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Year: 2023

Rapid Alert; Drug Product: Unregistered and Falsified Hyp-Rho-D injection (Rho(D) immune globulin Injection

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Rapid Alert

Unregistered and Falsified Hyp-Rho-D injection (Rho(D) immune globulin Injection

DRAP Alert NoNo  I/S/08-23-30
Action DateAugust 02, 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 Provincial Inspector of Drugs in Mansehra obtained a sample of the Hyp-Rho-D Injection from M/s. Abdullah Medical Store, located inside the Naseem Surgical Center, Upper Chennai Abbottabad Road, Mansehra. This particular product is not registered with the DRAP and is suspected to be falsified.
The product detail as under: –

Therapeutic Goods Affected:-

SrProduct NameCompositionBatch #Mfg. DateExp. DateManufactured by
(as stated on label)		Remarks
1Hyp-Rho-D Injection
 
Registration No: Nil
Rho (D) immunoglobulin (Human) for injection09181943—Aug-2024M/s. Woolmar Chemical Corporation, USA.

Importer / Distributor:
Ms. Zaryab Traders Lahore.		The product is not registered and is also suspected to be falsified.
Risk Statement:The product claimed to contain immune globulin (anti-D immune globulin or RhIG), which is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. The claimed product is unregistered which infers that the quality and safety attributes of the product are not accepted and approved by DRAP. Unregistered Injectable products may cause severe and lethal adverse effects as the safety and quality attributes 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.

Rapid Alert: Medical Devices; Unregistered Intravenous Medical Devices in the market

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Rapid Alert

Unregistered Intravenous Medical Devices in the Market

DRAP Alert NoNo  I/S/08-23-31
Action Date10th August 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 Medical Device Rules 2017 provides the regulatory framework for medical devices in the country. SRO 224(I)/2023 dated 27-02-2023 extended the transition period for the registration of medical devices to licensed importers and manufacturers as per risk-based classifications. However, medical devices specified in Schedule D and E of this SRO are always mandatory to be registered with DRAP before marketing in the country. DRAP has received reports/complaints that some unregistered medical devices (e.g., IV cannulas, infusion sets, syringes, etc.) are being proliferated in the open market.

The product detail as under: –

Therapeutic Goods Affected:-

SrProduct NameManufacturer/importer
(as stated on label)		Illustration of unregistered medical devices
1Euro Plus Infusion SetApex Medical Devices

2Chiron Infusion SetNot mentioned
3Health Plus Infusion SetNot mentioned
4O’Divine Infusion SetNot mentioned
5Cath-Tec I.V CannulaNilhol Enterprises
East Lane Business Park Wemby, UK
6Healthflon I.V. CannulaHealthylife medical equipment Trading,
Alfajar Business Centre, airport road, Dubai, UAE
Risk Statement:The use of unregistered medical devices poses significant risks to patients as they may not meet the necessary standards of safety, quality, and performance. Such medical devices can be nonsterile, or their sterility can be compromised from damage during shipping and storage. The hazards associated with the use of unregistered medical device includes inaccurate or unreliable results, Infection or other adverse reactions, Failure of the device’s intended purpose, and Injury or death.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate these products where available. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying these products. Any remaining stock should be quarantined immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) in order to ensure the removal of these unregistered products.
Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these products.

-Procurement staff in healthcare settings must obtain the registration status of medical devices falling in schedules D and E of the Medical Device Rules, 2017, from the suppliers. It’s imperative to note that authorized manufacturers and importers hold the exclusive right to provide medical devices in the market.

-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 stop using this product and shall 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 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.

Relocation of Manufacturing Units from Residential Area to Industrial Area

Ijaz Mustafa General, Regulatory Updates

DRAP issued directions to the manufacturers vide No.F.1-78/2018-DD(H&OTC)(Pt) dated 2nd September, 2019 for those whose manufacturing units were situated in the residential area to relocate their manufacturing sites to the industrial areas to ensure the environmental safety and protection of public health. Following DRAP guidelines, another large manufacturer of alternative medicines has relocated its facility from a residential to an industrial area. Consequently, EEC has cancelled previous enlistment certificates (Form-6 and Form-7) and issued revised enlistment certificate for the new manufacturing site in the residential area.

Revocation-Hamdard-LabDownload

Developing National Medicine Policy; Meeting of Technical Working Group on 1-2 August 2023 at Islamabad

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Developing National Medicine Policy; Meeting of Technical Working Group on 1-2 August 2023 at Islamabad

National Medicine Policy is a high-level guiding document that outlines the national perspective and strategies to promote health sector for enhancing national capacities with the aim to increase access to and rational use of high quality and affordable medicines and health products in the country.

DRAP has significance role in the development and implementation of National Medicine Policy. As a country, we need to undertake measures to make drugs accessible to our populations and future generations through ensuring high-tech manufacturing capabilities, their proper distribution and having trained professional workforce to prescribe and administer these drugs. With the growing population, our needs for essential drugs are also growing for treating various diseases. To meet the objective, a holistic approach is needed in which all the stakeholders work for ensuring that patients get access to quality assured, safe and effective drugs.

TWG Meeting on National Medicine Policy, 1-2 Aug, 2023 at Islamabad

A National Medicine Policy is a crucial framework which provides strategic directions and guidelines for safe, effective, and accessible use of drugs within a country. It has huge significance as it impacts the public health directly. A well-developed NMP ensures equitable access to essential medicines and contributes to disease management and control.

2023 ISPE Singapore Affiliate Conference & Exhibition, 23-25 August 2023 (Complimentary Registration for Regulators and Pharma Manufacturers)

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The ISPE Annual Conference & Exhibition, 2023 for Pharmaceutical and biomanufacturing professionals is happening from 23-25 August, 2023 at Suntec, Singapore & online. This conference is aimed at highlighting global and regional best practices in process, technology and innovations. International and Asian manufacturers, regulatory agencies and subject matter experts share knowledge from manufacturing facility design to finished product.

The conference is known as showcasing latest technologies and services, workshops and discussion sessions. This year, participants can join the conference both in-person or virtually.

lSPE Singapore Affiliate Conference & Exhibition, 23-25 August 2023

Online & Suntec Singapore

Visit Conference Website for more information.

Free Registration for Regulators, Pharma and Biomanufacturers

The organizers of ISPE Conference and Exhibition, 2022 have offered free registration for regulators and industry professionals who can get register for free to attend the ISPE Singapore conference in august, either online or in person.

Interested applicants are required to fill out the google form provided on the this link or by open the below the link in the browser https://www.cognitoforms.com/ISPESingapore1/ISPESingaporeConferenceExhibition2023ComplimentaryDelegatePass
Please note that these complimentary delegate passes are subject to approval by the organizer and may be limited; 

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

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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

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    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

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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

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      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.