The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 69th meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.
Year: 2024
National Pharmacovigilance Cell (NPC), DRAP released draft Guidelines on National Pharmacovigilance System (Edition 03) seeking comments from stakeholders
The Drug Regulatory Authority of Pakistan (DRAP) has set up the National Pharmacovigilance Centre (NPC) in Islamabad to oversee the safety of medicinal products nationwide. The NPC collaborates with national and international entities to establish an effective pharmacovigilance system in Pakistan. Since 2018, Pakistan has been a full member of the World Health Organization Programme for International Drug Monitoring (WHO-PIDM) based at the Uppsala Monitoring Centre (UMC) in Sweden.
The NPC has developed a multi-channel reporting system, including electronic and manual reporting forms available through website and mobile applications for healthcare professionals and the public. The Pharmacovigilance Rules, 2022, apply a legal obligation of all pharmacovigilance stakeholders to establish their system and report the pharmacovigilance data to NPC.
The 1st edition of these guidelines was drafted as per the draft Pharmacovigilance Rules and had chapters and sections for the guidance of healthcare professionals, patients and registration holders. Subsequently, the National Pharmacovigilance Centre (NPC) issued separate guidelines for the above pharmacovigilance stakeholders and also Pharmacovigilance Rules, 2022 were officially notified vide S.R.O 540 (I)/2022 dated 22nd April 2022. Therefore, the NPC-issued 2nd edition of guidelines with the title “Guidelines on the National Pharmacovigilance System” which were prepared in line with Pharmacovigilance Rules, 2022. All those sections /chapters for the guidance of the above stakeholders were removed and the WHO PV indicators were incorporated in Chapter 11 in the 2nd edition of the guideline. This 3rd edition of these guidelines has been drafted in light of WHO recommendations in the form of Institutional Development Plans (IDP) made during its assessment of the National Regulatory System of the DRAP. As per WHO recommendation and DRAP’s Authority decision, the PRAEC has now been given an advisory role in relation to signal management and risk assessment; whereas, the NPC has been mandated to perform signal management and risk assessment process and to make decisions in the context of risk minimization and recommendation of regulatory actions to concerned Boards and Committees of the DRAP.
These guidelines are uploaded on the official website of DRAP on the 16th of September, 2024 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit the DRAP website or click here. Comments and suggestions can be forwarded via email to pv∂dra.gov.pk or can be posted at the mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.
Rapid Alert: Recall of Contaminated Liquid Preparations
Rapid Alert
| DRAP Alert No | No I/S/09-24-33 |
| Action Date | 10th September 2024 |
| Target Audience | · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. · General Public |
| Problem / Issue | The Directorate of Drugs Control (DDC), Punjab has identified contamination of Ethylene Glycol in following liquid preparations. Drug Testing Laboratories (DTLs) have declared these batches of products as Substandard based on their analysis which revealed the presence of Ethylene Glycol exceeding limits. T |
Therapeutic Good(s) Affected: –
The details of the affected batches are as follows:
| S# | Product Name | Composition | Batch No. | Manufactured by |
| 01 | Texcol EX Syrup 120ml Reg. No. 030897 | Aceylline Piperazine 45mg/5ml, Diphenhydramine HCl 8mg/5ml | 63864 | M/s. Razee Therapeutics (Pvt.) Ltd., Lahore |
| 02 | Speczine Syrup 120ml Reg. No. 012597 | Promethazine HCl 5mg/5ml | 609 604 YZ | M/s. Spectrum Laboratories, Lahore |
| 03 | Mexair Syrup 60ml Reg. No. 02665 | Terbutaline Sulphate 1.5mg/5ml | 05-23 02-22 | M/s. Siza Int., Lahore |
| 04 | Stazin Syrup 60ml Reg. no. 026326 | Cetrizine HCl 5mg/5ml | GI 83 | M/s. Munawar Pharma (Pvt.) Ltd., Lahore |
| 05 | Zevirol Expectorant syrup 120ml Reg. No. 009378 | Dipenhydramine HCl 13.5mg, Ammonium Chloride 131.5mg, sodium citrate 55mg, Menthol 1mg | 4031 | P.D.H. Laboratories Lahore |
| 06 | Stazin Syrup 60ml Reg. No. 026326 | Cetrizine HCl 5mg/5ml | GI83 | M/s. Munawar Pharma Lahore |
| 07 | Zevirol Expectorant syrup 120ml Reg. No. 009.78 | Diphenhydramine 13.5mg, Ammonium Choride 131.5mg | 4031 | M/s. P.D.H. Pharmaceuticals Lahore |
| 08 | Aphylin Expectorant Syrup Reg. No. 026635 | Aminophylline 32mg/5ml, Diphenhydramine 8mg/5ml, Amonium Chloride 30mg/5ml | 24C090 | M/s. Obsons Pharmaceuticals Lahore |
| 09 | Resfyl Syrup Reg. No. 057214 | Acefylline Piperzine 45mg/5ml, Diphenhydramine 8mg/5ml | 4A055 | M/s. Rasco Pharma Lahore |
| 10 | Zonid Suspension 120ml Reg. No. 022579 | Metronidazole 200mg/5ml | Z492 Z246 | M/s. Bloom Pharmaceuticals Hattar |
| 11 | Butamin Syrup 60ml Reg. No. 016630 | Salbutamol 2mg | 4016 | M/s. P.D.H Pharmaceuticals, Lahore |
| 12 | Nuocid Plus suspension 120ml Enlst. No. 0327660558 | Zingiber Officinale 20mg/5ml, Mentha Piperita 40mg/5ml | NC-S045 | M/s. Arber Pharma Lahore |
