News & Updates
Webinar on Building Effective Medicine Pricing Policies for Low- and Middle-Income Countries
The Drug Regulatory Authority of Pakistan held an insightful discussion on “Building Effective Medicine Pricing Policies for Low and Middle-Income Countries on Tuesday July 23, 2024 at 10:00 AM at DRAP HQ, Islamabad. The session was led by Prof. Zaheer-Ud-Din Babar, University of Huddersfield and Editor-in-Chief of the Journal of Pharmaceutical Policy and Practice. Senior management of the DRAP attended the session at DRAP HQ, Islamabad, while more than 100 colleagues from industry and academia participated in the session virtually.
The discussion among participants centered on evidence-based challenges and potential solutions for medicinal pricing policies, tailored to the specific needs of low and middle-income countries. It included an analysis of five distinct pharmaceutical pricing strategies and the primary enablers for developing effective policies.
In case you missed the live session, the webinar recording is available at the following link.
Bioequivalence and Bioavailability of Drug Products
The Drug Regulatory Authority of Pakistan (DRAP) is committed to ensure that all pharmaceutical drug products shall conform to acceptable standards of safety, efficacy and quality. The submission of bioequivalence studies is requirement of Form-5F (Common Technical Document) notified vide SRO 713(1)/2018 dated 08.06.2018.
The Registration Board, in its 338th meeting on July 4, 2024, resolved that the regulatory approval process for the registration of generic drugs in light of the guidelines of international regulatory agencies will include the implementation of Bio-equivalence studies in adherence to WHO guidelines. The decision of the Registration Board is hereby communicated for implementation.
DRAP Finalized Guidelines on Standards for Establishment of Hospital Pharmacies
Guidelines on standard for Establishment of Hospital Pharmacies are intended to serve as a basic guide for the provision of pharmacy services in the hospitals within the country. These guidelines outline a set of services that are expected from hospital pharmacy departments and are aimed at ensuring consistent, high-quality pharmacy services across all hospitals, ultimately benefiting patients and the healthcare system as a whole.
The guidelines cover four key areas:
- Hospital Pharmacy Operations which include aspects like organizational structure, staffing, resources, policies, and procedures for managing medications from procurement and storage to dispensing and monitoring.
- Medicine Use Management where the focus is on optimizing medication use within the hospital. This involves procedures for medication reconciliation, identifying potential issues, and implementing strategies to improve medication effectiveness and avoid medication-related harm.
- Quality Improvement with the believe in continuous improvement! These guidelines outline practices for assessing the effectiveness of hospital pharmacy services, identifying areas for improvement, and implementing corrective actions.
- Human Resources Development for ensuring a competent and skilled pharmacy workforce is crucial. The guidelines address training and development programs for all pharmacy personnel, from pharmacists to technicians.
These guidelines were uploaded on DRAP website as well as shared with the stakeholder as draft document for their inputs and comments in January 2024. After careful consideration of comments and deliberation through multiple virtual meetings, these guidelines have been finalized and being circulated as a guidance document providing minimum standards for establishment and functioning of hospital pharmacies in the country.
Series of Training on National Pharmacovigilance System for Registration holders (Manufacturers and Importers)
The Drug Regulatory Authority of Pakistan (DRAP) has established the National Pharmacovigilance Centre (NPC) under the Division of Pharmacy Services. This initiative is aimed at ensuring the safety of therapeutic goods. With its endeavour, Pakistan became the 134th full member of the Programme for International Drug Monitoring (WHO-PIDM), Uppsala Monitoring Centre in 2018.
Subsequently, the DRAP notified Pharmacovigilance Rules, 2022 which outline the roles and responsibilities of pharmacovigilance stakeholders, including registration holders of therapeutic goods. The DRAP has also developed Guidelines on Good Pharmacovigilance practices for registration holders that outline step-by-step guidelines on the establishment of pharmacovigilance systems in pharmaceutical companies. The NPC has dedicated tools in place for the collection of adverse drug reaction reports (ADRs) from pharmaceutical companies (registration holders) such as E2B XML submission through dedicated email, and hard copy submissions via mailing address
Despite the above efforts of DRAP, very few pharmaceutical companies have established their pharmacovigilance centres and nominated their qualified persons for pharmacovigilance. Implementing pharmacovigilance rules, 2022 and establishing an effective pharmacovigilance system by all stakeholders, including registration holders is a prerequisite for ensuring the safety of medicines in Pakistan. This will reduce the risks associated with medications, thereby ensuring patient safety. This is why DRAP feels that there is a need to enhance the capacity of registration holders in respect to pharmacovigilance.
