Bob Tribe, TGAs former GMP Chief, assists DRAP for Strengthening of Inspection System towards harmonized PIC/s GMP Standards

Bob Tribe, TGAs former GMP Chief, assists DRAP for Strengthening of Inspection System towards harmonized PIC/s GMP Standards

DRAP aims at harmonization of Inspection system and procedures in the field of Good Manufacturing Practices (GMP) for drugs, and quality system for inspectorate, comparable with the best international regulatory practices. In this regard, Mr. Robert Wayne Tribe, TGAs former GMP Chief is providing Consultation to DRAP for progress toward PIC/s membership.

Mr. Bob served as Chief GMP at the Australian TGA for 23 years, has a hand in creating many of the GMP requirements. He is regarded as true GMP expert and consults to many GMP regulators around the world, assisting them reach the PIC/S level of regulatory control. Bob’s also served as Deputy Chairman of the PIC/S during 1998-1999, followed by a tenure as Chairman of PIC/S from 2000-2001. During his recent visit in Pakistan, he conducted observed GMP Audit and various consultative sessions with the regulators, Inspectors, industry and senior management of DRAP to discuss the current level of GMP Inspection System and is advising on gap assessment of inspectorate system to be harmonized with the PIC/s GMP Standards. A training session was also organized for DRAP’s staff on PIC/s background information for the Applicant Authorities, PIC/s GMP requirements and inspection approach.

CEO, DRAP highly appreciated the efforts of Mr. Bob for extending his services to DRAP to further strengthening and harmonization of inspection system of Pakistan at par with the PIC/s Standards. DRAP is fully committed to undertake all measures to ensure consistent supply of standards quality therapeutic goods for the people of Pakistan.

An interactive Session of Academia and Regulators on Healthcare Research and Collaborative Role

Am interactive session on healthcare research, ethical practices and collaborative role of academia and regulators was arranged at DRAP HQ, Islamabad on 26th July, 2022. A renown academician, Prof.Dr. Zaheer ud din Babar, Professor in Medicines and Healthcare, Department of Pharmacy, School of Applied Sciences, Director, Pharmaceutical Policy and Practice Research Centre, University of Huddersfield, presented his expert views on the topic and led various discussions with regulators.

ISPE Singapore Conference & Exhibition 2022, 17-19 August, 2022 (Free Registration for Inspectors and Pharma Manufacturers from Pakistan)

The ISPE Annual Conference & Exhibition, 2022 for Pharmaceutical and biomanufacturing professionals is happening from 17-19 August, 2022 at Suntec, Singapore. This conference is aimed at highlighting global and regional best practices in process, technology and innovations. International and Asian manufacturers, regulatory agencies and subject matter experts share knowledge from manufacturing facility design to finished product.

The exhibition is known as showcasing latest technologies and services, workshops and discussion sessions. This year, participants can join the conference both in-person or virtually.

Free Registration for Inspectors, Pharma and Biomanufacturers form Pakistan

The organizers of ISPE Conference and Exhibition, 2022 have offered free registration for inspectors and all industry people from Pakistan who can get register for free to attend the ISPE Singapore conference in august, either online or in person.

Interested applicants are required to fill out the google form provided on the this link or by open below link in the browser:- https://docs.google.com/forms/d/e/1FAIpQLSdoBS_9feTiQZG_921XB1t1cZTn2uDAUj7lfX5C44uFzRIDrQ/viewform?usp=sf_link.
Please type in ‘ISPE’ in the first question field. The organizers will help them to issue the complimentary passes.

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 October 2023 is based on the 23rd WHO Model List of Essential Medicines List (MLEM).

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

Previous Lists

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

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)

National Pharmacovigilance Center Convened one-day Training Session for Clinical / Hospital Pharmacist and Pharmacovigilance Officer at Rawalpindi Medical University

National Pharmacovigilance Centre (NPC), Drug Regulatory Authority of Pakistan (DRAP) in collaboration with Holy Family Hospital, Rawalpindi Medical University conducted a one-day pharmacovigilance training session on 20th July, 2022 at Rawalpendi Medical University for Clinical Pharmacy and Pharmacovigilance Officers and Hospital Pharmacists of the public sector hospitals of the Rawalpindi Division.

Dr Noor Muhammad Shah, Director Division of Pharmacy Services (Head of National Pharmacovigelance Centre), Mr. Abdul Mateen, Assistant Director Pharmacy Services (Focal Person National Pharmacovigilance Centre), Mst. Aqsa Hashmi, Assistant Director Pharmacy Services and Mst. Nazima Asghar, Clinical Pharmacy and Pharmacovigilance Officer, Holy Family Hospital gave detailed presentations in the subject matter.

Medical Superintendent and Drugs Controller of Holy Family Hospital and Professor/HOD of Pharmacology Department along with her team from Rawalpindi Medical University also joined the session. Participants from Holy Family Hospital, Rawalpindi Institute of Cardiology, Benazir Buttto Hospital, Rawalpindi Institute of Urology and Transplant and Tehsil Headquarters hospitals of Murree, Taxila, Gujar Khan, Kallar Syedan, Kotli Sattian were trained by the above team of trainers from DRAP and Holy Family Hospital on different aspects of pharmacovigilance such as the establishment of pharmacovigilance centre, collection of data and subsequent reporting to the provincial pharmacovigilance centre of the Punjab. The training was concluded by the Head of the National Pharmacovigilance Center by highlighting the imminent points of the presentations with the hope that the session will bring significant improvement for establishment of Pharmacovigilance Centers and reporting of ADRs accordingly.

Draft amendments in rules framed under Drug Act 1976 (for comments within 7 days of publication of SRO).

S.R.O 1084(I)/2022 (Amendments in drugs (Appellate Board) rules 1976)

S.R.O 1085(I)/2022 (Amendments in drugs (Import and Export) rules 1976)

S.R.O 1086(I)2022 (Amendments in drugs (Federal Inspectors, Federal Drug Laboratory, Federal Government Analysts)) rules 1976

S.R.O 1087(I)/2022(Amendments in drugs (Licensing, Registering, Advertising) rules 1976)

Policy for Inspection of Manufacturing Site Abroad

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:-

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

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.

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.