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Regulatory Updates

National Pharmacovigilance Cell (NPC), DRAP released draft Guidelines on National Pharmacovigilance System (Edition 02) seeking comments from stakeholders

Asad Ullah News & Updates, Pharmacovigilance

DRAP has established the National Pharmacovigilance Centre (NPC), under the Division of Pharmacy Services, DRAP, Islamabad, to monitor the safety of therapeutic goods across the country. NPC is working with National and International coordination for the development of a functional Pharmacovigilance system in the country. Since 2018, Pakistan is the Full member of the World Health Organization Programme for International Drug Monitoring (WHO-PIDM), Uppsala Monitoring Centre (UMC), Sweden.

The NPC has developed multi channel reporting system, including electronic and manual reporting forms supported with the guidelines that are available through the official website for stakeholders. With the promulgation of Pharmacovigilance Rules, 2022, it is now the legal obligation of all pharmacovigilance stakeholders to establish their system and report the pharmacovigilance data to NPC.

The 1st Edition of National Pharmacovigilance Guidelines were published in October, 2019. This is the draft for 2nd Edition of National Pharmacovigilance Guidelines, being revised in the light of recently enacted Pharmacovigilance Rules, 2022. This Guidance document is intended to assist all pharmacovigilance stakeholders i.e. Healthcare professionals, Marketing Authorization Holders, Healthcare providing institutes, Patients and caregivers, etc., in playing their roles and responsibilities in the national pharmacovigilance system. The WHO Pharmacovigilance indicators have been incorporated in the chapter 11 of the draft 2nd edition to harmonize the procedure performance evaluation with international standards.

These guidelines are uploaded on the official website of DRAP on 24th of August, 2022 for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to npc∂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.

Please click here to view the draft document National Pharmacovigilance Guidelines 2022

National Essential Medicine Lists

Asad Ullah Notifications, Pharmacovigilance, Publications , ,

Availability of essential medicines is one of the essential building blocks of healthcare system. Essential medicines are those which satisfy the primary healthcare need of the population. These are intended to be available within the context of functioning of health system at all times, in adequate amounts, in the appropriate dosage form with assured quality, and at a price that the individual and community can afford.

Careful selection of a limited range of essential medicines of high quality can provide better management towards judicious use of health resources.

National standard treatment guidelines navigate selection of essential medicine with the expectation to ensure their availability with reference to proper use of medicine within the healthcare system while reducing its cost.

National Essential Medicine List NEML is a critical document which provides and supports quality of health services across the country. The list is based on disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness and parameters adapted by W.H.O in its latest edition of Model List of Essential Medicines.

Health sector in general and Pharmaceutical sector in particular is expected to seriously consider adopting this list as a way forward to guide Provincial Governments in Medicine & Pharmaceutical sector policies, the determinants of medicines access and availability. The Provincial Governments can play a pivotal role to encourage procurement and supply chain management policies based on essential medicine concepts to promote rational use of scarce public resources. Drug Regulatory Authority is committed to make all efforts to improve patient care through availability of cost efficacious, safe & quality medicines availability in the country.

Current List

National Essential Medicine List-2025
English ( 47.8 MB – PDF)

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Previous Lists

National Essential Medicine List-2023
English ( 47.8 MB – PDF)

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National Essential Medicine List-2021
English ( 10.8 MB – PDF)

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National Essential Medicine List-2020
English ( 55 MB – PDF)

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National Essential Medicine List-2018
English ( 15 MB – PDF)

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National Essential Medicine List-2016
English ( 39 MB – PDF)

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Policy for Inspection of Manufacturing Site Abroad

Asad Ullah Drugs, News & Updates, Notifications, Regulatory Updates

Policy Board of the Drug Regulatory Authority of Pakistan (DRAP) has given policy guidelines for inspections of manufacturers keeping in view the suggestions/guidelines of WHO for reliance on other regulatory authorities. Accordingly, the revised “Policy for inspections of manufacturers abroad” as approved by the Policy Board under Section 11 (I) (a) of the DRAP Act, 2012, as under:-

Current-Policy-fo-inspectionDownload

DRAP notified National Pharmacovigilance Centre (NPC) under the Pharmacovigilance Rules, 2022

Asad Ullah Notifications, Pharmacovigilance, Press Releases

Drug Regulatory Authority of Pakistan (DRAP) , in pursuance to the enactment of Pharmacovigilance Rules, 2022 has notified the National Pharmacovigilance Centre, with the aim to further enhance the Pharmacovigilance activities includes collecting, analyzing, monitoring, and preventing adverse effects in the therapeutic goods.