In this regard, the NPC, Division of Pharmacy Services, DRAP intends to conduct training of pharmaceutical companies (registration holders) on pharmacovigilance rules, guidelines and pharmacovigilance systems including collection and reporting of pharmacovigilance data. Three virtual training session will be conducted in the month of July 2024.
Tender notice for supply of Fourier Transform Infrared Spectrophotometer (FTIR) to CDL Karachi)
Introducing Centralized Case Management System for Enhanced Efficiency and Transparency
The Drug Regulatory Authority of Pakistan (DRAP) has introduced a centralized case management system, aimed at boosting operational efficiency and ease of doing business processes for the therapeutic goods industry. This system is designed to monitor the processing of applications and to enable applicants to track their regulatory submissions and furnish additional details as required, marking as a significant step towards enhancing transparency and efficiency.
All licensed / applicant of therapeutic goods manufacturers/importers/exporters/ clinical trial sites/ CROs etc can access this system on eAPP module (www.eapp.dra.gov.pk) of DRAP through their existing secured account credentials, effective from 29th May, 2024. This module ensures that submissions are forwarded to the Director of the concerned Divisions with visibility for applicants to track their cases and receive timely responses, under monitoring by the DRAP’s higher management.
We are hopeful that implementation of this new system will significantly improve the visibility of application processing and streamline regulatory operations.
Report on Availability Status and Supply Disruption of Eye Drops
The Drug Regulatory Authority of Pakistan (DRAP) has received information that certain brands of eye drops are short in supply in the market. The DRAP’s committee has conducted a quick survey of the market and found certain alternative brands available in the market. The main reason behind their short supply is the change of ownership globally from Allergan to AbbVie.
In this regard, Physicians are advised to consider prescribing the available alternative brands to their patients in light of the shortage. Patients should be informed about this during their consultations. Similarly, pharmacists should also communicate the availability of alternative brands to patients or caregivers.
Briefly, the availability status of eye drops reported short along with their alternative brands is presented in the table below:
| Sr. No. | Name of Drug Products | Manufacturer/ importer | Status | Reason / Stock position | Alternate brand available |
| 1 | Combigan Eye drops (Brimonidine and Timolol) | M/s Barrett Hodgson | Short supply | Global merger/ acquisition (Change of ownership from Allergan to AbbVie) | Brytim Eye Drops (Remington) Imosol eye Drops (Schazoo) |
| 2 | Lumigan Eye drops (Bimatoprost) | M/s Barrett Hodgson | Short supply | Global merger/ acquisition (Change of ownership from Allergan to AbbVie) | Allure Eye drops (Sante) |
| 3 | Alphagan Eye drops (Brimonidine tartrate) | M/s Barrett Hodgson | Short supply | Global merger/ acquisition (Change of ownership from Allergan to AbbVie) | Brimodine Eye drops (Sante) Brimod eye drops (Remington) |
| 4 | Cosopt eye drops (Dorzolamide and Timolol) | M/s OBS Pakistan | Short Supply | Stock of 30,000 packs is in transit. | Co-Dorzol eye drops (Sante) Co-Dorz eye drops (Ethical) |
Expressions of Interest (EOI) for pool of expert members of central licensing board of DRAP
Schedule of Meetings of Clinical Studies Committee (CSC) for the Year 2024
The Clinical Studies Committee (CSC) of Drug Regulatory Authority of Pakistan (DRAP) is mandated under Bio Study Rules 2017 for the regulatory oversight of clinical trials and clinical studies related to therapeutic goods in the country. The CSC reviews and approves clinical study protocols, ensuring they adhere to ethical and scientific standards. It also monitors ongoing clinical trials to assess participant safety and efficacy, makes informed decisions regarding study design, and collaborates with researchers, sponsors, and other stakeholders to ensure quality clinical research and safety of the participants.
The Committee has decided that the CSC meetings will be convened after every 45 days and an annual CSC meeting schedule for 2024 (tentative) has been issued with the aims to enhance transparency, efficiency, and collaboration.
| S. No. | CSC Meeting | Proposed Dates |
| 01 | 49th CSC Meeting | 2nd week of May, 2024 |
| 02 | 50th CSC Meeting | 4th week of June, 2024 |
| 03 | 51st CSC Meeting | 2nd week of August, 2024 |
| 04 | 52nd CSC Meeting | 4th week of September, 2024 |
| 05 | 53rd CSC Meeting | 2nd week of November 2024 |
| 06 | 54th CSC Meeting | 4th week of December, 2024 |