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Month: January 2023

Recall Alert: Drug Product; Awahaem Tablets (Batch # 2781 by M/s. Usawa Pharmaceuticals, Rialpur.

Asad Ullah Uncategorized

Recall Alert

DRAP Alert NoNoI/S/01-23-04
Action Date23rd January 2023
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 Awahaem Tablets
Active Ingredient(s): Elemental Iron 100mg & Folic Acid 0.35mg
Company: Ms. Usawa Pharmaceuticals (Pvt.) Ltd., Risalpur
Batch No. 2781
Manufacturing Date: 06-2022
Expiry Date: 06-2024
Problem / Issue CDL Karachi has declared the batch No. 2781 of Awahaem Tablets, manufactured by M/s. Usawa Pharmaceuticals (Pvt.) Ltd., Risalpur as substandard drug product.
Action Initiated-The manufacturing company has been 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.
    Awahem-Tab-Recall-AlertDownload

    Recall Alert: Drug Product; Mefco 50mg/5mL Suspension (Batch # 21053) by M/s Eros Pharmaceuticals, (Pvt) Ltd, Karachi .

    Asad Ullah Recall Alerts

    Recall Alert

    DRAP Alert NoNoI/S/01-23-02
    Action Date23rd January 2023
    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 Mefco 50mg/5mL Suspension,
    Active Ingredient(s): Mefenamic Acid
    Company: M/s. Eros Pharmaceuticals (Pvt) Ltd, Karachi.
    Batch No. 21053
    Manufacturing Date: 09-2022
    Expiry Date: 09-2024
    Problem / Issue CDL Karachi has declared the batch No. 21053 of Mefco 50mg/5mL Suspension, manufactured by M/s. Eros Pharmaceuticals (Pvt) Ltd, Karachi. as substandard drug product.
    Action Initiated-The manufacturing company has been 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.
      Mefco-50mg-Suspension-Eros-PharmaDownload

      Recall Alert: Drug Product; Santodex Opthalmic Ointment (Batch # BJ-082) by M/s Sante (Private) Limited, Karachi .

      Asad Ullah Recall Alerts

      Recall Alert

      DRAP Alert NoNoI/S/01-23-03
      Action Date23rd January 2023
      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 Santodex Opthalmic Ointment,
      Active Ingredient(s): Tobramycin 3mg/g & dexamethasone 1mg/g
      Company: M/s. Sante (Private) Limited, Karachi
      Batch No. BJ-082
      Manufacturing Date: 04-2022
      Expiry Date: 04-2024
      Problem / Issue CDL Karachi has declared the batch No. BJ-082 of Santodex Opthalmic Ointment, manufactured by M/s. Sante (Private) Limited, Karachi as substandard drug product.
      Action Initiated-The manufacturing company has been 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.
        Santodex-oint-Recall-AlertDownload

        Recall Alert: Drug Product; Fenbar 50mg Tablets (Batch # 2752) by M/s Usawa Pharmaceuticals, Risalpur.

        Asad Ullah Recall Alerts

        Recall Alert

        DRAP Alert NoNoI/S/01-23-05
        Action Date25th January 2023
        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 Fenbar 50mg Tablet,
        Active Ingredient(s): Diclofenac Sodium
        Company: M/s. Usawa Pharmaceuticals, Risalpur.
        Batch No. 2752
        Manufacturing Date: 04-2022
        Expiry Date: 04-2025
        Problem / Issue CDL Karachi has declared the batch No. 2752 of Fenbar 50mg Tablet manufactured by M/s.Usawa Pharmaceuticals, Risalpur as substandard drug product.
        Action Initiated-The manufacturing company has been 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.
          Fenbar-50mg-Tab-Recall-Usawa-RisalpurDownload

          Decisions of 53rd Meeting of Medical Device Board (Deficiency letters for Imported Medical Devices)

          Ijaz Mustafa Medical Devices Board, Meeting Minutes

          The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 53rd 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

          Deferred_letter_M-53Download

          Notification: Directions of Registration Board on Reference Product data submissions for conducting Pharmaceutical Equivalence and Comparative Dissolution Profile Studies

          Asad Ullah Drugs, Notifications , , ,

          Registration Board of DRAP has issued a Guidance document for applicants on submission of application on form 5-F (CTD) for registration of pharmaceutical drug products for human use. Submission of data of pharmaceutical equivalence and Comparative Dissolution Profile (CDP) is required under section 3.2.P.2.2.1 (Formulation Development) of Form 5F (CTD).

          In order to further harmonize the submission of such data and ensure data integrity, Registration Board in its 322nd meeting held on 8th & 10th November, 2022 decided as under:

          “Firm shall submit the image/picture/snapshot of the innovator/reference/comparator pack against which Pharmaceutical equivalence / Comparative Dissolution Profile studies have been performed and shall reveal the details of brand name, manufacturer, batch# and expiry date of the innovator/reference/comparator product in the section 3.2.P.2.2.1 (Formulation development) of Form 5F.“

          Accordingly, above decision of Registration Board is hereby notified and circulated for information and compliance by relevant stakeholders / applicants.

          Notification: Directions of Registration Board on the Drug Substance (DS) for Product Development, R&D, and Stability Testing

          Asad Ullah Drugs, Notifications

          The Registration Board of Drug Regulatory Authority of Pakistan grants registration to pharmaceutical and biologicals drug products for human and veterinary use. The Drugs (Licensing, Registering and Adverting), Rules, 1976 as amended requires that applicant shall submit applications for human use on Form 5F (CTD), along with submissions of product development, and stability studies, etc under the relevant modules.

          For these studies, applicants firms have to procure the Drug Substance / Active Pharmaceutical Ingredient (API) from licensed pharmaceutical manufacturers only having valid Good Manufacturing Practices (GMP) Certifications and/or Drug Manufacturing Licenses form the relevant Regulatory Authority of the Country of origin.

          The DRAP Authority, upon the request of Pharmaceutical Manufacturers Association has allowed the manufacturers to acquire Drug Substance / Active Pharmaceutical Ingredient (except controlled Drugs / Substance) from another Drug Manufacturing License (DML) holders which has already imported / procured from an authorized source, only for conducting product development and stability studies to submit application for registration to DRAP on Form 5F. However, all requirements of quality and traceability would be applicable in such cases and will be the responsibility of the manufacture/applicant. Further, the products so manufactured in NO case shall be allowed for commercial sale.

          The directions of DRAP Authority and Registration Board is notified accordingly.