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Year: 2022

Medicine Safety Week 2022; DRAP’s Call to Healthcare Professionals and Patients to Report Suspected Adverse Reactions of drugs and vaccines.

Asad Ullah News & Updates, Pharmacovigilance, Press Releases

The seventh annual Social Media Campaign #MedSafetyWeek was launched on the 7th of November, 2022 by the National Pharmacovigilance Centre, DRAP, which was observed until 13th November 2022, to encourage everyone to report suspected side effects of medicines. The International campaign was led by the Uppsala Monitoring Centre (UMC), the World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring.

This year’s global campaign involved medicines regulators from 81 countries and focused on the key role of every healthcare professional, patient, and caregivers who reports a suspected side effect and contributes to using medicines safely. This campaign was supported by the members of the International Coalition of Medicines Regulatory Authorities (ICMRA)

#MedSafetyWeek 2022

Every report to the National Pharmacovigilance Centre, DRAP helps to improve the safety of medicines for all patients.

People are encouraged to report suspected side effects of medicines as part of the global #MedSafetyWeek social media campaign

Why Reporting is required?

All medicines may cause side effects in some patients, so there are steps in place to continuously monitor their safety after they are placed on the market. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Regulatory bodies operate systems to detect and analyse those side effects and prevent harm to future patients.

The National Pharmacovigilance Centre, DRAP, collects, organises, and investigates reports of suspected side effects / Adverse effects.

By reporting suspected side effects, you are actively participating in identifying emerging safety issues, so that DRAP can take action when necessary and protect you and others from harm.

Every Report is important for us

Every report made by a patient, a healthcare professional, or a caregiver plays a key role in gaining more knowledge about the benefits and risks of medicines in clinical use and allows action to be taken to minimize risks and can result in better tailored prescribing advice, which can improve patient outcomes.

Patients / care givers and all healthcare professionals can report suspected side effects to the National Pharmacovigilance Centre, DRAP. You can submit a report in many ways:

Are you a Pharmacist?

You are the first person patients go to when they have questions about their medicines.  Please report any new side effects of a medicine via the [Med Safety App & E reporting https://primaryreporting.who-umc.org/PK 

DRAP Signed MoU with Pakistan Single Window to Foster Cooperation

Asad Ullah News & Updates, Press Releases
DRAP Signed MoU with Pakistan Single Window to Foster Cooperation

The Islamabad 11th Nov, 2022; Drug Regulatory Authority of Pakistan signed a memorandum of understanding with the Pakistan Single Window (PSW) in a ceremony held on 11th Nov 2022 at Islamabad. This MoU is aimed at enhancing cooperation among two departments through digital integration of IT System of PSW with the regulatory processed of DRAP. This will enable therapeutic goods industry to utilize an integrated electronic platform for import and export of raw materials and finished products using single entry point.  PSW will support international trade of therapeutic goods by recognizing standardized information and documents on an online platform which will fulfill all import, export, and transit regulatory requirements.

Speaking to the participant at the ceremony, Mr. Asim Rauf, CEO DRAP lauds the efforts and contribution of PSW team and stated that DRAP is continuously transforming its regulatory operations into IT based electronic solutions and various initiatives are underway to revamp drug regulatory system in the country. DRAP is one of the largest organizations in public sector that has fully replaced the manual filling system with an electronic office module for intradepartmental communication and decision making. This MoU will mutually benefit both Regulators and Industry by enabling one window working environment in electronic format which support compliance with all regulatory requirement and processes for cross border trade of therapeutic goods. DRAP and PSW will continue to support each other for provision of more facilitating regulatory environment to industry. In future, DRAP will also integrate licensing and registration systems for therapeutic goods with PSW.         

Recall Alert: Drug Product; Moxtrex 400mg Tablets (Batch # 850) by M/s Gillman Pharmaceuticals, Hattar, Khyber Pakhtunkhwa

Asad Ullah Product Recalls, Recall Alerts

Recall Alert

DRAP Alert NoNoII/S/10-22-32
Action Date3rd November 2022
Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Moxtrex 400mg Tablets,
Active Ingredient(s): Moxifloxacin
Company: M/s Gillman Pharmaceuticals, Hattar.
Batch No. 850
Manufacturing Date: 06-2022
Expiry Date: 06-2024
Problem / Issue Drug Testing Laboratory (DTL) Rawalpindi has analyzed the samples of Moxtrex 400mg Tablets manufactured by M/s Gillman Pharmaceuticals, Hattar, KPK and declared the batch No. 850 as “substandard” based on the analysis report.
Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

-Adverse reactions or quality problems experienced with the use of 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) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

-All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
    Moxtrex-400mg-TabDownload

    Recall Alert: Drug Product; Ceficure 400mg Capsules (Batch # C-737) by M/s Max Pharmaceuticals Islamabad

