The 3rd meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) was held in the Committee Room of the Drug Regulatory Authority of Pakistan (DRAP) on the 17th of September, 2023. The minutes of meeting are attached hereunder:-
Pharnacovigilance
The National Pharmacovigilance Center, DRAP urge the manufacturers and importers to nominate Pharmacovigilance Officer to ensure safe use of drugs.
Pharmacovigilance is the science and practice of monitoring the safety and efficacy of drugs, both before and after they are marketed. It is a vital aspect of ensuring public health and patient safety, as well as complying with regulatory requirements and ethical standards.
Pharmacovigilance officers are professionals who are responsible for collecting, analyzing, and reporting data on adverse drug reactions, drug interactions, and other potential safety issues. They also conduct risk assessments, implement risk management plans, and communicate with health authorities, health professionals, and patients.
The National Pharmacovigilance Centre at Drug Regulatory Authority of Pakistan urges the pharma industry to nominate or appoint pharmacovigilance officers for their products, as this will ensure the highest standards of quality and safety for their customers and patients. Pharmacovigilance is not only a legal obligation but also a social responsibility. Focusing on pharmacovigilance can enhance reputation, credibility, and competitiveness of a product in the global market.
According to the Pharmacovigilance Rules, 2022, notified by the Drug Regulatory Authority of Pakistan (DRAP), it is the legal obligation of the pharma industry to nominate or appoint a pharmacovigilance officer for products registered under the DRAP Act, 2012. The pharmacovigilance officer is required to perform the following duties:
- To collect, record, and report adverse events and other safety data related to the product to the National Pharmacovigilance Centre (NPC) within the specified time frame.
- To conduct periodic safety update reports (PSURs) and risk-benefit assessments of the product and submit them to the NPC.
- To implement risk management plans (RMPs) and risk minimization measures (RMMs) for the product as per the NPC’s recommendations.
- To ensure compliance with the pharmacovigilance rules and guidelines issued by the NPC and DRAP.
- To maintain pharmacovigilance records and documentation for at least 10 years.
“The NPC was established by DRAP in July 2022 under the Pharmacovigilance Rules, 2022, with the aim to enhance the pharmacovigilance activities in the country . The NPC is responsible for collecting, analyzing, monitoring, and preventing adverse effects of therapeutic goods, as well as reviewing and assessing safety data, conducting risk evaluations, and communicating with health authorities, health professionals, and patients. The NPC also provides training, guidance, and support to the provincial or regional pharmacovigilance centres, public health programs, and product registration holders.”
Rapid Alert: Urgent Recall of Suspected Products for Contamination of DEG / EG
Rapid Alert
Urgent Recall of Suspected Product for contamination of DEG / EG
| DRAP Alert No | NoI/S/02-23-8 |
| Action Date | 20th February 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions 4. General Public |
| Problem Statement | Medical Control Agency, Gambia has issued a Safety Alert Ref: – MCA/AD/23/MJK(029) dated 13th February,2023 for KOF Relief Syrup bearing Batch# L394, manufactured by M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan due to presence of Ethylene Glycol (EG) at unacceptable levels. DRAP Inspectorate has initiated the investigation based on this information, and decided to recall all the suspected products manufactured by the firm using the same source of excipient i.e Glycerin and Propylene Glycol (PG). The details of suspected contaminated products are as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Composition | Batch # | Manufactured by (as stated on label) |
|---|---|---|---|---|
| 1 | Bromgen Syp 100mL (Reg. Export Only) | Bromhexine HCl | L392 | M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan |
| 2 | Kof Relief Syp 100mL (Reg, Export Only) | Chlorpheniramine Maleate Ammonium Chloride Sodium Citrate Menthol Green Banana Flavour | L394 | -do- |
| 3 | Macofen Syp 100mL (Reg, Export Only) | Ibuprofen | L395 | -do- |
| 4 | Vomitil Suspension 120mL (Reg, Export Only) | Domperidone | L400, L408, L414, | -do- |
| 5 | Asperfin Syp 60mL | Ketotifen | L401 | -do |
| 6 | Davis Tonic Syrup (250mL, 120ml) | Vitamin B12 Vitamin B1 HCl Vitamin B2 Vitamin B6 Vitamin B3 Folic Acid Vitamin B5 Sodium Glycerophosphate Manganese Sulphate Ferric Ammonium Citrate | CS07, CS20, CS21, CS23, CS30, CS31, CS42, CS70, CS71, CS159 | -do- |
| 7 | Zinc Syp 60mL | Zinc Sulphate Monohydrate | CS06, CS36, CS37, CS38, CS39, CS45, CS46, CS47, CS48, CS60, CS75, CS76, CS80, CS81, CS83, CS92, CS93 | -do- |
| Action Initiated | The manufacturing company has been directed to immediately recall the suspected batches of these products from the market. All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying these batches of products. The remaining stock should be quarantine and return to the supplier / company. 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 institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products. -Adverse reactions or quality problems experienced with the use of these product shall 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 these products 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, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. -All therapeutic goods must be obtained from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |
Minutes of 1st Meeting of Pharmacovigilance Risk Assessment Expert Committee (PRAEC) held on 12-October, 2022
1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) was held in the Committee Room of the Drug Regulatory Authority of Pakistan (DRAP) on the 12th of October, 2022. The minutes of meeting are attached hereunder:-
DRAP issued Guidelines on Management of High Alert Medication
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 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.
High Alert medicines are those that have a high risk of causing injury or harm if they are misused or used in error. NPC, DRAP has issued a a Guidelines on Management of High Alert Medication to illustrate recommended practices for safe handling of those drug products that are classified as High Alert Medication (HAM).
The main objective for issuing this guidance document is to support healthcare professionals working at hospitals and healthcare services providing institutes for ensure safe practices for prescribing, dispensing, administration and monitoring of high alert medication (HAM) and applies to all healthcare settings and healthcare professionals involved in the 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 was uploaded on the official website of DRAP dated 16th June, 2022 with request of comments submissions by the stakeholders. The National Pharmacovigilance centre, Division of Pharmacy Services has finalized the documents after careful evaluation of the comments and input received from internal and external stakeholder consultation.
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 to view the Guidelines on Management of High Alert Medication (Edition 01). For more information related the regulatory guidelines and guidance documents issued by the DRAP please navigate to the Publications > Guidelines tab of our website.
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)