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Regulatory Update / Advisory; Recall of Targocid 200mg powder for solution for injection/infusion or oral solution in UK

Asad Ullah News & Updates, Recall Alerts, Regulatory Updates

Date:   31st October, 2022

Target Audience: –  

  • Healthcare Professionals- Physicians, Pharmacists, and Nurses.
  • General Public

Problem or Issue: –

Sanofi UK has initiated an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution (Batch Number 0J25D1 and Batch Number 0J25D2). Reason for recall is the out of specifications results obtained for bacterial endotoxins in the retained samples.

However, both of these batches were not imported or marketed in Pakistan by the authorized registration holder company, hence, Pakistan’s market will not be affected by this recall operation.

Nonetheless, DRAP has directed registration holder company to test the retaining samples of other batches which are supplied in Pakistan to ensure that problem is not extended beyond the identified two batches.  

Advice for healthcare professional: –

Healthcare professionals should be aware of the clinical symptoms related to the potential risk to patient health; a high temperature (fever) or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state – such as confusion or disorientation, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhea.

Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information on how to report a problem to DRAP is available on this link.

Advice for general public: –

Since, these affected batches have not been imported or supplied in Pakistan by the marketing authorization holder, no recall is initiated for this product in Pakistan. These these batches were supplied and being recalled in the UK market only. However, if any person has carried these affected batches for their personal use they are advised not to consume it, and consult their healthcare provider immediately.

ADVISORY-TARGOCID-final-revisedDownload

DRAP finalizes Guidelines on the Preparation of Summary of Product Characteristics (SmPC)

Asad Ullah Drugs, Regulatory Updates

The Summary of Product Characteristics (SmPC) are the basic information for healthcare professionals on the use of drug products to ensure safety, efficacy and quality, and also provides a basis for preparation of the Patient Information Leaflet (PiL). SmPC describes the set of characteristics of a drug product as determined through the assessment process during registration of a drug product.

SmPC guidelines are intended to provide supportive information for preparation of Summary of Product Characteristics (SmPC) for registration / market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products and Biosimilars.

Rule 26 of the Drugs (Licensing, Registering & Advertising) Rules, 1976, as amended vide S.R.O 713(I)/2018 dated 8th June 2018, under 26(1) section 1.5.14 requires that in order to obtain registration/marketing authorization of drug product, a Summary of Product Characteristics (SmPC) is required to be included in the application dossier. The SmPC is part of drug registration / marketing authorization approval, and its contents can only be changed with the approval of Competent Authority. In this context, Registration Board has deliberated the contents of summary of Product Characteristics for pharmaceutical and biological drug products. This document transforms the decisions and advices of Registration Board into a guidance document for preparation of SmPC with application dossier submission in the CTD module.

The draft guidelines were prepared three years ago and was available on the DRAP’ s website. Stakeholders have submitted their comments on the draft document and accordingly guidelines have been finalized after careful consideration of stakeholder’s comments.

Please click to view the final document, GUIDELINES ON Preparation of Summary of Product Characteristics

For more information on Regulatory Guidelines published by DRAP, please navigate to Publications tabs on our website.

Notification: Applications for Registrations of Pharmaceutical drugs submitted on Form 5/5D requiring submission of Product Stability Data

Asad Ullah Drugs, Notifications, Regulatory Updates ,

Registration Board in 320th meeting held on 29th – 31st August 2022 has issued a direction with regards to the applications received on Form 5 / 5-D for registration of pharmaceutical drugs, which requires submission of stability study data for further processing. The list of such applications is available on official website of DRAP (link).

The decision of Registration Board is notified and attached hereunder for information and compliance by all relevant stakeholders.

Notification-Form-5Download

DRAP issued Guidelines on Management of High Alert Medication

Asad Ullah Pharmacovigilance, Regulatory Updates , ,

DRAP envisions advancement in the healthcare system of Pakistan by working at par with international standards, and best regulatory practices through effective management and regulation of therapeutic goods. The National Pharmacovigilance Centre (NPC) at DRAP issues guidelines from time to time for different activities relating to Pharmacovigilance and promotion of pharmacy services to cater to the needs of different stakeholders.

High Alert medicines are those that have a high risk of causing injury or harm if they are misused or used in error. NPC, DRAP has issued a a Guidelines on Management of High Alert Medication to illustrate recommended practices for safe handling of those drug products that are classified as High Alert Medication (HAM). 

The main objective for issuing this guidance document is to support healthcare professionals working at hospitals and healthcare services providing institutes for ensure safe practices for prescribing, dispensing, administration and monitoring of high alert medication (HAM) and applies to all healthcare settings and healthcare professionals involved in the handling and usage of HAM. The outlined and recommended strategies are intended to educate HCPs, prevent risks associated with HAM, implement safety checks and encourage reporting of Adverse Events /Adverse Drug Reactions. 

