Home > Uncategorized

Uncategorized

Recall Alert: Recall of 6 Batches of Neutrozole Infusion Manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore

Muhammad Ayub Naveed Recall Alerts, Uncategorized

Recall Alert

Download

DRAP Alert NoNo I/S/11-24-51
Action Date29th 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 The Provincial Inspector of Drugs, Punjab collected the samples of Neutrozole Infusion from various districts of Punjab and sent for test / analysis. The Drugs Testing Laboratory, Multan has declared various batches the said product, manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore, as a Substandard product. The details of the case are as under:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Neutrozole Infusion 100ml
 
Reg. No. 046878  		Metronidazole (500mg/100ml)Batch No. MZ023,
MZ028,
MZ010,
MZ007,
MZ006,
MZ003		M/s. Neutro Pharma (Pvt.) Ltd., 9.5 Km, Sheikhupura Road, Lahore-Pakistan.
Risk Statement:Administration of products containing bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc. which may have fatal consequences.
Action Initiated-The manufacturer has been directed to immediately recall the defective batch of product from the market. The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market
-The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. 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.

–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.

    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

    Download

    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.

      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

      Rapid Alert: Contaminated Lot of Sorbitol Identified in Karachi

      Asad Ullah Uncategorized
      Download

      Rapid Alert

      DRAP Alert NoNo  II/S/04-24-19
      Action Date15th May 2024
      Target Audience·         Regulatory Field Force.
      ·         Therapeutic Goods industry
      ·         Manufactures of Oral liquid preparations
      Problem StatementThe Federal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis report No. RM-2-24-000136 dated 22-03-2024 declared the sample of Sorbitol (Batch 09-LM-023) sent to CDL Karachi by M/s. Herbiotics Healthcare Rawalpindi in compliance to letter vide No. 03-41/2023-QC dated 01-12-2023.

      Details of CDL test/analysis report are as under:

      Product NameManufacturer as per labelBatch No.Test ResultsLimits
      Sorbitol  M/s. Master Sweetener, Karachi09-LM-023Ethylene Glycol: 0.6431% Does not complyEthylene Glycol: NMT 0.1%  
      Risk Statement:Ethylene Glycol (EG) contaminated raw materials when used in oral liquid preparations can lead to serious health risks. When ingested, EG is converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
      Action Initiated: –The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of Sorbitol. The Regulatory Field Force has also been instructed to seize all preparations manufactured using the same batch of Sorbitol if found in the market.
      Advice for Therapeutic Goods Manufacturers: –Manufacturers of therapeutic goods are required to follow these instructions:
       
      1.      Recall Products: If any batch was manufactured using the same lot of Sorbitol that has been identified as contaminated, all finished products from local and export markets should be recalled.
      2.      Hold Other Batches: All finished products manufactured from same lot of sorbitol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain.
      3.      Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.
      4.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.
      5.      Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.
      Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
      Advice for Healthcare Professionals: –DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of DEG/EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centers.
      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.  Further information on reporting problems to DRAP is available on this link.

      DRAP Releases 2nd Edition of Guidelines for Good Clinical Practice (GCP) Inspections

      Mughees Mudassir Uncategorized

      The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce the release of the second edition of the “GUIDELINES FOR CONDUCT AND REPORTING OF GOOD CLINICAL PRACTICE INSPECTIONS“.

      These guidelines provide a comprehensive framework for all stakeholders involved in clinical research related to therapeutic goods in Pakistan.

      Key Features of the Updated Guidelines:

      • Enhanced Clarity: This second edition streamlines the guidance, making it easier for sponsors, investigators, research institutions, and laboratories to understand the procedures for GCP inspections.
      • Broader Applicability: The guidelines now explicitly cover Contract Research Organizations (CROs), BA/BE Study Centers, and Bio-Analytical Laboratories involved in clinical trials.
      • Improved Transparency: The revised document clearly outlines the roles and responsibilities of both clinical research participants and DRAP inspectors during the inspection process.
      • Risk based GCP Inspections

      Benefits of Following these Guidelines:

      • Ensuring Patient Safety: Adherence to GCP principles is critical for safeguarding the well-being of participants in clinical trials.
      • Promoting Research Quality: Clear communication of inspection procedures fosters a transparent and high-quality research environment.
      • Facilitating Regulatory Compliance: Understanding inspection protocols allows research entities to prepare effectively and demonstrate compliance with DRAP regulations.

