Home > Uncategorized

Uncategorized

DRAP Releases 2nd Edition of Guidelines for Good Clinical Practice (GCP) Inspections

Mughees Mudassir Uncategorized

The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce the release of the second edition of the “GUIDELINES FOR CONDUCT AND REPORTING OF GOOD CLINICAL PRACTICE INSPECTIONS“.

These guidelines provide a comprehensive framework for all stakeholders involved in clinical research related to therapeutic goods in Pakistan.

Key Features of the Updated Guidelines:

  • Enhanced Clarity: This second edition streamlines the guidance, making it easier for sponsors, investigators, research institutions, and laboratories to understand the procedures for GCP inspections.
  • Broader Applicability: The guidelines now explicitly cover Contract Research Organizations (CROs), BA/BE Study Centers, and Bio-Analytical Laboratories involved in clinical trials.
  • Improved Transparency: The revised document clearly outlines the roles and responsibilities of both clinical research participants and DRAP inspectors during the inspection process.
  • Risk based GCP Inspections

Benefits of Following these Guidelines:

  • Ensuring Patient Safety: Adherence to GCP principles is critical for safeguarding the well-being of participants in clinical trials.
  • Promoting Research Quality: Clear communication of inspection procedures fosters a transparent and high-quality research environment.
  • Facilitating Regulatory Compliance: Understanding inspection protocols allows research entities to prepare effectively and demonstrate compliance with DRAP regulations.

We encourage all parties involved in conducting clinical research in Pakistan to download and familiarize themselves with these updated guidelines.

Download the “GUIDELINES FOR CONDUCT AND REPORTING OF GOOD CLINICAL PRACTICE INSPECTIONS”

Recall Alert: Drug Product; Cetafend Infusion (Batch # 23RC55) by M/s Friends Pharma (Pvt.) Ltd, Lahore

Asad Ullah Uncategorized

Recall Alert

Download

DRAP Alert NoNo I/S/12-23-47
Action Date28th Dec, 2023
Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
· General Public
Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. KQ-11-23-000155 dated 12-12-2023 has declared the Cetafend Infusion Batch No. 23RC55 as of substandard quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Cetafend 1g/100mL Infusion
 
Reg.No 091872		ParacetamolBatch No. 23RC55
 
Mfg. Date: 10-2023
Exp. date: 10-2025		M/s. Friends Pharma (Pvt.) Ltd.
Ferozepur Road, Lahore
Risk Statement:Cetafend Infusion contains Paracetamol, a medicine used to treat mild to moderate pain. Paracetamol can also be used to treat fever (high temperature). Administration of products containing visible solid particles to patients through IV infusion may lead to complications, as well as an increased risk of venous thromboembolism. The age-profile of patients is important and young patients especially seem to be at risk.
Action Initiated-The manufacturer has been directed to immediately recall the defective 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 quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s).

-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 ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

-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 this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

-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.

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

    Asad Ullah Uncategorized
    Download

    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; Awahaem Tablets (Batch # 2781 by M/s. Usawa Pharmaceuticals, Rialpur.

    Asad Ullah Uncategorized

    Recall Alert

    DRAP Alert NoNoI/S/01-23-04
    Action Date23rd January 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 Awahaem Tablets
    Active Ingredient(s): Elemental Iron 100mg & Folic Acid 0.35mg
    Company: Ms. Usawa Pharmaceuticals (Pvt.) Ltd., Risalpur
    Batch No. 2781
    Manufacturing Date: 06-2022
    Expiry Date: 06-2024
    Problem / Issue CDL Karachi has declared the batch No. 2781 of Awahaem Tablets, manufactured by M/s. Usawa Pharmaceuticals (Pvt.) Ltd., Risalpur as substandard drug product.
    Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

    -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / 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.
      Awahem-Tab-Recall-AlertDownload

      National Pharmacovigilance Centre, DRAP holds one-day training session for Healthcare Professionals in collaboration with regional centre.

      Asad Ullah Events, Uncategorized
      National Pharmacovigilance Centre, DRAP holds one-day training session for Healthcare Professionals in collaboration with regional centre.


      National Pharmacovigilance Centre (NPC), Drug Regulatory Authority of Pakistan (DRAP) in collaboration with Islamabad Pharmacovigilance Centre and Shifa
      International Hospital, Islamabad conducted a one-day pharmacovigilance training session on 19th of May, 2022. Director and Deputy Director Pharmacy Services Division, Team Lead Vigilance and Focal Persons of National Pharmacovigilance Centre and Islamabad Pharmacovigilance Centre attended the training session.

      Pharmacovigilance focal persons of public and private sector hospitals of Islamabad were trained on ADRs reporting as per Pharmacovigilance Rules, 2022. Hands-on training on collecting and filling in ADRs reporting forms and subsequent causality assessment was provided to the participants. The training was concluded with the hope of arranging further such sessions in the future.

