National Essential Medicine Lists

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

The current version, updated in December 2021 is based on the 22nd WHO Model List of Essential Medicines List (MLEM).

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

Previous Lists

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

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

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

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

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.

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

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.

DRAP issues guidance on the submissions of Clinical Trials Applications

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