DRAP also encourages all healthcare professionals to establish the practices of pharmacovigilance in the country as they have pivotal role in monitoring the safety and efficacy of therapeutic goods, particularly for newly-marketed product.

NPC-Notification-10.06.2022Download

The Authority, under Rule 3(1) read with Rule 3 (2) of the Pharmacovigilance Rules, 2022, notified the National Pharmacovigilance Centre under the Division of Pharmacy Services, DRAP.

The safe use of drugs, vaccines, medical devices and other therapeutic goods medicines is the most important criteria for DRAP to protect the public health and integrity of national healthcare system. Pharmacovigilance is the mechanisms to map and ensure the safety of therapeutic goods throughout their life span – from clinical trials to patient or consumer.

The importance of Pharmacovigilance is increased further in the current era due to arrival of novel of biopharmaceutical products and innovative technologies in healthcare practices.

National Pharmacovigilance Center (NPC) is working at DRAP and Pakistan is a full member of the WHO Programme for International Drug Monitoring.

Two Provincial Pharmacovigilance Centres in Punjab and Islamabad are also working in addition to a Centre of EPI (immunization programme), collecting ADR data and collaborating with the National Centre. National Pharmacovigilance Centre (NPC) has also established a Pharmacovigilance Risk Assessment Expert Committee (PRAEC).

NPC is Coordinating with other provinces/administrative territories, PHPs for establishment of their PV centers and also communicating with manufacture and importers of therapeutic goods for establishment of their pharmacovigilance system and reporting of ADRs to DRAP.

NPC has also published various documents and Guidelines for Stakeholders on pharmacovigilance activities, including :-

  1. Pakistan National Pharmacovigilance Guidelines
  2. Good Vigilance Practice Guidelines for Pharmaceutical Companies
  3. Pharmacovigilance Guidelines for Healthcare Professionals
  4. Pharmacovigilance Guidelines for Patients Pharmacovigilance
  5. Guidelines for Public Health Programmes.

Proposed amendments in the Rules : DRAP invites comments from stakeholders and public on the draft amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976;

Asad Ullah Drugs, Legislation, Licensing and Inspections, Regulatory Updates, SROs ,

The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976. The proposed amendments relates to the minimum area requirement for establishment of a pharmaceutical manufacturing units and adoption of Pharmaceutical Inspection Cooperation / Scheme (PIC/S) Guidelines for Good Manufacturing Practices (GMP), in order to further align more closely with the international standards and best practices, as practiced by many other regulatory authorities around the world.

The DRAP proposes to do so primarily by incorporating the provisos to enable manufactures and regulators to follow principles set by the Pharmaceutical Inspection Cooperation / Scheme (PIC/S) to maintain the quality standards at an acceptable level. PIC/s guidelines provide comprehensive guidance for both industry and regulators on various aspects of Good Manufacturing Practices.

DRAP has the mandate to issue guidelines and to monitor enforcement of licensing of manufacture of therapeutic goods and to implement internationally recognized standards under Section 7(c)(i) & (ix) of the DRAP Act, 2012. Control of environmental conditions for pharmaceutical industry is essential to manufacture quality products. and implementation of Good Manufacturing Practices (GMP) guidelines is critical to ensure the proper design, monitoring, and control of the manufacturing processes and facilities.

Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification in the official Gazette of Pakistan using prescribed format, via email to aamar.latif∂dra.gov.pk, or can be posted at mailing address, Deputy Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.

SRO 778 (I)/2022 dated 10th June, 2022

SRO-778-of-2022-PIC-GMPDownload

National Pharmacovigilance Centre, DRAP intends to seek comments of Stakeholders on “Draft Guidelines on High Alert Medication Management”

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 prepares and 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.

NPC, DRAP has recently published a revised list of High Alert Medication on the official website and is currently developing a Guidelines on High Alert Medication Management.

