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Rapid Alert: CRACKDOWN AGAINST FALSIFIED/SPURIOUS DRUGS

Muhammad Ayub Naveed Uncategorized
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Rapid Alert

DRAP Alert NoNo  I/S/02-25-18
Action Date17th February, 2025
Target Audience1·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
2·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
3. General Public
Problem StatementDrug Testing Laboratory, Sindh has informed to Drug Regulatory Authority of Pakistan that samples of following products taken by various provincial drug inspectors, have been declared ‘Spurious’ (falsified). Moreover, the following firms and their associated products were found to be fictitious. The details of the reports are as below:

The product identification details are as under:

Therapeutic goods affected:

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)		Remarks
Evosef 250mg capsule
(Cephradine 250mg)		HF-001Purported to be manufactured by East Pharmaceutical 19-Km Sheikhupura road, LahoreSpurious. Cephradine not identified
Mirzpan Suspension 100mg/5ml
(Cefixime)		0008M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur.Spurious, Cefixime not identified
Mirzolam Tablet 0.5mg (Alprazolam)0007M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur.Spurious, Alprazolam not identified
Bromalax Tablet 3mg (Bromazepam)B-01M/s Brom Pharmaceuticals (Pharmaceutical Industries), 21-Km Ferozpur Road, Lahore.Spurious, Bromazepam not identified
Malixime Suspension 200mg/5ml
(Cefixime)		78011M/s Menakline Pharma, S Site Plot 11, Korangi Industrial Area, Karachi.Spurious, Cefixime not identified
Lexopam Tablet 3mg (Bromazepam)B-01M/s Porm Pharmaceuticals (Pharmaceutical Industries), 220 Industrial Estate Hayatabad, Peshawar.Spurious, Bromazepam not identified
Zionex Tablet 0.5mg (Alprazolam)0032M/s Multicare Pharmaceutical, Plot # 23, Korangi Industrial Area, Karachi.Spurious, Alprazolam not identified
Tramaking-225 Mega tablet 225mg
(Tramadol HCl)		TRD2002Name of Manufacturer not mentioned.Spurious
Alcoxime Suspension 100mg/5ml
(Cefixime)		A2011M/s Alpine Laboratories (Pvt.) Ltd: Plot# A-41, S.I.T.E Indsutrial Area, Sector 3 North Karachi Super Highway 75500-Pakistan.Spurious, Cefixime not identified

Risk Statement:Falsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences.
Action InitiatedThe Regulatory field force has been directed to conduct surveillance activities throughout the supply chain to confiscate the counterfeit product. 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 product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation.
Advice for Healthcare ProfessionalsAll pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products.

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 at this link.
Advice for ConsumerConsumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product and report the same to DRAP through Adverse Event Reporting Form or online through this link.

Recall Alert: Substandard Product “Heparin-Indar Solution for Injection 5ml” Batch No. 64B0223B Mfg. By PRJSC <INDAR> Ukraine.

Muhammad Ayub Naveed Uncategorized

Recall Alert

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DRAP Alert NoNo I/S/01-25-11
Action Date16th January 2025.
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 Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples of below product have been reported as substandard by Drug Testing Laboratory (DTL) Lahore:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Heparin-Indar solution for injection 5ml

(Heparin Sodium 2000IU/ml)Batch No.
64B0223B		PRJSC <Indar>, Ukraine, 02099, Kyiv, 5 Zeoshyvalna Str.
Risk Statement:The use of substandard injections may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions.
Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments has 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: Substandard Product “Sterile Water for Injection 5ml” Batch No. 224 Mfg. By M/s Pharmedic Laboratories (Pvt.) Ltd., Lahore

    Muhammad Ayub Naveed Uncategorized

    Recall Alert

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    DRAP Alert NoNo I/S/01-25-06
    Action Date05th January 2025.
    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 Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples below product has been reported substandard by Drug Testing Laboratory (DTL) Lahore:

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Sterile Water for Injection, 5mlSterile Water for Injection,Batch no. 224
    		Pharmedic Laboratories, Lahore
    Risk Statement:
    The use of substandard injections may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions    .
    Action Initiated-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: Recall of Substandard Folic Acid Tablet Batches (490, 612) Manufactured By M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi.Recall Alert:

      Muhammad Ayub Naveed Uncategorized

      Recall Alert

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      DRAP Alert NoNo I/S/12-24-56
      Action Date18th December, 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 of various districts of Balochistan collected the samples of Folic acid Tablet and sent for test / analysis. The Drug Testing Laboratory, Quetta has declared following batches of Folic acid Tablet, manufactured by M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi, as of substandard quality based on uniformity of weight:

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
      Tablet Folic Acid
      Reg. No. 000859      		Folic acid 5 mgBatch No. 490
      Batch No. 612      		M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd. 4/1, A&B, Block-21, Federal “B” Industrial Area, Karachi-75950 
      Risk Statement:Folic Acid Tablets not complying with the uniformity of weight specification could result in inconsistent dosages of the active pharmaceutical ingredient (API), potentially leading to reduced therapeutic efficacy or an increased risk of adverse effects in patients.
      Action Initiated-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: Substandard Dexyken 300 mg Tablet Batch No. Kf23006  Manufactured By M/s. Kanel Pharma, Plot 6, Street SS-3, Rawat Industrial Estate, Islamabad

        Muhammad Ayub Naveed Recall Alerts, Uncategorized

        Recall Alert

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        DRAP Alert NoNo I/S/12-24-55
        Action Date12th December, 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. KQ-9-24-000142 has declared the subject mentioned batch of product Dexyken 300mg tablet as of substandard quality. Details of CDL test report are as under:

        Therapeutic Good(s) Affected: –

        Product NamesCompositionBatch DetailsManufactured by
        Dexyken Tablet

        Reg# 075234        		Dexibuprofen 300 mgBatch no. KF23006
        Mfg date: 06/2023
        Expiry date:
        06/2025        		M/s. Kanel Pharma, Islamabad
        Risk Statement:Dexibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk.
        Action Initiated-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: Recall of 6 Batches of Neutrozole Infusion Manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore

          Muhammad Ayub Naveed Recall Alerts, Uncategorized

          Recall Alert

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          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

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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.

              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