Guidelines on Standards for Establishment of Hospital Pharmacies is now open for comments.

Drug Regulatory Authority of Pakistan is seeking feedback on proposed guidelines for hospital pharmacies. These standards aim to ensure consistent, high-quality pharmacy services across all hospitals, ultimately benefiting patients and the healthcare system as a whole.

The guidelines cover four key areas:

  1. 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.
  2. 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.
  3. 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.
  4. 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.

DRAP invites you to review the proposed guidelines and share your thoughts and suggestions. Your input will be invaluable in shaping the final document and ensuring it reflects the needs and expectations of patients, healthcare professionals, and the community.

These guidelines were uploaded on the official website of DRAP on 12th of January, 2024 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 dir.psdra.gov.pk, copying aqsa.hashmidra.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.

DRAP’s Pharmacovigilance Newsletter (December, 2023 ; Issue-II)

The Pharmacovigilance Newsletter is a quarterly publication that aims to inform and educate the healthcare professionals and the public about the importance of pharmacovigilance and adverse drug reaction reporting. It also showcases the activities of the National Pharmacovigilance Centre (NPC) and initiatives taken by the NPC for monitoring and evaluating the safety of medicines in Pakistan.

We are pleased to announce that the second issue of the Pharmacovigilance Newsletter (Dec-2023) is now available for download from our website. This issue covers the latest updates on the safety of medicinal products and regulatory actions taken by the Drug Regulatory Authority of Pakistan (DRAP) and other international authorities.

We hope that you will find the newsletter informative and useful. We welcome your feedback and suggestions for improvement. You can contact us at npcdrap.gov.pk or call us at +92-51-9255980. Thank you for your interest and support in pharmacovigilance.

Together, we can ensure the safe and effective use of medicines in Pakistan.

DRAP Participating in International Med Safety Week 2023 Social Media Campaign

From 6 to 12 November, Drug Regulatory Authority of Pakistan (DRAP) will take part in the global #MedSafetyWeek campaign, a collaboration involving more than 80 medicines regulatory agencies and several non-governmental organizations, to raise awareness about the importance of reporting side effects of medicines. With the theme ‘Who can report?’, this year’s campaign will focus on the key role of every patient, doctor, nurse, and pharmacist who reports a side effect and contributes to using medicines safely.

DRAP seek your support to enhance reporting of adverse drug reactions (ADRs) to ensure medicines on the market are acceptably safe.

Reports about side effects can be submitted easily through Med Safety App, DRAP med Vigilance e-reporting system or yellow reporting form.

For detail on how to report visit the link.

#MedSafetyWeek2023

Play your part in medicines safety. Whether you’re a patient, doctor, nurse, or pharmacist, you can help make medicines safer by reporting side effects to National Pharmacovigilance Centre, DRAP.

Through the #MedSafetyWeek campaign more than 80 countries will work together to improve the safety of medicines globally

All medicines agencies operate systems to detect and analyse side effects of medicines. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Constantly collecting and monitoring information from the reports received helps identify risks associated with medicines and take action to minimise harm.

#MedSafetyWeek is an international campaign of Uppsala Monitoring Centre (UMC).

The campaign is supported by WHO and by members of the International Coalition of Medicines Regulatory Authorities (ICMRA)

DRAP emphasizes the importance of reporting side effects through Med Safety App, DRAP med Vigilance e-reporting system or yellow reporting form. All reports made to National Pharmacovigilance Centre (NPC) DRAP will be thoroughly assessed and examined to determine the right steps to be taken to protect the population from harm. Since 2018, NPC DRAP has received and processed over 30,000 reports in which patients, carers, and healthcare professionals have played a key role

“Every report is important in building more knowledge and understanding of the benefits and risks of medicines in clinical use and allows action to be taken to minimise risks.

“Reporting suspected side effects to the NPC DRAP helps to make medicines safer for patients all around the world. In some cases, it can result in better prescribing advice, which can improve patient outcomes.

“If you, or a patient you are supporting, experience a side effect with a medicine, make sure to report it to us promptly.”

Dr.Obaidullah,

National Pharmacovigilance Centre, DRAP, Pakistan

DRAP invites Comments on Draft Guideline for Storage and Destruction of Substandard-Falsified (SF )and recalled Therapeutic Goods

The Drug Regulatory Authority of Pakistan (DRAP) has drafted a guideline on the storage and destruction of recalled therapeutic goods, which are medicines, medical devices, and health products that do not meet the quality standards or are deliberately misrepresented. The guideline aims to provide a framework for the safe and effective management of such goods, from their identification and reporting to their disposal and documentation.