This document is intended for the guidance and support of hospitals and healthcare professionals (HCP) for safe prescribing, dispensing, administration and monitoring of high alert medication (HAM) and applies to all healthcare settings and healthcare professionals involved in 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 is uploaded on the official website of DRAP dated 16th June, 2022, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can be accessed on this link). Comments and 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 here to view the draft Guidelines on High Alert Medication Management (Edition 01)

Decisions of 47th meeting of Medical Device Board Meeting; Deficiency letter

Asad Ullah Medical Devices, Medical Devices Board

The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 47th meeting has deferred the 271 applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board, in the below attachment.

List-Deferred-Cases-of-MDB-47-Meeting

DRAP invites comments of stakeholders on the draft Guidelines on Good Distribution Practices for Pharmaceutical and Biological Products

Ijaz Mustafa Drugs, Publications, Regulatory Updates ,

Distribution of drug products includes all activities consisting of procuring, storage / holding, supplying, importing, and / or exporting of products. Such activities are carried out by the marketing authorization /registration holder including manufacturers/importers or their authorized distributors, which supply products to the pharmacies/licensed drug sale outlets and healthcare institutions which are entitled to dispense drug products.

Good Distribution Practice (GDP) is the set of standards of quality assurance for sourcing, handling, storage, and transportation of pharmaceutical and biological drug products under appropriate conditions, as required by the marketing authorization (MA) / registrant, or product specifications. To maintain the quality of pharmaceutical and biological products, every activity in the supply chain and distribution network should be carried out according to the principles of Good Distribution and Storage Practices.

These guidelines are drafted to provide appropriate systems and structures to assist manufacturers, distributors and wholesalers in fulfilling their responsibilities of planning and conducting various activities in the distribution and supply chain, which will be helpful in prevention of proliferation of unauthorized/unregistered, substandard and falsified products in the market.

This draft guideline is uploaded on the official website of DRAP dated 28th May, 2022, for seeking comments and suggestions from stakeholders on the draft document. 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 ajmal.sohail∂dra.gov.pk, copying at akbar.ali∂dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click to view the draft Guidelines-on-Good-Distribution-PracticesDownload

Stakeholder Comments are invited on draft guidance for Categorization of deficiencies in Good Manufacturing Practices (GMP)

Ijaz Mustafa Drugs ,

Drug Regulatory Authority of Pakistan (DRAP) aims at providing a comprehensive guidance to the inspectors for categorizing the GMP non-compliances found during inspections. This document is intended to inform stakeholders regarding the principles used to classify GMP deficiencies and provide examples of the classification of different types of deficiencies.

The key objectives of categorizing the GMP non-compliances during report writing are:-

The harmonization of the classification of GMP deficiencies to facilitate synchronized reporting of GMP deficiencies from inspections across the inspectorate. Harmonization will help ensure that there is a consistent view across the inspectorate of what constitutes a “Critical” deficiency and what constitutes a “Major” deficiency. Risk management principles will be applied to the categorization of these deficiencies dependent on the type of product manufactured or process.

This guidance document is also intended to:

  1. provide actions to be taken by inspectorates in response to the reporting of critical and major deficiencies;
  2. enhance communication, information sharing and scientific exchange to promote increased consistency and predictability in regulatory
  3. to provide a tool to support the risk-based classification of GMP deficiencies from inspections and to establish consistency amongst Inspectorates.

This guidance will enable Industry to be informed of the principles used to classify GMP deficiencies and also provide examples of the classification of
different types of deficiencies. Notwithstanding, this approach is not binding as the classification takes also into account the context of the finding and the quality history of the site. It does not remove the responsibility of the company in assessing the impact of he finding on the products already on the market and/or on their quality system.

Consistency of classification of GMP deficiencies will assist in the following:

  1. Improve consistency in reporting and facilitate communication between inspectors;
  2. Harmonize inspectorate response and management of deficiencies classified as “Critical”, “Major” and “Other”;
  3. Provide transparency in how the deficiencies are classified; and
  4. Simplify deficiency trend analysis based on harm

This draft guideline is uploaded on the official website of DRAP dated 28th May, 2022, for seeking comments and suggestions from stakeholders on the draft document. 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 ajmal.sohail∂dra.gov.pk, copying at hasan.afzaal∂dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click to view the Draft Guidance on categorization of deficiencies in GMPDownload