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Recall Alert: Drug Products; Recall of 02 Substandard Batches Manufactured by M/s Gulf Pharmaceuticals from the Market

Asad Ullah Product Recalls, Recall Alerts, Uncategorized

Recall Alert

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DRAP Alert NoNo I/S/11-24-47
Action Date08th November, 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
– General Public
Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. IP-9-24-000082 dated 15-10-2024 has declared the product namely Hi-Z syrup batch No. S1427 as of substandard quality. Details of CDL test report are as under:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Hi-Z syrup

(Reg. no. 075129)		20mg Elemental Zinc/5mlBatch No. S1427
 
Mfg Date: 07-2024
Exp Date: 06-20226		M/s. Gulf Pharmaceuticals, Islamabad
Ufen Oral Suspension

(Reg. No. 090274)		100mg Ibuprofen/5mlBatch No. S1451
 
Mfg Date: 08-2024
Exp Date: 07-20226		M/s. Gulf Pharmaceuticals, Islamabad
Risk Statement:Elemental Zinc syrups are used for reduction of duration and severity of diarrhea in children who are undernourished. Moreover, in patients suffering from Wilson disease, taking zinc by mouth improves symptoms by blocking how much copper is absorbed and increases how much copper the body releases. Sub-standard Zinc preparations may lead to complications in above mentioned conditions.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce fever, pain, and inflammation. Altered pH of an oral preparation may lead to gastrointestinal irritability, decreased stability and altered absorption of the product. These factors can ultimately lead to the therapy failure.
Action Initiated–The manufacturer has been directed to immediately recall the defective batches of products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of products. 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) also increased 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 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 these 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: Falsified Rhophylac 300mcg PFS, Human Anti-D Immunoglobulin Injection Identified in Market

    Asad Ullah Recall Alerts
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    Rapid Alert

    DRAP Alert NoNo I/S/11-24-42
    Action Date07th November, 2024
    Target Audience·         National Regulatory Field Force.
    ·         Distribution, Pharmacies and Medical Stores
    ·         Healthcare Professionals – Physician, Pharmacist, Nurses
    · Maternal and Child Health Centres
    Problem StatementM/s Hakimsons Impex (Private) Ltd, Karachi, has notified DRAP regarding the presence of falsified Rhophylac 300mcg PFS in the market across Pakistan and also referred to letter No. 438/PDI-ZR/PWR, received from Provincial Inspector, Peshawar for verification of the sample. The packaging of the product shows two different batch numbers while barcode scan displays another batch number.
    Product nameBatch/Lot No.Manufacturer Name
    (as per label)     		Mfg. dateExp. date
    Rhophylac 300mcg PFS,
    Human Anti-D Immunoglobulin    		P100547971
    P100644011
    ­­­­
    Barcode Batch:
    P100585096    		M/s CSL Behring AG,
    Wankdorfstrasse 10,
    CH-3000 Bern 22,Switzerland.     		10-202309-2026
    Threat to Public HealthThe Anti-D immunoglobulin is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Falsified Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the products are unknown
    Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities in market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered product
    Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link.

    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 ConsumerConsumers 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 these 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.

    Decisions of 72nd Meeting of Medical Device Board; Deficiency letters for Medical Devices Applications

    Asad Ullah Medical Devices Board, Uncategorized

    The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 72nd 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.

    72nd Meeting MDBDownload

    Implemmentation of Industry E-Reporting System for Reporting of Adverse Drug Reactions by Registrtaion Holders

    Asad Ullah Drugs, Pharmacovigilance

    The Drug Regulatory Authority of Pakistan (DRAP) has launch the Industry e-reporting System for Individual Case Safety Reports (ICSRs). This new system, developed in collaboration with the Uppsala Monitoring Centre (UMC), aims to simplify and streamline the submission process for registration holders, including manufacturers and importers of therapeutic goods. The National Pharmacovigilance Centre (NPC), established under the Division of Pharmacy Services, will oversee this initiative to ensure the safety of therapeutic goods, in line with the Pharmacovigilance Rules, 2022.

    Since its inception, DRAP has been committed to promoting transparency and facilitating document submission through various tools. The new Industry e-Reporting System will allow registration holders to submit ICSRs via two modules: E2B XML submission and manual data entry for non-E2B pharmaceutical companies. Access to this system will be secure, with two accounts provided per registration holder.

    Following a successful pilot project with a selected number of registration holders, DRAP is now extending the system’s scope to all registration holders. Starting from 8th November 2024, all future ICSRs must be submitted through this system. For further guidelines, please refer to the “Industry e-Reporting Manual for Registration Holders” available on the DRAP website.

    We appreciate your cooperation in ensuring the safety and efficacy of therapeutic goods in Pakistan.

    Implemenation letter of Industry e-reporting systemDownload

    Directive of Registartion Board; Submission of Summary of Product Characteristics (SmPC), Prescribing Information(PI) and Patinet Leaflet(PIL)

    Asad Ullah Drugs

    Registration Board in 340th meeting held from 1st October to 2nd October 2024, directed applicants to submit the Summary of Product Characteristics (SmPC) including Prescribing Information (PI) along with Patient Information Leaflet (PIL) against section 1.5.14 of CTD for the Finished Pharmaceuticals Product (FPP).

    It is hereby circulated for compliance and information of all stakeholders.

    CIRCULAR-SmPC-PILDownload

    Career Opportunities: Applications are invited for Various Positions in DRAP

    Ijaz Mustafa Careers, General

    The Drug Regulatory Authority of Pakistan (DRAP) employs over 500 people from a range of educational backgrounds, who have the skills and experience to perform regulatory operational services under the DRAP Act 2012. These include professionals both technical (qualifications in medicine and pharmacy-related sciences, etc.) and non-technical (qualifications in law, information and communication technology, accounts, human resources management, etc.)

    DRAP is mandated to provide effective coordination and enforcement of The Drugs Act, 1976, and harmonization of inter-provincial trade and commerce of therapeutic goods. Being the national regulatory body for therapeutic goods, DRAP performs various regulatory functions of therapeutic goods including licensing of establishments, product registrations/marketing authorizations, pharmacovigilance, post-market surveillance and market control, regulatory inspections, laboratory testing, clinical trials oversight and lot release of biologicals.

    Details of Vacant Positions advertised are as below.

    46×4-and-48×4-Ad-25-10-24Download