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Recall Alert: Drug Product; Albex 200mg Tablets (Batch#112) by M/s Swat Pharmaceuticals, Swat

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Recall Alert

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DRAP Alert NoNo II/S/09-23-34
Action Date22th 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

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Albex 200mg Table
 
Reg No. 020291

Albendazole 200mgBatch No 112
 
Mfg date 04.2023
Exp date 03.2025		Ms. Swat Pharmaceutical,
Swat.
Risk Statement:Albendazole is an anthelminthic drug used to treat various parasitic worm infections. Substandard preparations of albendazole tablets may lead to treatment failure or suboptimal therapeutic effects, adverse effects, and increased antimicrobial resistance by exposing the parasitic worms to suboptimal concentrations of the drug.
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) 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.

    Rapid Alert; Drug Product: Unregistered and Falsified Lipiodol Ultra Fluide 480mg/mL Injection

    Asad Ullah Recall Alerts
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    Rapid Alert

    DRAP Alert NoNo  I/S/09-24-37
    Action DateOctober 05, 2023
    Target Audience1. Regulatory Field Force.
    2. Healthcare Professionals – Physicians, Pharmacists, and Nurses.
    3 Procurement officer at hospitals and institutions
    4. General Public.
    Problem StatementThe regulatory field force of DRAP and the Chief Drug Inspector Office, Karachi have identified a suspected falsified lot of Lipiodol Ultra Fluide 480mg/ml Injection which was intended to supply to tertiary care hospitals. The said product is not registered in Pakistan and is not imported using special permission pathways.
    Threats to Public HealthThe use of falsified or counterfeit Lipiodol injection can pose serious health risks as it may contain unknown ingredients or no active ingredient at all. This can lead to ineffective treatment, worsening of the condition, or unexpected side effects. In some cases, falsified products have been found to contain toxic materials which expose patients to harmful substances. The safety, sterility, and quality of the falsified products referenced in this alert are also unknown.

    The product identification details are as under: –

    Therapeutic Goods Affected:-

    Product NameCompositionBatch / LotManufacture Name (as stated on label)Remarks
    Lipiodol Ultra Fluide 480mg/ml Solution for Injection (10ml)

    Registration No. Nil    		Ethiodized-oil
    (radio-opaque contrast injection)    		Batch No.: 15LU606A

    Exp. Date:
    07-2024    		Guerbet, 15 rue des Vanesses, Zone Paris Nord II FranceThe outer packaging, solution colour and consistency were different from the comparison to the original product.
    Comparison of falsified Product against the original product by G.
    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 at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product.

    -Adverse reactions or quality problems experienced with the use of these products 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 should 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.

    National Control Laboratories for Biologicals, DRAP issued Guidelines for Lot Release of Biological Products

    Asad Ullah Drugs

    The regulation of lot release is an integral regulatory control to ensure the quality and safety of biological products. Its purpose is to verify that each batch/lot of the product meets the stipulated standards of manufacturing and quality control. The National Control Laboratory for Biologicals (NCLB), Islamabad assumes the responsibility of overseeing lot release function through reviewing the manufacturer’s protocol, analytical methods and summary protocol, and also conduct analytical testing if necessary. This is aimed at assuring that every product batch/lot that enters the market adheres to the approved specifications at the time of registration, including any post-registration modifications or variations. The primary objective is to safeguard the public from substandard product batches/lot.

    The National Control Laboratories for Biologicals, DRAP has published guideline on the procedural requirement for lot release of biological products. This guidance document was drafted and uploaded in May 2023 seeking comments from stakeholders. It provides an overview of the lot release process how the procedure is established and what products are covered under the lot release system.

    Guideline for lot release of biological drugsDownload

    Shanghai Cooperation Organization (SCO) Pharmaceutical Development Conference; CEO DRAP emphasis cooperation to ensure drug safety and advancing research in the pharmaceutical field

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    Shanghai Cooperation Organization (SCO) Pharmaceutical Development Conference; CEO DRAP emphasis cooperation to ensure drug safety and advancing research in the pharmaceutical field

    2nd SCO Conference on Pharmaceutical Cooperation

    September 25, 2023, Suzhou

    The SCO conference on the development of medical and pharmaceutical cooperation was held in Suzhou, China on September 25, 2023. The conference was attended by representatives from the public and private healthcare sectors of the Islamic Republic of Iran, the Republic of Kazakhstan, the People’s Republic of China, the Kyrgyz Republic, the Islamic Republic of Pakistan, the Russian Federation, and the Republic of Uzbekistan.

    Mr. Asim Rauf, appreciated the organization of this significant event, which plays a crucial role in promoting regional cooperation and development in the pharmaceutical sector. He added that the SCO region holds immense potential for enhancing pharmaceutical collaboration, and we are committed to contributing to this shared vision. The platform of SCO offers an excellent opportunity to share insights, learn from each other’s experiences, and work collectively towards a safer, more accessible, and sustainable pharmaceutical landscape.

    The pharmaceutical industry in Pakistan is evolving from its modest beginnings to become a significant contributor to our national economy as well as meeting around 80 % of domestic needs. Pakistan is eager to collaborate with our fellow SCO member states to harness the full potential of the pharmaceutical sector.

    DRAP finalized the 2nd Edition of Guidelines on Post-Registration Variation of Drug Products

    Asad Ullah Drugs

    DRAP has finalized the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. Registration / Marketing Authorization holders are responsible for the safety, efficacy, and quality of drug products that are placed on the market throughout their approved life cycle.

    This guidelines are intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.

    These Guidelines will assist both Regulators and Industry on the regulation of variation / changes to the original registrations / Market Authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required. Data requirements are listed out to evaluate the impact of the proposed / intended change on the quality, safety and efficacy of the locally manufactured / imported finished pharmaceutical and biological drug products intended for human and veterinary use.

    These guidelines are intended to provide supportive information for submission of post registration variation application by the registrations / marketing authorization holders of the finished drug products to implement a change. The draft guidelines were uploaded on the website in July 2023 seeking comments of stakeholders on the contents of document.

    The Guidelines have been finalized keeping in view the comments and suggestions of the Stakeholders. Please navigate to the Publications on the DRAP website for latest guidelines by DRAP.

    Post Registration Variation Guidelines (Edition 02)Download

    Decisions of 60th 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 its 60th 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/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.

    Deferred-letters-MDB-60Download

    116th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

    Ijaz Mustafa Enlistment Evaluation Committee, General

    The 116th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 23rd May, 2023. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

    Deferred_list_116_Meeting_rDownload