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Rapid Alert: Counterfeit and Unregistered Paracetol 500mg Tablets identified in the Market

Asad Ullah Uncategorized
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Rapid Alert

Falsified and Unregistered Paracetol 500mg Tablets

DRAP Alert NoNoI/S/ 02-20-09
Action Date6th April, 2023
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
3. General Public
Problem StatementDrug inspector Diamer/Astore took the sample of Paracetol 500mg Tablets (Bach No. 470) and sent it to Drug Water and Food Testing Laboratory, GB, for test/analysis, which has been declared as a counterfeit product.

The product detail as mentioned on the label is as under: –

Therapeutic Goods Affected:-

SrProduct NameCompositionBatch #Manufactured by Remarks by Laboratory
1Paracetol 500mg Tablets

Mfg. Date: 11-2022
Exp. date:  11-2024		Paracetamol 470Ms. Roryan Pharmaceuticals (Pvt.) Ltd., Peshawar.The sample is Counterfeit under the Drugs Act 1976 as it resembles with Panadol 500mg Tablets by M/s GSK.
The Product has also been declared Un-Registered By DRAP*.
* Registration Board in its 312th meeting has cancelled the registration of Paracetol 500mg Tablets of M/s Roryan Pharmaceutical Industries Pvt. Limited Peshawar, bearing Registration No. 059421. Cancellation letter was issued on 09-12-2021 vide No. 3-5/2021-RRR (M-312).
Risk Statement:Paracetamol is used for mild to moderate pain including headache, migraine, nerve pain, toothache, sore throat, period pains, and general aches and pains. It is also used to help reduce fever. Unregistered/falsified products may lead to adverse reactions including but not limited to the following:
·         Blood disorders, such as thrombocytopenia and leukopenia.
·         Liver and kidney damage.
· Sub-therapeutic effect regarding fever, inflammation, and pain control.
Action InitiatedThe manufacturer has been directed to immediately recall this product from the market. The Regulatory Field Force has been directed to increase surveillance throughout the supply chain. 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 product(s).

-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 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.

Recall Alert: Drug Product; Micogen-B Cream (Batch#MB-012/22) by M/s. Delux Chemical Industries, Karachi

Asad Ullah Recall Alerts

Recall Alert

DRAP Alert NoNoII/S/03-23-17
Action Date27th March 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 Micogen-B Cream
Composition: Gentamicin, Miconazole and Betamethasone
Manufactured by: M/s. Delux Chemical Industries, Karachi
Batch No. MB-012/22
Manufacturing Date: 11-2022
Expiry Date: 11-2024
Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. MB-012/22 of the product “Micogen-B Cream” as of substandard quality.
Risk StatementDrug Product contains multiple ingredients including Betamethasone, Gentamicin & Miconazole, is indicated for treatment of fungal and bacterial infections of the skin. Impact of use of substandard product on basis of Bio Assay test may leads to sub optimal to no therapeutic effect and may intensify/ flare the existing bacterial and fungal infection.
Action Initiated-The manufacturing company / registration holder has been directed to immediately recall the defected batch of product from the market.

-All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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.
    Micogen-B-Cream-Batch-MB-012-22Download

    Recall Alert: Drug Product; Mefco 50mg/5ml Suspension (Batch# 2J041) by M/s. Eros Pharmaceuticals (Pvt) Ltd., Karachi

    Asad Ullah Recall Alerts

    Recall Alert

    DRAP Alert NoNoII/S/03-23-19
    Action Date29th March 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
    Composition: Mefenamic Acid
    Manufactured by: M/s. Eros Pharmaceutical (Pvt) Ltd., Karachi
    Batch No. 2J041
    Manufacturing Date: 10-2022
    Expiry Date: 10-2024
    Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. 2J041 of the product “Mefco 50mg/5ml Suspension” as of substandard quality.
    Risk StatementMefenamic acid is used to treat mild to moderate pain. Impact of use of substandard product on basis of pH test may significantly altered the solubility and interfere with its absorption.
    Action Initiated-The manufacturing company / registration holder has been directed to immediately recall the defected batch of product from the market.

    -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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-batch-2J041-Eros-PharmaDownload

      Decisions of 56th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

      Asad Ullah Medical Devices, Medical Devices Board

      The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 56th 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.

      Applications for Local Manufacturing

      Defered-Letter-of-56th-Meeting-of-MDB-LocalDownload

      Applications for Import

      Defered-Letter-of-56th-Meeting-of-MDB-ImportDownload

      Stakeholders Comments are invited on the Draft Guidelines for Good Cold Chain Management Practices for Temperature-Sensitive Drug Products

      Asad Ullah Drugs, General, Invitation for Comments , , ,

      The supply chain of Time and Temperature Sensitive Drug Products (TTSDPs) requires constant maintenance of temperature so that the cold chain remains integral to ensure that the product quality is not compromised. Registration holders of TTSDPs including manufacturers, Importers and exporters along with their authorized distributors, are required to provide suitable storage conditions throughout the life cycle of the product under the Drugs (Licensing, Registering & Advertising) Rules, 1976. Similarly, Pharmacies, Medical stores and other authorized sale outlets, and healthcare institutions are also required to provide suitable storage and distribution while dispensing TTSDPs under relevant provincial drug sale rules.

      DRAP has drafted this guidelines to set out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSDPs). These guidelines intended to emphasize the increased importance of pharmaceutical cold chain management as a result of changing product environment, the requirements for Good Storage and Distribution Practices, current regulatory trends, quality management, risk assessment factors, and temperature monitoring system.

      This draft guideline is uploaded on the official website of DRAP dated on 27th March, 2023, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at akbar.ali∂dra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

      Draft_Guidance_on_Cold_Chain_Practices_FormattedDownload

      Decisions of 55th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

      Asad Ullah Medical Devices, Medical Devices Board

      The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 55th 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.

      Applications for Registration of Medical Devices for Local Manufacturing

      Deffered-letters-M-55-LocalDownload

      Applications for Registration of Medical Devices for Import

      Deffered-letters-M-55-ImportDownload

      Decisions of 54th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

      Asad Ullah Medical Devices, Medical Devices Board

      The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 54th 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-MDB-54Download

      Important Notice to Pharmaceutical / Biological Manufacturers and Importers

      Umer Farooq Drugs

      DRAP has deployed an online application management system namely, Pakistan Integrated Regulatory Information Management System (PIRIMS) for processing of regulatory information related to licensing, registration and inspections of pharmaceutical and biological drugs.

      All the Registration Holders of pharmaceutical and biological drug products are directed to update the finished product specifications and validated testing procedures i.e. Pharmacopoeial or in case of non-availability in any pharmacopeia, Innovator / Manufacturer’s Specification,  in the corresponding product profile / details in the PIRIMS at http://pirims.dra.gov.pk. The portal  to perform the above-said activity will remain accessible for thirty days after publication of this notice and afterwards, no request shall be entertained. It is further clarified that after the lapse of the due time for above-said activity, necessary regulatory fee may apply.

      For further information and queries, Registration holders may contact Data Management Cell (DMC) of Pharmaceutical Evaluation & Registration Division through email (dmc∂dra.gov.pk) with regards to guidance for procedures and requirements etc.

      Pakistan Integrated Regulatory Information Management System (PIRIMS)

      PIRIMS enable the regulators and industry to communicate electronically for processing regulatory information related to licensing, registration, inspections procedures for pharmaceutical and biological drugs.

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