News & Updates
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 |
Change in Manufacturing Unit of M/s Sois Life Sciences to Site at G-77. S.I.T.E. Super Highway, Phase-II, Karachi.
The Enlistment Evaluation Committee (EEC) in 120th meeting has considered the request of M/s Sois Life Sciences for change in manufacturing facility for their products from A-84, SITE, Super Highway, Phase-I, Karachi to their manufacturing site situated at G-77, S.I.T.E, Super Highway, Phase-II, Karachi. The EEC acceded the request of the firm and revoked the Enlistment Certificate No 01304.
Henceforth, all the product of M/s Sios Sois Life Sciences will be manufactured G-77, S.I.T.E, Super Highway, Phase-II, Karachi viz-a-viz Enlistment No. 0090. Therefore, manufacturing of Alternative medicines and health products by M/s Sois Life Sciences at A-84, S.I.T.E, Super Highway, Phase-I is prohibited and punishable offence under Rule 11 of the SRO 412 (I) /2014 read with Schedule II and III of the DRAP Act, 2012. Accordingly Notifications have been issued for strict compliance.
Implementation of Post Registration Variation Guidelines for Pharmaceutical and Biological Products (2nd Edition)
The Drug Regulatory Authority of Pakistan (DRAP) has recently released the 2nd Edition of the Post Registration Variation Guidelines for pharmaceutical and biological drug products. These guidelines provide essential information for submitting post-registration variation applications by registration holders and marketing authorization holders of drug products. The guidelines distinguish between minor variations (MiV-N, MiV-PA) and major variations (MaV), with specific timelines for each type. Applicants are required to adhere to the prescribed “Form” and documentation requirements when submitting variation applications.
Stakeholder Nominations are invited to a Webinar on GMP for Blood Establishment
World Health Organization (WHO) has developed a Guidance on Good Manufacturing Practice (GMP) for Blood Establishment to ensure the safety and quality of blood products with the aim to strengthen the technical capacity of National Regulatory Authorities (NRAs) for implementing the appropriate control of blood products. This GMP webinar will explain GMP principles and concepts comprehensively.
Drug Regulatory Authority of Pakistan (DRAP) invites healthcare professionals and stakeholders working in the blood establishments to attend/participate in the World Health Organization (WHO) webinar on “Good Manufacturing Practice (GMP) for Blood Establishment from 7 to 10 May 2024.
Combating Substandard and Falsified Products : Public Alert Reporting
Islamabad, 4th April, 2024 — The Drug Regulatory Authority of Pakistan (DRAP) is aiming for effective communication and public awareness on combating Substandard and Falsified (SF) products to protect public health; hence the frequency of public alerts is likely to increase, and media communication of key messages represents an important mediator of the behaviour of individuals in response to public health countermeasures. Since culpability is commonly used as a tool to influence public behaviour, it is important to keep the public informed while avoiding panic due to misinformation/disinformation,
In a recent event, DRAP issued an alert No I/S/03-24-15 regarding the presence of falsified Risek 40mg injections in the market. This alert was intended to caution healthcare providers and the public about the presence of counterfeit products in the market and to procure the product from authorized sources only. Unfortunately, some misinterpretations of the alert have led to widespread misinformation.
DRAP is committed to ensuring the safety and well-being of the public and calls for responsible reporting. We are working diligently to remove the falsified products from the market and to hold those responsible, accountable.
Switching Over to Pakistan Single Window (PSW) for Drug Import License and Import Release of Donations Medicines
The Drug Regulatory Authority of Pakistan has switched over submission, processing and release order of Drug Import License and Import release of donation medicines on Pakistan Single Window (PSW).
Drug Import License (DIL)
All Drug Manufacturing License (DML) holder companies are enabled o submit applications for all type of Drug Import License form March 05, 2024 through PSW System..
Import of Donations
All registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs are required to submit applications for import clearance on through PSW System from February 29, 2024