    Asad Ullah Product Recalls, Recall Alerts

    Recall Alert

    DRAP Alert NoNoII/S/10-22-30
    Action Date2nd November 2022
    Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
    2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
    3. General Public
    Product(s) Affected Ceficure 400mg Capsules,
    Active Ingredient(s): Cefixime
    Company: M/s MAX Pharmaceuticals, Islamabad.
    Batch No. C-737
    Manufacturing Date: 06-2022
    Expiry Date: 05-2024
    Problem / Issue The Drug Testing Laboratory (DTL), Rawalpindi has analyzed the sample of batch No. C-737 of Ceficure 400mg Capsule manufactured by M/s. Max Pharmaceutical, Islamabad, and declared it as “misbranded” drug product.
    Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

    -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

    -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

    -Adverse reactions or quality problems experienced with the use of 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) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

    -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
      Ceficure-cap-Recall-AlertDownload

      Recall Alert: Drug Product; Telsarta 40mg Tablets (Batch # 2B151) by M/s PharmEvo Pharmaceuticals Pvt Ltd. Karachi

      Asad Ullah Product Recalls, Recall Alerts

      Recall Alert

      DRAP Alert NoNoII/S/10-22-31
      Action Date2nd November 2022
      Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
      2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
      3. General Public
      Product(s) Affected Telsarta 40mg Tablets,
      Active Ingredient(s): Telmisartan
      Company: M/s PharmEvo Pharmaceuticals Pvt, Ltd. Karachi
      Batch No. 2B151
      Manufacturing Date: 02-2022
      Expiry Date: 01-2024
      Problem / Issue Drug Testing Laboratory (DTL) Rawalpindi has analyzed the samples of Telsarta 40mg Tablets manufactured by M/s PharmEvo Pharmaceuticals Pvt Ltd, Karachi and declared the batch No. 2B151 as “substandard” based on the analysis report.
      Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

      -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

      -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

      -Adverse reactions or quality problems experienced with the use of 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) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

      -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
        Telsarta-AlertDownload

        Minutes of 1st Meeting of Pharmacovigilance Risk Assessment Expert Committee (PRAEC) held on 12-October, 2022

        Asad Ullah Meeting Minutes, Pharmacovigilance RAE Committee ,

        1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) was held in the Committee Room of the Drug Regulatory Authority of Pakistan (DRAP) on the 12th of October, 2022. The minutes of meeting are attached hereunder:-

        Minutes-of-1st-meeting-of-PRAEC-24-10-2022-FinalDownload

        Suspected Falsified Alert; Drug Products; Suspected Anti-D Immunoglobulin Injection in the market

        Asad Ullah Recall Alerts, Regulatory Updates

        Rapid Alert

        DRAP Alert NoNoI/S/10-22-29
        Action Date28th October 2022
        Target Audience1. Regulatory Field Force
        2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
        3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions
        4. General Public
        Problem StatementDRAP received a complaint regarding the presence of following suspected product in the market. This product is not imported and marketed by the authorized registration holder and neither DRAP has issued import clearance for this product. National Control Laboratory for Biological has also not issued any lot release to this product.
        SrProduct NameCompositionBatch #Manufactured by (as stated on label)
        101 IMMUNORHO 300µg (1.500iu)
        (PFS; Pre-filled syringe)         		Human anti-D immunoglobulinM05W25212M/s. KEDRION BIOPHARMA.
        Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The remaining stock should be quarantine 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 suspected products.
        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 above-mentioned products.

        -Adverse reactions or quality problems experienced with the use of these 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 Consumers-Consumers 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 Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

        -All therapeutic goods must be obtained from the 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.
        Pictures of Suspected falsified product
        immunorho-safety-alert-revisedDownload

        Regulatory Update / Advisory; Recall of Targocid 200mg powder for solution for injection/infusion or oral solution in UK

        Asad Ullah News & Updates, Recall Alerts, Regulatory Updates

        Date:   31st October, 2022

        Target Audience: –  

        • Healthcare Professionals- Physicians, Pharmacists, and Nurses.
        • General Public

        Problem or Issue: –

        Sanofi UK has initiated an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution (Batch Number 0J25D1 and Batch Number 0J25D2). Reason for recall is the out of specifications results obtained for bacterial endotoxins in the retained samples.

        However, both of these batches were not imported or marketed in Pakistan by the authorized registration holder company, hence, Pakistan’s market will not be affected by this recall operation.

        Nonetheless, DRAP has directed registration holder company to test the retaining samples of other batches which are supplied in Pakistan to ensure that problem is not extended beyond the identified two batches.  

        Advice for healthcare professional: –

        Healthcare professionals should be aware of the clinical symptoms related to the potential risk to patient health; a high temperature (fever) or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state – such as confusion or disorientation, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhea.

        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.  Further information on how to report a problem to DRAP is available on this link.

        Advice for general public: –

        Since, these affected batches have not been imported or supplied in Pakistan by the marketing authorization holder, no recall is initiated for this product in Pakistan. These these batches were supplied and being recalled in the UK market only. However, if any person has carried these affected batches for their personal use they are advised not to consume it, and consult their healthcare provider immediately.

        ADVISORY-TARGOCID-final-revisedDownload