      We encourage all parties involved in conducting clinical research in Pakistan to download and familiarize themselves with these updated guidelines.

      Download the “GUIDELINES FOR CONDUCT AND REPORTING OF GOOD CLINICAL PRACTICE INSPECTIONS”

      Recall Alert: Drug Product; Cetafend Infusion (Batch # 23RC55) by M/s Friends Pharma (Pvt.) Ltd, Lahore

      Asad Ullah Uncategorized

      Recall Alert

      Download

      DRAP Alert NoNo I/S/12-23-47
      Action Date28th Dec, 2023
      Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
      · General Public
      Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. KQ-11-23-000155 dated 12-12-2023 has declared the Cetafend Infusion Batch No. 23RC55 as of substandard quality.

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch No Manufacturer
      Cetafend 1g/100mL Infusion
       
      Reg.No 091872      		ParacetamolBatch No. 23RC55
       
      Mfg. Date: 10-2023
      Exp. date: 10-2025      		M/s. Friends Pharma (Pvt.) Ltd.
      Ferozepur Road, Lahore
      Risk Statement:Cetafend Infusion contains Paracetamol, a medicine used to treat mild to moderate pain. Paracetamol can also be used to treat fever (high temperature). Administration of products containing visible solid particles to patients through IV infusion may lead to complications, as well as an increased risk of venous thromboembolism. The age-profile of patients is important and young patients especially seem to be at risk.
      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: Counterfeit and Unregistered Paracetol 500mg Tablets identified in the Market

        Asad Ullah Uncategorized
        Download

        Rapid Alert

        Falsified and Unregistered Paracetol 500mg Tablets

        DRAP Alert NoNoI/S/ 02-20-09
        Action Date6th April, 2023
        Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
        2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
        3. General Public
        Problem StatementDrug inspector Diamer/Astore took the sample of Paracetol 500mg Tablets (Bach No. 470) and sent it to Drug Water and Food Testing Laboratory, GB, for test/analysis, which has been declared as a counterfeit product.

        The product detail as mentioned on the label is as under: –

        Therapeutic Goods Affected:-

        SrProduct NameCompositionBatch #Manufactured by Remarks by Laboratory
        1Paracetol 500mg Tablets

        Mfg. Date: 11-2022
        Exp. date:  11-2024        		Paracetamol 470Ms. Roryan Pharmaceuticals (Pvt.) Ltd., Peshawar.The sample is Counterfeit under the Drugs Act 1976 as it resembles with Panadol 500mg Tablets by M/s GSK.
        The Product has also been declared Un-Registered By DRAP*.
        * Registration Board in its 312th meeting has cancelled the registration of Paracetol 500mg Tablets of M/s Roryan Pharmaceutical Industries Pvt. Limited Peshawar, bearing Registration No. 059421. Cancellation letter was issued on 09-12-2021 vide No. 3-5/2021-RRR (M-312).
        Risk Statement:Paracetamol is used for mild to moderate pain including headache, migraine, nerve pain, toothache, sore throat, period pains, and general aches and pains. It is also used to help reduce fever. Unregistered/falsified products may lead to adverse reactions including but not limited to the following:
        ·         Blood disorders, such as thrombocytopenia and leukopenia.
        ·         Liver and kidney damage.
        · Sub-therapeutic effect regarding fever, inflammation, and pain control.
        Action InitiatedThe manufacturer has been directed to immediately recall this product from the market. The Regulatory Field Force has been directed to increase surveillance throughout the supply chain. 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 supplier of such products 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 product(s).

        -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 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.