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Year: 2024

Rapid Alert: Falsified Rhophylac 300mcg PFS, Human Anti-D Immunoglobulin Injection Identified in Market

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo I/S/11-24-42
Action Date07th November, 2024
Target Audience·         National Regulatory Field Force.
·         Distribution, Pharmacies and Medical Stores
·         Healthcare Professionals – Physician, Pharmacist, Nurses
· Maternal and Child Health Centres
Problem StatementM/s Hakimsons Impex (Private) Ltd, Karachi, has notified DRAP regarding the presence of falsified Rhophylac 300mcg PFS in the market across Pakistan and also referred to letter No. 438/PDI-ZR/PWR, received from Provincial Inspector, Peshawar for verification of the sample. The packaging of the product shows two different batch numbers while barcode scan displays another batch number.
Product nameBatch/Lot No.Manufacturer Name
(as per label) 		Mfg. dateExp. date
Rhophylac 300mcg PFS,
Human Anti-D Immunoglobulin		P100547971
P100644011
­­­­
Barcode Batch:
P100585096		M/s CSL Behring AG,
Wankdorfstrasse 10,
CH-3000 Bern 22,Switzerland. 		10-202309-2026
Threat to Public HealthThe Anti-D immunoglobulin is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Falsified Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the products are unknown
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities in market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered product
Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link.

Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link
Advice for ConsumerConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using these products 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.

Decisions of 72nd Meeting of Medical Device Board; Deficiency letters for Medical Devices Applications

Asad Ullah Medical Devices Board, Uncategorized

The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 72nd meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.

72nd Meeting MDBDownload

Implemmentation of Industry E-Reporting System for Reporting of Adverse Drug Reactions by Registrtaion Holders

Asad Ullah Drugs, Pharmacovigilance

The Drug Regulatory Authority of Pakistan (DRAP) has launch the Industry e-reporting System for Individual Case Safety Reports (ICSRs). This new system, developed in collaboration with the Uppsala Monitoring Centre (UMC), aims to simplify and streamline the submission process for registration holders, including manufacturers and importers of therapeutic goods. The National Pharmacovigilance Centre (NPC), established under the Division of Pharmacy Services, will oversee this initiative to ensure the safety of therapeutic goods, in line with the Pharmacovigilance Rules, 2022.

Since its inception, DRAP has been committed to promoting transparency and facilitating document submission through various tools. The new Industry e-Reporting System will allow registration holders to submit ICSRs via two modules: E2B XML submission and manual data entry for non-E2B pharmaceutical companies. Access to this system will be secure, with two accounts provided per registration holder.

Following a successful pilot project with a selected number of registration holders, DRAP is now extending the system’s scope to all registration holders. Starting from 8th November 2024, all future ICSRs must be submitted through this system. For further guidelines, please refer to the “Industry e-Reporting Manual for Registration Holders” available on the DRAP website.

We appreciate your cooperation in ensuring the safety and efficacy of therapeutic goods in Pakistan.

Implemenation letter of Industry e-reporting systemDownload

Directive of Registartion Board; Submission of Summary of Product Characteristics (SmPC), Prescribing Information(PI) and Patinet Leaflet(PIL)

Asad Ullah Drugs

Registration Board in 340th meeting held from 1st October to 2nd October 2024, directed applicants to submit the Summary of Product Characteristics (SmPC) including Prescribing Information (PI) along with Patient Information Leaflet (PIL) against section 1.5.14 of CTD for the Finished Pharmaceuticals Product (FPP).

It is hereby circulated for compliance and information of all stakeholders.

CIRCULAR-SmPC-PILDownload

Career Opportunities: Applications are invited for Various Positions in DRAP

Ijaz Mustafa Careers, General

The Drug Regulatory Authority of Pakistan (DRAP) employs over 500 people from a range of educational backgrounds, who have the skills and experience to perform regulatory operational services under the DRAP Act 2012. These include professionals both technical (qualifications in medicine and pharmacy-related sciences, etc.) and non-technical (qualifications in law, information and communication technology, accounts, human resources management, etc.)

DRAP is mandated to provide effective coordination and enforcement of The Drugs Act, 1976, and harmonization of inter-provincial trade and commerce of therapeutic goods. Being the national regulatory body for therapeutic goods, DRAP performs various regulatory functions of therapeutic goods including licensing of establishments, product registrations/marketing authorizations, pharmacovigilance, post-market surveillance and market control, regulatory inspections, laboratory testing, clinical trials oversight and lot release of biologicals.

Details of Vacant Positions advertised are as below.

46×4-and-48×4-Ad-25-10-24Download

Voluntary Recall Alert: Drug Product; Neo-Pyrolate Injection (Batch # 105B24) Manufactured by M/s Brookes Pharma (Pvt.) Ltd, Karachi.

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/11-24-46
Action Date28th October 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
– General Public
Problem / Issue M/s. Brookes Pharma Private Limited, Karachi, has initiated a voluntary recall of voluntary recall of the following product through public notice. The details of the product are as below:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Neo-pyrolate Injection IV
 
1ml × 10’s		Glycopyrrolate + Neostigmine MethylsulphateBatch No. 105B24
 
Mfg. date: 02-2024
Exp. date: 02-2026		M/s Brookes Pharma (Pvt.) Ltd, Karachi.
Risk Statement:The use of substandard injection may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions.
Action InitiatedThe field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to conduct market surveillance for the detection of the presence and removal of the recalled batches from the market.
Advice for Healthcare ProfessionalsAll pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the mentioned product. The remaining stocks should be quarantined and returned to the supplier/company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 products bearing the affected batch number(s) and should contact 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 the Drug Regulatory Authority of Pakistan/ National Pharmacovigilance Centre..

-All therapeutic 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.