| Risk Statement | Di-ethylene Glycol (DEG) and Ethylene Glycol (EG) contaminated oral preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences |
| Action Initiated | -The manufacturers of products have been directed to immediately recall the defective batches of from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these defective batches of liquid products. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |
Minutes of 298th Meeting of Central Licensing Board held on 26th July, 2024
Rapid Alert: Recall of Contaminated Liquid Preparations
Rapid Alert
| DRAP Alert No | No I/S/09-24-32 |
| Action Date | 06th September 2024 |
| Target Audience | · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. · General Public |
| Problem / Issue | The Directorate of Drugs Control (DDC), Punjab has identified contamination with ethylene glycol and diethylene glycol in the following liquid preparations. Analysis from Drug Testing Laboratories (DTLs) has declared these products as Substandard |
Therapeutic Good(s) Affected: –
The details of the affected batches are as follows:
| S# | Product Name | Composition | Batch No. | Manufactured by |
| 01 | Cestonil Plus syrup Reg. No. 021843 | Thiamine 1.75mg, Riboflavin 2.62mg, Pyridoxine 1.54mg, Nicotinamide 10.50mg | 061357 | M/s. Razzee Therapeutics, Lahore |
| 02 | Texcol DM 10mg/5ml syrup Reg. No. 025034 | Dextromethorphan | 09980 | M/s. Razzee Therapeutics, Lahore |
| 03 | Speczine 5mg/5ml Syrup Reg. No. 012597 | Promethazine | 280 287 | M/s. Spectrum Laboratories, Lahore |
| 04 | Aphylin Syrup Reg. No. 026635 | Aminophylline 32mg, Diphenhydramine 8mg, Ammonium HCl 30mg | 24B056 | M/s. Obsons Pharmaceuticals, Lahore |
| 05 | Zolint Suspension Reg. No. 016494 | Furazolidone 25mg/5ml, Metronidazole 75mg/5ml | 24003 | M/s. Libra Private Ltd., Peshawar |
| Risk Statement | Di-ethylene Glycol (DEG) and Ethylene Glycol (EG) contaminated oral preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences |
| Action Initiated | -All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these defective batches of liquid products. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |
Rapid Alert: Crackdown Against Spurious/Falsified Drug Products
Rapid Alert
| DRAP Alert No | No I/S/09-24-31 |
| Action Date | 06th September 2024 |
| Target Audience | · Regulatory Field Force. · Healthcare Professionals – Physicians, Pharmacists, and Nurses. · Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions · General Public. |
| Problem Statement | The Directorate of Drugs Control (DDC) Punjab has detected the following falsified drug products based on their analysis from Drug Testing Laboratories (DTLs). |
The details of the identified products are as under: –
| S# | Product Name | Composition | Batch No. | Manufactured by (as stated on the label) | Test Results |
| 01 | Ativan 2mg Tablets | Lorazepam | 17C7019 | Purported to be manufactured by M/s. Pfizer Pakistan, Karachi | Spurious |
| 02 | Marfix 400mg Tablet | Cefixime | MK-0002 | M/s. Mirak Pharmaceutical, Lahore | Spurious |
| 03 | Payodine 10g/100ml Solution | Povidone-Iodine | 002709 | M/s. A.Mannan Lab, Karachi | Spurious |
| 04 | Froxime 400mg Capsule | Cefixime | FRX-400/C-6 | M/s. Froxx Pharmaceuticals, Karachi | Spurious & Misbranded |
| 05 | Noa-Xime 400mg Capsule | Cefixime | nx-00525-02 | M/s. Noa Hemis Pharmaceuticals, Karachi | Spurious & Misbranded |
| 06 | Biovim Injection | Benzyl Penicillin 500000 IU, Procaine Penicillin 1500000 IU | C. B-86 | M/s. Uniline Pharma, Karachi | Spurious |
| 07 | Novazone Plus Drench | Oxyclonazde 3% w/v, Levamisole HCl1.5% w/v, Cobalt Sulphate 0.075% /v, Selenium Selenite 0.035% | 061 | M/s. Uniline Pharma, Karachi | Spurious |
| Threat to Public Health | Spurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions. The safety and quality of the falsified products referenced in this alert are unknown. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock to halt the distribution/supply of this product. Information related to the supplier of this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of these products. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products 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 this product and shall contact 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 the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre All therapeutic goods must be obtained from 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. |
Recall Alert: Drug Products; Recall of 11 Substandard Batches from the Market
Recall Alert
| DRAP Alert No | No I/S/09-24-30 |
| Action Date | 06th September 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | The Directorate of Drugs Control (DDC) in Punjab and the Quality Control Board in Baluchistan have identified the following substandard batches of pharmaceutical products based on analyzing their samples from Drug Testing Laboratories, revealing out-of-specification results. The Details of affected product batches is tabulated below:- |
Therapeutic Good(s) Affected: –
| S# | Product Name | Active Ingredients | Batch No. | Manufactured by | Test Results |
| 01 | Zyocain gel 15g | Lidocaine HCL 2% | 244 275 | M/s. Pharmawise Laboratories, Lahore | Substandard |
| 02 | Metrorise injection | Metronidazole 500mg/100ml | LV 2303 | M/s. Pak risen Pharmaceuticals, Hattar | Substandard |
| 03 | