, Bahria Complex-1, M.T Khan Road, Karachi.

      Interested members are requested to register themselves by clicking below:
      Registration Link: https://us06web.zoom.us/webinar/register/WN_42ArK1qtS1Sf9Xm2bcTi9g

      Relevant members of Pharma Industry and associations are encouraged to get themselves register for this session for better understanding of new module. Pease note, only registered members will be allowed to attend this training session.