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Series of Training on National Pharmacovigilance System for Registration holders (Manufacturers and Importers)

Asad Ullah General, Pharmacovigilance

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.

Introducing Centralized Case Management System for Enhanced Efficiency and Transparency

Asad Ullah General, Notifications, Press Releases

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.

Stakeholders-Task-ManagementDownload

Report on Availability Status and Supply Disruption of Eye Drops

Asad Ullah Drugs, General

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 ProductsManufacturer/ importerStatusReason / Stock positionAlternate brand available
 1Combigan Eye drops (Brimonidine and Timolol)  M/s Barrett HodgsonShort supplyGlobal merger/ acquisition (Change of ownership from Allergan to AbbVie)Brytim Eye Drops (Remington)
Imosol eye Drops (Schazoo)
 2Lumigan Eye drops (Bimatoprost)M/s Barrett HodgsonShort supplyGlobal merger/ acquisition (Change of ownership from Allergan to AbbVie)Allure Eye drops (Sante)
 3Alphagan Eye drops (Brimonidine tartrate)M/s Barrett HodgsonShort supplyGlobal merger/ acquisition (Change of ownership from Allergan to AbbVie)Brimodine Eye drops (Sante)
Brimod eye drops (Remington)
 4Cosopt eye drops (Dorzolamide and Timolol)M/s OBS PakistanShort SupplyStock of 30,000 packs is in transit.Co-Dorzol eye drops (Sante)
Co-Dorz eye drops (Ethical)

Change in Manufacturing Unit of M/s Sois Life Sciences to Site at G-77. S.I.T.E. Super Highway, Phase-II, Karachi.

Ijaz Mustafa Alternative Medicines, General

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.

Shifting-of-Sois-From-A-84-to-G-77-Karachi-0090Download

Revocation-of-Form-6-01304-of-Ms-Sois-KarachiDownload

Implementation of Post Registration Variation Guidelines for Pharmaceutical and Biological Products (2nd Edition)

Ijaz Mustafa Drugs, General

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.

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Guidelines on Risk Based Sampling and Testing of Drugs; Comments invited on draft Document

Asad Ullah Drugs, General ,

At the Drug Regulatory Authority of Pakistan (DRAP), our commitment to public health and safety drives our actions. We recognize that ensuring the quality and efficacy of pharmaceutical products is paramount. To achieve this, we emphasize risk-based sampling and testing strategies for assuring Safety and Quality of therapeutic goods to safeguard public health.

These Guidelines reflect a structured approach on regulatory oversight by allocating resources efficiently by prioritizing sampling collection, testing, and surveillance based on risk levels. This ensures that critical aspects of drug quality receive the attention at first and enable focusing regulatory efforts to high-risk areas. The draft guidelines are prepared based on the recommendation of ICH Q9 (Quality Risk Management), WHO working document QAS/15.630, and USP-PQM guidance document for implementing risk-based post-marketing quality surveillance in low and middle-income countries.

DRAP invites all interested parties and relevant stakeholders to provide their comments and inputs on the draft guideline. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to mehwish.tanveer∂dra.gov.pk with a copy to mahvash.ansari∂dra.gov.pk or can be posted at the following mailing address: Assistant Director (QC-II), Quality Assurance & Laboratory Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP appreciates your participation and contribution to this consultation process.

GUIDELINES ON RISK-BASED SAMPLING & TESTING OF DRUGSDownload

Important Notice to INGOs, NGOs, Hospitals and Government Programs/Departments Importers of Donated Drugs in Pakistan

Asad Ullah Drugs, General

The Drug Regulatory Authority of Pakistan (DRAP) and the Pakistan Single Window (PSW) have implemented an automated clearance system for the importation of donated drugs in Pakistan. This system aims to optimize and expedite the efficiency of the pharmaceutical supply chain in Pakistan and ensure a seamless and transparent delivery of donated drugs.

PSW Subscription Required for Donated Drugs Importation in Pakistan

To participate in this system, all registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs importation need to acquire their PSW Subscription promptly.

The PSW Subscription is a pivotal step in ensuring a smooth and sustainable pharmaceutical supply chain in Pakistan. Your subscription significantly contributes to the optimization of drug distribution, allowing us to collectively make a more substantial impact on public health.

How to Subscribe in 6 Easy Steps:

  • Visit the PSW website to access detailed instructions, user manuals, and demo videos.
  • Follow the straightforward subscription process and complete your subscription efficiently.
  • If you have any questions or require assistance during the subscription process, contact the PSW Support team at 021-111-111-779 or reach out via email at support∂psw.gov.pk.
DRAP-PSW-Online-module-for-donation-medicineDownload

DRAP added New features in eAPP system enabling Online Submission for all types of Registration Applications of Drug Products

Ijaz Mustafa Drugs, General

The Drug Regulatory Authority of Pakistan (DRAP) added a new e-service for online regulatory data submission for registration/marketing authorization of human drugs for local manufacturing, import and export. This e-service complements the existing one for licensing operations of all pharmaceutical and biological manufacturers, which are both accessible through the same platform. This e-service is part of the transformation strategy of the Drug Regulatory Authority of Pakistan, which aims to ensure the quality, safety and efficacy of therapeutic goods in Pakistan.

The e-service requires applicants to submit their data in a standardized format, as specified in the following type of submission:

  • Registration of Drugs on Form-5F for human Use.
  • Registration of Drugs on Form-5 & Form 5A for Veterinary Use.
  • Application for Post Registration Variations.
  • Renewal for Registration of Drugs

The new e-service allows applicants to submit their data electronically through the eAPP portal, which can be accessed after registering an account with DRAP. The e-service offers several benefits, such as:

  • Faster and easier data submission and processing
  • Reduced paper work and redundancy
  • Increased transparency and visibility

This new e-service will facilitate the licensing and registration process and improve the regulatory system in Pakistan. DRAP will reach out to applicants in assisting application submission on this new eService.

We welcome your feedback and suggestions on how to improve our services. Please contact us at info∂dra.gov.pk or +92 51 9260 500 for any queries or assistance.

We hope that these new features will further enhance the efficiency and convenience of our e-service and facilitate the development and availability of quality therapeutic goods in Pakistan.

E-APP-Circular-DRAPDownload