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Author: Muhammad Ayub Naveed

Decisions of the Medical Device Board from 75-85th Meetings

Muhammad Ayub Naveed Medical Devices Board

The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan, in its 75-85th meetings, has decided on the following applications for registration/enlistment of medical devices. The applicants, where applicable, are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The details are provided in the below attachments.

Decisions of the 75th Meeting of the Medical Device Board

Decisions of the 76th Meeting of the Medical Device Board

Decisions of the 77th Meeting of the Medical Device Board

Decisions of the 79th Meeting of the Medical Device Board

Decisions of the 80th Meeting of the Medical Device Board

Decisions of the 81st Meeting of the Medical Device Board

Decisions of the 82nd Meeting of the Medical Device Board

Decisions of the 83rd Meeting of the Medical Device Board

Decisions of the 84th Meeting of the Medical Device Board

Rapid Alert: CONTAMINATED PROPYLENE GLYCOL (BATCH # YFO1210911) PURPOTEDLY MANUFACTURED BY M/S. DONGYING HI-TECH SPRING CHEMICAL INDUSTRY CO LTD, CHINA.

Muhammad Ayub Naveed Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/03-25-32
Action Date15th March, 2025
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementDirectorate Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan vide test/analysis report No. 141002343, wherein the sample of Propylene Glycol (Raw Material) has been declared ‘Substandard’. The falsified excipient was detected in the unregulated supply chain marketed through Facebook page and tested by Drug Testing Laboratory (DTL), Lahore. The contaminated propylene glycol batch (YFO1210911) was purported to be manufactured by Dongying Hi-Tech Spring Chemical Industry China. The results of test have revealed that the level of EG in the batch was 91.4%, far exceeding the accepted criteria of 0.1%. Details of test/analysis report are tabulated as under:

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)		Remarks
Propylene Glycol
(Raw material)		YFO121091101-202401-2026M/s. Dongying Hi-Tech Spring Chemical Industry Co Ltd, ChinaThe sample is declared substandard
due to conatmination of Ethylene Glycol.
(Note: Earlier in December 2024, DRAP issued a Rapid Alert for the same batch of falsified Propylene Glycol (Raw material) tested by CDL Karachi in compliance to advisory issued by DRAP vide No. 03-41/2023-QC dated 01-12-2023. In this regard, Hi Tech Spring China has confirmed that the said batch is not their product. The firm has provided the original product label, and a comparison between the original and falsified product labels is presented below)

Risk StatementDi-Ethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations can lead to serious health risks. When ingested, EG and DEG are 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 InitiatedThe Regulatory Field Force has directed to take increase surveillance for identification of above mentioned contaminated batch of Propylene Glycol in the market and is investigating the entire supply chain of this batch. The Regulatory Field Force has also been instructed to seize all oral preparations manufactured using the same batch of propylene glycol if found in the market.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1.      Recall Products: If any batch was manufactured using the same lot of Propylene Glycol 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 the same lot of propylene glycol 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 ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

-Adverse Drug Reactions (ADR) 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 stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and 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.

Rapid Alert: CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUGS

Muhammad Ayub Naveed Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/03-25-31
Action Date13th March, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’. The details of the report are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)		Remarks
PENIVET-5 Injection
Each vial contains:
Benzyl Penicillin……500,000IU
Procaine Penicillin….1500,000IU
Streptomycin Sulphate…5g 
 
(For Veterinary use only)
 
Reg. No. 034290		VK-1496Purported to be manufactured by
M/s. Star Laboratories (Pvt) Ltd. 
(Animal Health Care Division) 23-Km, Multan Road, Lahore-Pakistan		Spurious with regardsto Section 3(zb)(i) & (ii) of Drugs Act 1976 and  ‘Substandard’ on the basis of Sterility test.

Risk StatementFalsified 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 to confiscate the abovementioned Un-Registered/falsified products. 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 suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 ConsumersConsumers 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 the above mentioned 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.

Rapid Alert: CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUGS

Muhammad Ayub Naveed Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/03-25-30
Action Date13th March, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared ‘Spurious’. The detail of report is as under

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch No*Mfg DateExp. DateManufacturer Name
(as per label)		Remarks
KLOZEN Eye Drops 5ml
(Tobramycin….0.3% & Dexamethasone….0.1%)		138M/s Zinta Pharmaceutical Industry,
168 – Industrial Estate Hyatabad, Peshawar.		‘Spurious’ with regards to Section 3(zb)(i) and ‘Adulterated’ with regards to Section 3(a)(iv) of Drugs Act, 1976.

Risk StatementFalsified 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 to confiscate the abovementioned Un-Registered/falsified products. 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 suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 ConsumersConsumers 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 the above mentioned 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.

Recall Alert: SUBSTANDARD PRODUCTS DECLARED BY PROVINCIAL DRUG TESTING LABORATORIES.

Muhammad Ayub Naveed Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/03-25-28
Action Date12th March, 2025.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

Therapeutic Goods (s) Affected: –

Product NamesCompositionBatch DetailsManufactured by

 
Syrup Divanza 120ml

 
Reg. No. 096103

Each 5ml contains:
Sodium Valproate eq. to Valproic acid …..250mg		021M/s. Hiranis Pharmaceuticals (Pvt.) Ltd.
E-145-149, North Western Industrial Zone, Port Qasim, Karachi.
Tablet Mebrosil Antacid

 
Reg. No. 007733
Each tablet contains:
Magnesium Trisilicate…500mg,
Aluminium Hydroxide…250mg		8576M/s. Jawa Pharmaceuticals (Pvt) Ltd,
112/10 Quaid-e-Azam Industrial Area, Kot-Lakhpat, Lahore.
Capsule Lanroz 30mg

 
Reg. No. 047803
Each capsule contains:
Lansoprazole….30mg		C-032M/s. Hisun Pharmaceuticals Indsutries,
37-A, R-2, Industrial Estate, Gadoon-Pakistan.
Sterile Disposable Fresline

 
Reg. No. MDIR-0001626		(Tubing Sets for Hemodialysis)2401151264Manufactured by: M/s Vital Healthcare SDN. BHD.,
Lot 3, Jalan sultan Mohamed 3, Bandar Sultan Sulaiman, 42000 Pelabuhan klang, Selangor Darul Ehsan, Malaysia.
 
Imported by: Fresenius Medical Care Pakistan (Pvt.) Ltd.,
TAMC, First Floor, 27-C III, M.M Alam Road, Gulberg III, Lahore.
Tablet AMLOShine 5mg

 
Reg. No.  062420		Each tablet contains:
Amlodipine as besylate…5mg		6752M/s Sunshine Pharmaceuticals,
Khan payara, near Saim Nala, Emanabad Road, Emanabad, Gujranwala
AME-CLOP Injection

 
Reg. No. 048388		Each 2ml contains:
Metoclopramide HCL….10mg		MC-120M/s Ameer Pharma (Pvt) Ltd.,
23-Km, Sheikhupura Road, Lahore.
Injection Anacobin 500µg

 
Reg. No. 047494
(Mecobalamin 500 µg/ml, 1ml)AF133M/s Epharm Laboratories,
A-40, Road No. 1, S.I.T.E., Super Highway, Industrial Area, North Karachi.
Tablet Normax 5mg

 
Reg. No. 062644		Each tablet contains:
Amlodipine as besylate…..5mg		327M/s Murfy Pharmaceuticals (Pvt) Ltd.,
8-Km Raiwind Road, Lahore.
Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
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.

    Rapid Alert: CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUGS

    Muhammad Ayub Naveed Recall Alerts
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    Rapid Alert

    DRAP Alert NoNo  I/S/03-25-28
    Action Date5th March, 2025
    Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
    2. Healthcare Professionals
    3. Pharmacies and medical stores
    Problem StatementDirectorate of Drug Control Punjab (DDCP) has informed the Drug Regulatory Authority of Pakistan that the samples of the below mentioned products have been declared ‘Spurious’.

    The product identification details are as under: –

    Therapeutic Good Affected:-

    ProductBatch No*Mfg DateExp. DateManufacturer Name
    (as per label)    		Remarks
    Syrup Carenol 60mL
    Each 5ml contains:
    Ammonium chloride 125mg,
    Sodium Citrate 55mg, Chlorpheniramine maleate 2.5mg
     
    Reg. No. 026907    		CL-036Purported to be manufactured by
    Well Care Pharmaceuticals, A/7, P.S.I.E. Sargodha-Pakistan.    		‘Spurious’ as per Drugs Act 1976, section 3(z-b) (i) and ‘Misbranded’  as per  section 39(s)(vi).
    Powder for Inj. 2Sum 2g
    Sterile powder of Cefoperazone sodium  eq. to Cefoperazone 1g, Sterile powder for sulbactam sodium eq. to Sulbactum  1g per vial
     
    Reg. No. 071447    		APK072Purported to be manufactured by
    Healthtek (Pvt) Ltd, Plot No. 14, Sector 19, Korangi Industrial Area Karachi -Pakistan.    		Spurious’ as per Drugs Act 1976, section 3(z-b) (i) & (ii) and ‘Adulterated’  as per  section 3(s)(iv) and ‘Substandard’ on the basis of Sterility.

    Risk StatementFalsified 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 to confiscate the abovementioned Un-Registered/falsified products. 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 suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
    Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 ConsumersConsumers 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 the above mentioned 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.

    Recall Alert: SUBSTANDARD PRODUCTS DECLARED BY PROVINCIAL DRUG TESTING LABORATORIES.

    Muhammad Ayub Naveed Product Recalls, Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/03-25-26
    Action Date4th March, 2025.
    Target Audience– National Regulatory Field Force.
    – Pharmacists and Chemists     in Distribution, Pharmacies and Medical Stores
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue Directorate of Drugs Control (DDC) Punjab and Senior Drug Inspector ICT Islamabad has informed DRAP that samples below product has been reported substandard due to presence of impurities by Drug Testing Laboratory (DTL) Lahore and Rawalpindi:

    Therapeutic Goods (s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by

     
    Ame-Pin injection 2ml

    		Tramadol HCl 100mgTD-038Ameer Pharma (Pvt.) Ltd., 23 KM, Sheikhupura road, Lahore
    Aqua-P Injection
    		Sterile Water For InjectionP-665Ipram International, Plot No. 26, SS-3, NIZ, Rawat Islamabad
    Flagyl Infusion
    		Metronidazole 500mgAD460Sanofi-Aventis Pakistan Ltd., Plot No. 23, Sector 22, KIA, Karachi
    Metroin Infusion
    		Metronidazole 500mgMT24-103Saturn Pharmaceuticals, 23Km,Thokar-Raiwind Rd, Lahore
    Euro-Flow CannulaIV Cannula24/87Euromed for Medical Industries SAE Cairo Egypt
    Rudazole Injection
    		Metronidazole 500mgRD-044Rukha Pharmaceutical & Laboratories, 537-D&E Sundar Industrial Estate Lahore
    Safemed Injection
    		Metronidazole 500mgS-699Ahad Intl., Pharmaceutical, 13KM Gomal Uni, Multan Road, DI Khan
    Pulmowell 120ml syrup
    		(Ammonium Chloride 30mg, Liquorice Ext. 50mg, Aniseed Oil 2.6ml)PLW-001Vital Phyto Parma (Pvt.) Ltd., 7 KM from GT Road, Sohawa Chakwal Road, Rawalpindi
    Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
    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 Products Declared By Provincial Drug Testing Laboratories:

      Muhammad Ayub Naveed Recall Alerts

      Recall Alert

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      DRAP Alert NoNo I/S/03-25-27
      Action Date4th March, 2025.
      Target Audience– National Regulatory Field Force.
      – Pharmacists and Chemists       in Distribution, Pharmacies and Medical Stores
      – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
      – General Public
      Problem / Issue Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
       Aqua-P InjectionSterile Water For InjectionP-665Ipram International, Plot No. 26, SS-3, NIZ, Rawat Islamabad
      Injection Neocobal 1 ml

      Reg. No. 071447      		Mecobalamin 0.5mg/mlS-2216M/s. Pulse Pharmaceuticals (Pvt.) Ltd.
      Sua Aasil, Raiwind Road, Lahore – Pakistan
      Syrup Antimin 60ml
      Reg. No. 025951      		Each 5ml contains:
      Loratadine …..5mg      		063M/s. Shaigan Pharmaceuticals (Pvt) Ltd,
      14-Km, Adyala Road, Rawalpindi – Pakistan
      Injection Cara-Lac

      Reg. No. 054997      		Ketorolac Tromethamine 30mg/mL24J013M/s. Caraway Pharmaceuticals,
      Plot 12, St. N-3, National Industrial Zone (RCCI), Rawat, Islamabad.
      Risk Statement:The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population.
      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.

        Rapid Alert: Presence of Unregistered Tramadol Formulations in the Market

        Muhammad Ayub Naveed Recall Alerts
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        Rapid Alert

        DRAP Alert NoNo  I/S/02-25-25
        Action Date27th February, 2025
        Target Audience1. Regulatory Field Force.
        2. Therapeutic Goods Industry
        3. Manufactures of Oral liquid preparations
        4. Healthcare professionals
        Problem StatementThe Federal Government Analyst, CDL, Karachi has notified the Drug Regulatory Authority of Pakistan that samples of the following products, seized by Customs, have been declared ‘Unregistered’ (falsified). The labels of these samples claim ‘Tramadol hydrochloride’ which has been confirmed by the test reports. Moreover, the labels do not provide any information regarding the manufacturer. The details of the reports are as below:

        The product identification details are as under: –

        Therapeutic Good Affected:-

        ProductBatch No*Mfg DateExp. DateManufacturer Name
        (as per label)        		Remarks
        Tramaking 225 TabletsTM-04403-202303-2026–Un-Registered (Falsified)
        New Tramadol 225 TabletsTRD201502-202202-2027–Un-Registered (Falsified)
        TramaKing 250 CapsuleTKC200103-202203-2027–Un-Registered (Falsified)
        New Royal 225mg TabletsTM-03704-202304-2026–Un-Registered (Falsified)
        Tamral-250 Tablets243NIL03-2026–Un-Registered (Falsified)
        Tramaking Mega 225 TabletsTRD200205-202205-2027–Un-Registered (Falsified)
        TramaKing 250 TabletsTRK200103-202203-2027–Un-Registered (Falsified)

        Risk StatementFalsified products having no 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 to confiscate the abovementioned Un-Registered/falsified products. 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 suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
        Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 ConsumersConsumers 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 the above mentioned 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.

        Minutes of the 344th Meeting of the Registration Board Held on 31st December, 2024 to 02nd January, 2025

        Muhammad Ayub Naveed Registration Board

        The Drug Registration Board convened its 344th meeting on December 31st, 2024 to February, 20252 in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.

        Minutes-of-344th-Meeting-of-Registration-BoardDownload