Recall Alert; Drug Product: Phenerzine Elixir (Batch # 037) by M/s Epoch Pharmaceuticals (Pvt) Ltd., Karachi

Recall Alert

DRAP Alert NoNoII/S/07-22-20
Action Date2nd August, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions
3. General Public
Product(s) Affected Phenerzine Elixir,
Company: M/s Epoch Pharmaceuticals (Pvt) Ltd., Karachi
Batch No. 037
Manufacturing Date: March-2022,
Expiry Date: March-2024
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Phenerzine Elixir bearing Batch No. 037 and declared it as Adulterated and Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms@dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

-Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Recall Alert; Drug Product: Faasgablin 75mg Capsules (Batch # 2210C001) by M/s FAAS Pharmaceuticals (Pvt) Ltd., Karachi

Recall Alert

DRAP Alert NoNoII/S/07-22-19
Action Date28th July, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions
3. General Public
Product(s) Affected Faasgablin 75mg capsules,
Company: M/s FAAS Pharmaceuticals (Pvt) Ltd., Karachi
Batch No. 2210C001
Manufacturing Date: January-2022,
Expiry Date: January-2024
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Faasgablin 75mg capsules bearing Batch No. 2210C001 and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch(s) of product to the company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms@dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

-Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

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.

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 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)

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:-