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Month: February 2023

Recall Alert: Drug Product; Capex 500mg Tablet (Batch# 2040006) by M/s. Rotex Pharma, Islamabad

Asad Ullah Recall Alerts

Recall Alert

DRAP Alert NoNoI/S/04-23-23
Action Date16th February 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 Capex 500mg Tab
Composition: Capacetiabine
Manufactured by: M/s. Rotex Pharma, Islamabad
Batch No. 2040006
Problem / Issue DRAP received a complaint that a drug product Capex 500mg Tab contains a hair punch within the tablet, which shows adulterated quality which may compromise the quality of drugs.
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 product batch. 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 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 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 experienced any problem that may be related to taking or using this product.

-All drug 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.

    Proposed Amendments in the Rules: Stakeholders Comments are invited on Draft Amendments in the Drugs (Licensing, Registering & Advertising) Rules 1976 and the Medical Device Rules, 2017

    Asad Ullah Drugs, Medical Devices, Notifications

    The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976 and the Medical Device Rules, 2017. These draft amendments are herby notified seeking comments from stakeholder.

    Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification using prescribed format, via email to aamar.latif∂dra.gov.pk, or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.

    Notification-of-Draft-Amendment-in-Rule-30-of-the-Drugs-LRA-Rules-1976-16.02.2023Download
    Notification-of-Draft-Amendment-in-Rule-19-of-the-Medical-Devices-Rules-2017-16.02.2023Download

    Lists of Applications for Provisional Enlistment of Alternative Medicines and Health Products

    Ijaz Mustafa Alternative Medicines, General

    Following is the provisional list of applications are received for provisional enlistment of products with the Division of Health & OTC, Drug Regulatory Authority of Pakistan, Islamabad under provisions of SRO 412 (I)/2014 dated 27-5-2014. Applicant firm are requested to furnish comments with respect to submitted applications within 30 days of the uploading of this list, if any. The comments received within 30 days of the publication of this list will be given due consideration, after which a final list will be uploaded on the website. Comments received after due date shall not be entertained. The processing of these applications under provisions of above said SRO will be dealt on First Come First Serve basis as per sequence of date mentioned against each application

    These lists are prepared according to types of products and categories of applicant’ firms, as under:-

    2021_-_Date_wise_Provisional_List_of_Application_for_Provisional_Enlistment_of_Homeopathic_productsDownload
    2021_-_Date_wise_Provisional_List_of_Applications_for_Provisional_Enlistment_of_Herbal_Unani_productsDownload
    2021_-_Date_wise_Provisional_List_of_Applications_for_Provisional_Enlistment_of_Nutraceutical_products_Download

    Cancellation of Enlistment Certificates (Form-6 and Form-7) of two alternative products manufacturers’ for non-compliance to minimum regulatory requirements.

    Ijaz Mustafa Alternative Medicines, General

    Enlistment Evaluation Committee (EEC) has cancelled the provisional enlistment certificates of two (02) alternative products manufacturing companies for non compliance to minimum manufacturing requirement as per applicable rules. The Committee also cancelled / revoked all the product enlistment certificates issued on the name of these two firms. The cancellation letters have been issued by the Division of Health & OTC to the all concerned authorities.

    Ms._Convell_Labs_SwatDownload
    W.Welkins_Rawat.Download

    DRAP issued Consolidated Guidance Document on Good Manufacturing Practices for Manufacturing Sites of Drugs.

    Asad Ullah Drugs, Licensing and Inspections, News & Updates, Regulatory Updates

    To ensures the quality of drugs and compliance with its Current Good Manufacturing Practice (cGMP), DRAP monitor the manufacturers to ensure compliance to minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.  These Good Manufacturing Practices are intended to make sure that a product is safe for use, and meet the prescribed standard of quality.

    Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976 provides detail requirements on Good Manufacturing Practices (GMP), however, DRAP intended to provide a compiled GMP guidance document stipulating Drug Regulatory Authority of Pakistan’s (DRAP) expectations on GMP from pharmaceutical & biological drugs manufacturers.

    This Guideline is intended to provide guidance regarding the Good Manufacturing Practices (GMP) for the manufacturing of pharmaceutical & biological drug in accordance with the Drugs (Licensing, Registering & Advertising) Rules, 1976, under the Drugs Act, 1976, the good manufacturing practices aim at ensuring that:

    1. Products are consistently produced and controlled to the quality standards appropriate to their intended use
    2. Products are manufactured as required by the marketing authorization or product specification; and
    3. All those risks have been diminished that are inherent in any pharmaceutical / biological production operation, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products.

    This document will help industry and Regulators to conform the requirement of GMP for production, verification, and validation of manufactured products and ensure that they are effective and safe.

    GMP GUIDELINES (DRAP-GMP)Download

    Notification: Directions of Registration Board on Labeling Requirements of Drug Products to Comply Pharmacopeial Specifications for Dissolution Testing

    Asad Ullah Drugs, Notifications, Regulatory Updates , , ,

    Registration Board in its 323rd meeting observed that various USP monographs for drug products prescribe more than one dissolution tests and that the pharmacopoeia in such cases recommends that “When more than one Dissolution Test is given, the labeling states the Dissolution Test used only if Test 1 is not used.”

    Keeping in the USP labeling requirements narrated above and to comply to the Pharmacopeial specifications, the Board decided as under:

    “The manufacturer shall mention the dissolution test Number on the secondary packing / unit carton of product for dissolution tests No 2,3 or 4 as per requirement of USP otherwise it would be presumed that dissolution test No.1 shall be performed on the finished product.”

    Accordingly, the decision of Registration Board is circulated for information and compliance by relevant stakeholders / manufacturers.

    DRAP and WHO collaborated to hold a “Two-Day Consultative Meeting on WHO AWaRe Classification of Antimicrobials in the National Essential Medicine List (NEML) of Pakistan”

    Asad Ullah Events
    DRAP and WHO collaborated to hold a “Two-Day Consultative Meeting on WHO AWaRe Classification of Antimicrobials in the National Essential Medicine List (NEML) of Pakistan”

    Access, Watch, and Reserve (AWaRe) classification was introduced by the World Health Organization in 2017 for strengthening antibiotic stewardship and controlling antimicrobial resistance at the national level. This also includes in WHO GPW 13 indicators of antibiotic use. AWaRe is a relatively “easy” tool that offers more than overall antibiotic use or more conventional classifications.

    WHO country office, in Pakistan, has been facilitating the development of Pakistan’s first “Evidence-based AWaRE classification of essential antibiotics” online active engagement of stakeholders. In the past two years, national experts in the field and consultants were engaged on multiple occasions through online and face-to-face meetings to develop the needful tools, formulate a comprehensive desk review, and collect the indigenous AMR data with support of NIH. The first consultative meeting of the process was held on 29th April 2021 and was attended by more than twenty participants from federal, and provincial levels with representation from both public and private sector.

    Drug Regulatory Authority of Pakistan in collaboration with Ministry of National Health Services, Regulation and Coordination convened the final consultative meeting for development of the AWaRe classification of antibiotics for Pakistan. The meeting participants included the representatives from the M/o NHSR&C, DRAP, World Health Organization, National Institute of Health, Healthcare Commissions and National AMR surveillance program leads at federal and provincial levels, and the AMR sentinel sites. Leading national experts from the field of microbiology, infectious diseases, and other specialties including pharmacists, nurses, academicians, and public health professionals and epidemiologists were invited to ensure maximum contribution from the stakeholders.

    The developed list will act as a guiding principle for designing institutional antibiotic policies and act as a stepping stone to achieve control of the growing antimicrobial resistance in the country.