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Safety Alert: WHO Global Alert on Tetracycline Hydrochloride Ophthalmic Ointment USP 1%

Asad Ullah Recall Alerts, Regulatory Updates, Safety Alerts

Safety Alert

Update from WHO Global Surveillance and Monitoring System

Date:28th February 2023
Target Audience:· Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
· International travelers/General Public
· NGO’s/Supply Donations/Humanitarian Medicines
Problem or IssueWorld Health Organization (WHO) issued Medical Product Alert No. N°2/2023 dated 22nd February 2023 which refers to the batches of Tetracycline Hydrochloride Ophthalmic Ointment USP 1%, manufactured by Galentic Pharma (India) Pvt. Ltd, located at R-673, T.T.C. MIDC Rabale, Thane- Belapur Road, Navi Mumbai – 400701, Maharashtra, India Supplied in various countries under various labels.
Visual examination of random samples had shown a range of quality issues with the random samples of the product batches e.g. particles ranging in color, size and shape on the nozzle, in the cap and in the ointment inside each tube, black spots and brown splotches on the inner foil layer of the tube, and phase separation.
DRAP has never authorized sale of any products from Galentic Pharma (India) Pvt. Ltd (Thane Belapur Road, Navi Mumbai, India). These products are neither registered nor available on Pakistan market, however these may have been carried for personal use while visiting other countries.
The manufacturer has initiated a voluntary recall for several batches. The manufacturer has indicated that other batches may be included in the voluntary recall
Potential Hazards:There is currently no established evidence of any adverse events from the affected batches of TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1%. Redness and swollen eyes are common reactions to general use of tetracycline eye ointment. There is currently no indication that the above-mentioned quality issues may give rise to adverse events that are not listed in the product labelling. The affected TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% is supplied in bulk and as a component of various medical kits supplied by some international organizations providing humanitarian assistance.
Advice for healthcare professionals:DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this affected batch of product. Adverse reactions or quality problems experienced with the use of any product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information of reporting problems to DRAP is available on this link.
Advice for patients:Consumers should stop using this product bearing the affected batch number(s) 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.
    Safety-Alert-for-TetracyclineDownload

    All therapeutic goods must be obtained from the licensed pharmacies, and other authorized retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professional in case of any doubt.

    Proposed Amendments in the Rules: Stakeholders Comments are invited on Draft Amendments in the Drugs (Research) Rules, 1978

    Asad Ullah Drugs, Notifications , , ,

    The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Research) Rules, 1978. These draft amendments are herby notified seeking comments from stakeholders.

    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-Amendments-in-the-Drug-Research-Rules-1978-1Download

    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.

    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.