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Month: July 2023

Recall Alert: Medical Devices; Disposable Infusion Set by M/s Rehman Rainbow (Pvt), Lahore

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/07-23-28
Action Date27th July, 2023
Target Audience· Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses.
· Procurement Officers at Hospitals and Healthcare Institutions.
· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue Central Drugs Laboratory, Karachi received samples of Surgee Disposable Infusion Set manufactured by the M/s Rehman Rainbow (Pvt) Ltd , Industrial Estate, Kot Lakhpat, Lahore for testing. CDL has declared the sample as substandard based on the analysis for not complying the sterility criteria. Accordingly, the manufacturing company had been directed to recall all the defective product from the market.

Therapeutic Goods Affected:-

Product NamesProduct DescriptionBatch NoManufacturer
Surgee Disposable Infusion Set

Mfg Lic No 000510
Reg No 071602		Intravenous Infusion setBatch No IV0523
 
Mfg date 05.2023
 
Exp 04.2028		M/s Rehman Rainbow (Pvt) Ltd Lahore
 
Risk Statement:Use of Non sterile IV set poses a serious risk of patient harm and due to non-sterility can lead to bacteremia and sepsis.
Action Initiated-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.

-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.

-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 these defective lots of the Medical Device.  

-Adverse reactions or quality problems experienced with this product may 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 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 Medical Device.

-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: Medical Devices; Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by Medtronic, USA

    Asad Ullah Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/07-23-29
    Action Date27th July, 2023
    Target Audience• Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses.
    • People implanted with affected ICDs and CRT-Ds.
    • Procurement Officers at Hospitals and Healthcare Institutions.
    • Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
    Problem / Issue Medtronic, USA received reports for their implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) for risk of patient harm as a result of low or no energy output when high voltage therapy is needed due to inappropriate activation of the Short Circuit Protection (SCP) feature. The issue is more likely to occur for devices with a glassed feedthrough that are configured to deliver therapy in the AX>B delivered pathway. Accordingly, the manufacturing company is recalling all the defective product from the international market including Pakistan.

    Therapeutic Goods Affected:-

    Brand NamesProduct DescriptionLot No and CodesManufacturer and Distributor
    o Cobalt XT, Cobalt, Crome ICDs and CRT-Ds

    o Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds

    o Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs    		Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)  are intended to monitor and regulate heart rate and rhythmMedical Device Recall Database Entries (FDA)
    (click to open)

    Distribution Dates: October 13, 2017 to June 9, 2023

    		Medtronic USA

    Distributor in Pakistan:
    M/s Medtronic Pakistan (Pvt) Ltd. Karachi.
     
    Risk Statement:Defective ICDs, CRT-Ds poses a risk of patient harm as a result of low or no energy output when high voltage therapy is needed. Therefore, reduced-energy shock, or no shock at all, may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury, or death.
    Action Initiated-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.

    -All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. The remaining stock should be quarantined and returned to the supplier/company.

    -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 these defective lots of the Medical Device. Patient using the affected device should immediately contact their doctors for further guidance. Furthermore, Medtronic issued an Urgent Medical Device Correction notice to customers.

    The communication provided the following required actions for software issue related to this recall: 

    • Do not prophylactically replace devices for this issue.
    • Program all high voltage therapy pathways B>AX in all therapy zones to minimize the risk of this issue.
    • Prioritize reprogramming patients with a history of high voltage therapy and Rx1 programmed AX>B.
    • Encourage patients with AX>B programming in any high voltage therapy sequence to attend their next scheduled follow-up in-clinic for device reprogramming.
    • Remotely monitor patients following normal clinical protocol.

    Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue:

    1. Reduced- or no-energy high voltage therapy is displayed in Episode Text (regardless of programmed pathway)
    2. A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy.

    -Adverse reactions or quality problems experienced with this product may 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 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 Medical Device.

    -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: Falsified Sojourn ( Sevoflurane) Liquid For Inhalation

      Asad Ullah Recall Alerts
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      Rapid Alert

      Falsified Sojourn ( Sevoflurane) Liquid For Inhalation

      DRAP Alert NoNo  II/S/07-23-27
      Action Date24th July 2023
      Target Audience1. Regulatory Field Force
      2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
      3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
      4. General Public
      Problem StatementThe federal Inspector of Drugs, Quetta, took sample of suspected Sojourn liquid for inhalation from two different batches and sent it for analysis to the laboratory. The Central Drug Testing Laboratory, Karachi declared these samples as “Spurious” based on the analysis. The laboratory also identified the differences in the labeling and packaging of the falsified products in comparison to the authorized pack of registered products.

      The product detail as under: –

      Therapeutic Goods Affected:-

      SrProduct NameBatch #Mfg. DateExp. DateManufactured by
      (as stated on label)      		Remarks
      1Sojourn Liquid for Inhalation
       
      Reg.No. 088891
      		S0502C11
      S0512C14      		Mar-22
      		Mar-27M/s Priamal Critical Care, Inc. USAThe sample is declared spurious for a non-complying identification test for Sevoflurane.  Instead, lab identified chloroform in the samples.
      *The differences noted in the labeling and packaging of sample products declared as spurious in comparison to the authorized product from the marketing authorization holder are summarized in a table as Annexure-I.
      Risk Statement:Sojourn (Sevoflurane) Liquid is an inhalational anesthetic agent which is indicated for use in the induction and maintenance of general anesthesia. It may lead to life-threatening reactions as the safety, quality, and efficacy of the product are unknown.
      Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the 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 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 products.

      -Adverse reactions or quality problems experienced with the use of this product 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.

      Consultative Workshop on Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods

      Asad Ullah Events , , , , ,
      Consultative Workshop on Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods

      National Regulatory Authorities are responsible to ensure that recalls are handled properly and promptly, including alerting the public, classifying the type of drug recall, and safely removing the affected product from the market. DRAP in collaboration with WHO, organized one-day consultative workshop on “Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods” held at DRAP Headquarter in Islamabad on 20th July, 2023. The workshop was aimed at ensuring strong communication skills and knowledge to effectively handle the SF threat and execution of recalls and rapid alerts. Government Analysts from all Quality Control Laboratories (QCLs) working under the DRAP Act 2012 and Drug Act 1976, as well and representatives from drug control administration of all federating units participated in the workshop.

      The workshop focused on the following key objectives:

      1. Implementation of effective and integrated Recall and Rapid Alert system in Pakistan.
      2. Emphasizing the need and importance of Recall and Rapid Alert System.
      3. Training and building capacity of all the participants.
      4. Enhancing coordination and communication with provincial governments and related departments.
      5. Safe disposal system of SF products
      6. Improvement in DRAP’s guidelines and harmonization with International best practices.

      Risk Communication flow chart for handling SF threats

      Core Activities and Topics Covered

      1. Introduction and Objectives of Workshop The day began with an overview of current system for rapid alerts and recalls for removing defective therapeutic goods from the market. Director Quality Assurance and Lab Testing, DRAP briefed the participants on the strategies designed to strengthen the collaboration among regulators and QCLs of all federating units. He emphasized the importance of timely and accurate communication to combat the challenge of SF therapeutic goods.

      2. Overview of DRAP’s guidelines on Recalls and Rapid Alerts of Defective products This session explained the guidelines of DRAP and action response currently opted by DRAP, highlighting its strengths and limitations. Participants engaged in group discussions to evaluate which methods would be most effective in different scenarios.

      3. WHO recommendation on Recalls and Rapid Alerts System in the benchmarking visit Participants were introduced to the WHO GBT indicators, sub-indicators and IDPs, WHO recent visit and their recommendation for the improvement of the current Rapid Alert system. The trainer comprehensively delivered the details, ensuring that the information provided is easily comprehensible and actionable.

      4. Harmonization of Terminologies for Defective Products and Role of QCLs in Detection and Disposal of SF products This segment focused on the terminologies being used nationally and their harmonization with WHO recommended terminologies. Later the role of Quality Control Laboratories was emphasized and discussed in group discussion. 

      5. Best practices for storage and disposal of SF products This session highlighted the current available practices and international practices as recommended by the WHO for safe storage and disposing of the SF products.

      6.Effective communication among stakeholders for their removal from the market ;Recall is an effective means of protecting the public from a defective or potentially harmful product, and strong communication among relevant stakeholders is essential for the effective recall of SF Products. It was suggested to utilized modern communication channels by all federating units to ensure in time action on trigger information to safeguard public health. It was agreed by all the participants that prompt and effective communication is very crucial for implementing an proficient Rapid Alert and Recall System to removal of SF product from markets. 

      7. Practical Exercises The afternoon session involved hands-on practical exercises. Participants were divided into groups and tasked with case studies for different hypothetical scenarios. Case studies and simulations illustrated the effective collaboration between all the relevant stakeholders. This interactive exercise encouraged teamwork and allowed attendees to apply the concepts learned throughout the day.

      8. Concluding Remarks and Distribution of Certificates Director Pharmaceutical Evaluation & Registration (PE&R) concluded the workshop with his closing remarks on appreciating the active participation from all regulatory entities and QCLs across Pakistan. The certificates of participation were distributed among the participants at the end of session.  

      Draft Format for Submission of Data under the Ethical Marketing to Healthcare Professionals Rules 2021.

      Asad Ullah Drugs, General, Notifications

      The Ethical Marketing to Healthcare Professionals Rules have been notified vide SRO 1472(I)/2021 on the 12th of November 2021 by the Drug Regulatory Authority of Pakistan. These rules have been promulgated to make the interaction between companies and healthcare professionals transparent, free from corrupt practices and to facilitate medical decisions making in the best interest of the patient.

      The aforementioned rules require therapeutic goods companies to submit marketing expenditure details under rule 14(2) and annual compliance certificate under rule 13(h). Subsequent to the notification of these rules, DRAP has drafted an implementation strategy which requires systematic data submission.

      The implementation strategy is aimed at harmonized data submissions by stakeholders in a systemic manner, we have drafted followings formats for data submission:-

      Comments from therapeutic goods companies, healthcare professionals and relevant stakeholders are invited on the draft documents within 15 days. These comments along with justification are to be submitted using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to drap.pharmacy∂gmail.com, copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Islamabad.

      Rapid Alert: Drug Product; Suspected increase in the availability of falsified versions of Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) in the markets.

      Asad Ullah Recall Alerts , ,
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      Rapid Alert

      Suspected Falsified GLP-1 Receptor Agonists

      DRAP Alert NoNo  I/S/07-23-24
      Action Date12th July 2023
      Target Audience1. Regulatory Field Force
      2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics, etc.
      3. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
      4. Patients, Caregivers, and General Public.
      Problem StatementGlucagon-like Peptide 1 Receptor Agonists (GLP-1-RA) are a class of Pharmaceuticals indicated to manage Diabetes type II. In Pakistan, only a single brand i.e. Ozempic injection manufactured by Novo Nordisk is registered by DRAP currently and is available as a “prescription only” product.

      It is reported that there has been a surge of online information promoting the use of GLP-1 RA products for weight loss which is its unapproved use and this situation is encouraging risky procurement behaviors. Numerous online sources offer GLP-1 RA products for sale without requiring a prescription. The quality and safety of these medical products manufactured and distributed in poorly controlled environments (such as the internet) cannot be assured.

      Due to the stated reasons, an increased demand resulting in a global shortage of these products has risen which may create environments favorable for the availability of falsified medical products. Reports have been received by WHO regarding an increase in the availability of falsified GLP-1-RA products in the past six months. It is possible that several versions of falsified GLP-1 RA – regardless of the brand name – are in circulation and available online.

      Therapeutic Goods Affected:-GLP-1 receptor agonists
      Products containing the following active ingredients:-
      -semaglutide
      -exenatide
      -liraglutide
      -dulaglutide
      -lixisenatide
      Threat to Public HealthFalsified medical products have been known to lack efficacy and/or cause toxic reactions. They are neither approved nor controlled by DRAP and may have been produced in unhygienic conditions by unqualified personnel, contain unknown impurities, and are sometimes contaminated with bacteria. It is also possible that people living with diabetes type II who miss treatment due to the unavailability of GLP-1-RA products may also suffer clinical consequences.
      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 products.

      -Endocrinologists and Pharmacists present at healthcare facilities are requested to remain vigilant and inform patients of procuring medical products only from authorized channels.

      -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 ConsumersTo ensure authenticity, consumers should always obtain medical products from authorized licensed pharmacies /outlets. The authenticity of these products should be carefully checked and If the consumer has any doubt, advice must be sought from your pharmacist.

      In case a consumer has experienced any problem related to taking or using these drug product(s), they should cease the use of the product in question immediately and contact their Physician or Pharmacist and should also report the incident to the Drug Regulatory Authority of Pakistan.

      Career Opportunities: Applications are invited for various positions.

      Ijaz Mustafa Careers
      Career Opportunities: Applications are invited for various positions.

      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.

      The recruitment for vacant positions is in line with DRAP Employee Service Regulation 2015 and vacancies are advertised as per posts approved taking into account the needs of the Authority.  

      Details of Vacant Positions advertised are as below.

      Position Name
      and Scale**      		No. of vacanciesDivision / Office / CadreMax. Age Limit*Qualification/Experience
      Director (RO-15)1Budget & Accounts Division47 Years View Advertisement
      View Corrigendum
      Director (RO-15)1Legal Affairs Division47 Years
      Director (RO-15)1Technical Cadre47 Years
      Director (RO-15)1Administration / HR & Logistic Division47 Years
      Assistant Director (RO-12)1Management Information System Division30 years
      Assistant Director (RO-12)4Legal Affairs Division30 years
      Assistant Director (RO-12)50Technical Cadre30 years
      Assistant Bacteriologist / Assistant Microbiologist (RO-11)2CDL Karachi30 years
      Stenotypist (RO-10)4DRAP, Islamabad30 years
      Data Entry Operator (RO-09)8DRAP, Islamabad25 years
      Electrician (RO-05)1CDL Karachi30 years
      * Max Age Limit Relaxation will be applicable as per Federal Government Policy.
      **RO: Regulatory Officer

      How to Apply:-

      -Please visit the following link: http://etc.hec.gov.pk for online registration.

      -In case of any difficulty during the online registration, please visit onlinehelp.hec.gov.pk or visit HEC Secretariat, or contact HEC regional offices for guidance.

      -Application submission comprises two steps; profile completion using the “My Profile” section and application submission using the “Test Name” link on the menu panel in the left-hand sidebar of the online portal.

      -Only SUBMITTED applications will be considered for the Test and applications in SAVE or INCOMPLETE mode will not be entertained.

      How to Pay Test Fee

      -Test Fee is to be deposited via 1Link/1Bill Invoice participating Banks/ATM/Internet Banking/Mobile Banking/Easypaisa/JazzCash/Upaisa.

      The detail of the fee is as under:-

      PositionTest Fee (PKR)
      Director (RO-15)2500/-
      Assistant Director (RO-12)1500/-
      Assistant Bacteriologist /
      Assistant Microbiologist (RO-11)      		1000/-
      Stenotypist (RO-10)1000/-
      Data Entry Operator (RO-09)1000/-
      Electrician (RO-06)600/-

      -Once you have selected 1link 1bill Invoice payment service. Open /sign into your mobile app and click on Bill payment or payment services (as per your mobile banking app options).

      -Click on 1Bill Invoice payment services and enter the consumer number generated by the ETC portal. Once you see the details, pay the amount.

      -After depositing the fee through 1link 1Bill Invoice, click on Verify Online Payment on ETC Dashboard.

      -The test fee is non-refundable and non-transferable.

      -The candidates must get their queries/complaints resolved before the closure of the web registration portal. Queries/complaints handling beyond the registration deadline is denied by the system due to logistics/security reasons.

      Note: It is Mandatory to bring your Original Roll Number Slip, Original  CNIC, Original Passport, and Paid Fee Receipt via 1 link otherwise candidate will not be allowed to sit in the exam.

      Decisions of 58th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

      Asad Ullah Medical Devices Board

      The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 58th 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 / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.

      Defered-letter-of-58th-meeting-of-MDBDownload