      Islamabad 19th May, 2022: One-day training session on pharmacovigilance activities for healthcare professional conducted by National Pharmacovigilance Centre, DRAP, Islamabad in collaboration with regional pharmacovigilance centre, Islamabad

      DRAP issues guidance on the submissions of Clinical Trials Applications

      Asad Ullah Clinical Trials, Publications, Regulatory Updates, Uncategorized

      The Drug Regulatory Authority of Pakistan (DRAP) regulates the conduct of clinical trials of therapeutic goods in Pakistan under the Bio-Study Rules, 2017. This document provides general guidance to the applicants in making new applications for clinical trials on therapeutic goods, or any subsequent submissions and regulatory requirements to be fulfilled. It also provides an outline on the procedure for submission, review, evaluation and approval of applications for the conduct of clinical trials.

      These guidelines will assist sponsors, researchers, investigators, clinical research organization (CRO), who intends to submit a new application for conduct of a clinical trials or its subsequent submissions under the regulatory scope of the Bio-Study Rules, 2017.

      These guidelines explains the procedures for filing applications of clinical trials and provides an insight on the steps to be followed by the applicants. As per DRAP Act, 2012 and Drug Act, 1976 it is required that all the therapeutic goods marketed in Pakistan must have a valid authorization / registration with the Drug Regulatory Authority of Pakistan (DRAP), and any clinical trials using such registered or unregistered products must receive written approval (i.e. license for Clinical Trial Site & Clinical Studies) from DRAP, under the Bio-Study Rules 2017 for that purpose.

      DRAP published the draft of this guidance document on its website on 8th April, 2022 inviting the comments of stakeholders on the draft. After through consultation and careful consideration, fist edition of the guidance document on the clinical trial applications is finalized. Nevertheless, anyone can still furnish his/her comments on the guidance documents using our comments submissions methods for consideration in the future editions of the document.

      Please click here to view the Guidance on Clinical Trials Applications

      National Pharmacovigilance Centre, DRAP issued draft guidelines on promoting Pharmacovigilance activities in Public Health Programs (PHPs).

      Asad Ullah Regulatory Updates, Uncategorized

      Drug Regulatory Authority of Pakistan (DRAP) aims at providing a holistic system of Pharmacovigilance in the country. Public Health Programs are key stakeholders involved in the reporting, assessment and risk communication of various un-wanted effects arising after the use of drugs, vaccines and other therapeutic goods. Reporting of Adverse Events associated with the use of therapeutic goods exclusively being used by PHPs is essential to a pharmacovigilance system.

      The key objectives of pharmacovigilance activities in public health programs are:-

      1. To improve public health and safety in relation to the use of therapeutic goods in PHPs;
      2. To detect problems related to the use of therapeutic goods and associated risk communication in a timely manner
      3. To encourage the safe, rational and more effective use of therapeutic goods.

      This guideline will assist the Public Health Programs (PHPs) for enhancement of pharmacovigilance activities, and provide a guidance on communication channels among PHPs and Pharmacovigilance Centres for collaborative working to synergize activities within the National Pharmacovigilance system of Pakistan.

      Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to npc∂dra.gov.pk, copying at aqsa.hashmi∂dra.gov.pk, or can post at mailing address, Director, Pharmacy Services, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

      Please click here to view draft guidance document GUIDELINES ON PHARMACOVIGILANCE FOR PUBLIC HEALTH PROGRAMMES

      DRAP issues guidelines on Good Pharmacovigilance Practices for Product Registration Holders

      Mughees Mudassir Uncategorized

      Registration holders are stakeholders of pharmacovigilance who have valid registration of therapeutic goods. There are also legal obligations on registration holders to monitor the safety of therapeutic goods. Therefore, there is a need that they should have basic knowledge and understanding of pharmacovigilance activities to fulfil their legal obligations. The purpose of this guidance document is to provide a basic framework for the implementation of the pharmacovigilance programme of Pakistan and to ensure that registration holders are better equipped to monitor the safety of therapeutic goods and to detect, assess, understand, prevent and investigate ADRs/ AE and AEFI reports.

      This guidelines intended to assist registration holders:

      a. To develop a pharmacovigilance system and monitor the safety of therapeutic goods registered in their name;
      b. Collect pharmacovigilance data, perform its assessment and accordingly submit to National Pharmacovigilance Centre (NPC), DRAP;
      c. Cooperate with NPC in the performance of pharmacovigilance inspection;
      d. Preparation and submission of periodic safety reports and risk management plan;
      e. Design and conduct post-authorization safety studies; and
      f. Detect, validate and assess signals and accordingly communicate to NPC and other stakeholders and considers options for risk minimization.

      Click Here to access the guidelines.