The draft guideline covers the following aspects:

  • The roles and responsibilities of different stakeholders, such as manufacturers, importers, distributors, health care providers, and regulators, in handling substandard and falsified as well as recalled therapeutic goods.
  • The criteria for selecting suitable storage facilities and methods for defective therapeutic goods.
  • The methods for destroying in an environmentally sound manner.
  • The records and reports that need to be maintained and submitted.

The draft guideline is available on the DRAP website on 27th October, 2023 for public consultation. DRAP invites comments and feedback from all stakeholders, including the pharmaceutical industry, health professionals, civil society organizations, and the general public. 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 ajmal.sohaildra.gov.pk, copying at sanaullah.babardra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP appreciates the cooperation and participation of all stakeholders in ensuring the quality, safety, and efficacy of therapeutic goods in Pakistan.

DRAP Added New eService for Online Data Submission for Registration of Pharmaceutical and Biological Product

The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce the addition of a new e-service for online regulatory data submission registration/marketing authorization of human drugs for local manufacturing, import and export. The Licensing Operations of all [pharmaceutical and biological manufacturers are already enabled through the same plateform. This e-service is part of the transformation strategy of the Drug Regulatory Authority of Pakistan which aim 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 documents:

  • Data Submission Format for Licensing Operation of Pharmaceutical Manufacturers
  • Data Submission Format for Registration of Human Drugs
  • Data Submission Format for Renewal of Registration of Human Drugs
  • Data Submission Format for Variation in Registration of Human Drugs

The new e-service allows applicants to submit their data electronically through the eAPP portal, which is accessible 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 and will beWe welcome your feedback and suggestions on how to improve our services. Please contact us at infodra.gov.pk or +92 51 9260 500 for any queries or assistance. Thank you for your cooperation and support.

You can access the new e-service by clicking on this link:

National Hazardous Waste Management Policy 2022

The National Hazardous Waste Management Policy, 2022 of Pakistan is a set of guidelines for the environmentally sound management of solid and hazardous waste in the country. The Ministry of Climate Change has formulated this comprehensive national level policy through consultative process with relevant stakeholders. This Policy is aimed at acting as an umbrella document to address the issue of hazardous waste.

Pharmaceutical Industry being a potential source of generating hazardous material as byproduct of its manufacturing, research and development processes. These involve handling of various chemical compounds which may be toxic, reactive, flammable or otherwise hazardous to human health and environment Therefore, proper management of hazardous waste in pharmaceutical industry is crucial to protect human health and environment.

The Drug Regulatory Authority of Pakistan (DRAP) in 167th meeting directed to upload the National Hazardous Waste Management Policy 2022 on its website for the information and awareness of pharmaceutical industry and other stakeholders.

National Control Laboratories for Biologicals, DRAP issued Guidelines for Lot Release of Biological Products

The regulation of lot release is an integral regulatory control to ensure the quality and safety of biological products. Its purpose is to verify that each batch/lot of the product meets the stipulated standards of manufacturing and quality control. The National Control Laboratory for Biologicals (NCLB), Islamabad assumes the responsibility of overseeing lot release function through reviewing the manufacturer’s protocol, analytical methods and summary protocol, and also conduct analytical testing if necessary. This is aimed at assuring that every product batch/lot that enters the market adheres to the approved specifications at the time of registration, including any post-registration modifications or variations. The primary objective is to safeguard the public from substandard product batches/lot.

The National Control Laboratories for Biologicals, DRAP has published guideline on the procedural requirement for lot release of biological products. This guidance document was drafted and uploaded in May 2023 seeking comments from stakeholders. It provides an overview of the lot release process how the procedure is established and what products are covered under the lot release system.

DRAP finalized the 2nd Edition of Guidelines on Post-Registration Variation of Drug Products

DRAP has finalized the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. Registration / Marketing Authorization holders are responsible for the safety, efficacy, and quality of drug products that are placed on the market throughout their approved life cycle.

This guidelines are intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.

These Guidelines will assist both Regulators and Industry on the regulation of variation / changes to the original registrations / Market Authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required. Data requirements are listed out to evaluate the impact of the proposed / intended change on the quality, safety and efficacy of the locally manufactured / imported finished pharmaceutical and biological drug products intended for human and veterinary use.

These guidelines are intended to provide supportive information for submission of post registration variation application by the registrations / marketing authorization holders of the finished drug products to implement a change. The draft guidelines were uploaded on the website in July 2023 seeking comments of stakeholders on the contents of document.

The Guidelines have been finalized keeping in view the comments and suggestions of the Stakeholders. Please navigate to the Publications on the DRAP website for latest guidelines by DRAP.

116th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

The 116th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 23rd May, 2023. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.