This draft guideline was uploaded on the official website of DRAP dated 16th June, 2022 with request of comments submissions by the stakeholders. The National Pharmacovigilance centre, Division of Pharmacy Services has finalized the documents after careful evaluation of the comments and input received from internal and external stakeholder consultation.

Suggestions can be forwarded via email to npc∂dra.gov.pk, copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

click to view the Guidelines on Management of High Alert Medication (Edition 01). For more information related the regulatory guidelines and guidance documents issued by the DRAP please navigate to the Publications > Guidelines tab of our website.

National Task Force (NTF) for Eradication of Spurious and Unregistered Therapeutic goods; CEO DRAP Chaired the meeting of NTF Core Team

Asad Ullah Press Releases
National Task Force (NTF) for Eradication of Spurious and Unregistered Therapeutic goods; CEO DRAP Chaired the meeting of NTF Core Team

On 28th September, 2022; The meeting of Core Team of National Task Force for Eradication of Spurious and Unregistered Therapeutic Goods held on 28th September, 2022 at DRAP, HQ Islamabad. The Chief Executive Officer (CEO) of Drug Regulatory Authority of Pakistan (DRAP) chaired the meeting of Core Team for the National Task Force in light of the recommendation of Senate’s Standing Committee on Ministry of National Health Service, Regulation & Coordination (M/o NHSR&C) today at the DRAP Head Quarters, Islamabad. The Director of Quality Assurance & Lab Testing, DRAP, Director of Licensing, DRAP and All the Chiefs of Drug Inspectorates from across the Pakistan attended the meeting. The CEO, DRAP emphasized on enhancing the collaboration among federal and provincial inspectorate of drugs for market surveillance, ensuring the availability of life saving medicines and mitigation of shortage of medicines. The CEO, DRAP further added the measures to control overpricing and particularly the products for public health emergencies should be focused upon. Rapid Alert System for immediate eradication of substandard and falsified product posing high level threats and effective recalls of defective therapeutic goods were deliberated upon in details. Finally, the communication mechanism for National Task Force was discussed in detail and agreed upon by the participants. 

World Patient Safety Day: DRAP takes part in global health campaign on Medication Safety; NPC holds a Webinar on” Medication without Harm” on 16th September, 2022

Asad Ullah Events, News & Updates

17th September has been declared as the World Patient Safety Day, to raise awareness about Global Patient Safety Challenges with a specific theme each year. One of the basic component of patient safety is putting an end to avoidable errors within healthcare settings.

WHO has identified “Medication Without Harm” as the theme for 2022 which is the third Global Patient Safety Challenge. This campaign is aimed to propose solutions to remove the obstacles prevalent today to ensure the safety of medication practices. The objective and voice “Medication Without Harm” aims to reduce avoidable medication-related severe harms by 50% globally in the next five years. Over the years, The challenge to ensure patient safety become more complex with new technology, treatments, and medicines being introduced in healthcare systems.

DRAP invites all healthcare professionals to work together to improve patient safety and ensure use of medications without harm

How to Join Our Webinar

The National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan has scheduled an online session on 16th of September, 2022. This session is the part of the our campaign on the World Patient Safety Day 2022 with a focus on theme “Medication Without Harm”.

Topic: Medication without Harm

Date and Time: Friday 16, September, 2022 at 10:00 AM to 11:00 AM

Join using Microsoft Team

Join a Microsoft Teams Meeting by ID | Microsoft Teams 
Meeting ID: 264 775 816 387 Passcode: J4tvFx

Click to Join

Join virtually using Microsoft team preferably 15 minutes before the start of session. Participants are advised to display their names and organization while joining the session. Please keep your mic and camera off after joining the session. If you wish to ask a question from the presenter, please click the icon to show raise hand, and turn your mic and camera on while asking a question.

-Sessions recordings and Training Materials will be available shortly after the session.

DRAP celebrated World Patient Safety Day 2022

The National Pharmacovigilance Centre, Division of Pharmacy Services, DRAP conducted an online session on the “Medication Without Harm” campaign of the World Patient Safety Day 2022. The target audience were healthcare professionals. The topics of Medication errors in context of healthcare institutes and medication safety & role of DRAP in the perspective of patient safety and pharmacovigilance were focused on in the session. Mst. Saharish Nazar, Agha Khan University Hospital (AKHU) and Mr. Abdul Mateen Focal Person National Pharmacovigilance Centre were the speakers in the session.


Dr. Noor Muhammad Shah, Head of National Pharmacovigilance Centre gave the message that patient safety is a mutual responsibility and presence of a reporting and learning system is essential. Muhammad Asad, Depuy Director Pharmacy Services conveyed the global scenario of harm caused due to medication and the importance of patient safety in provision of healthcare.

The session ended with the expectation of a positive impact on the working and output of pharmacovigilance in the country.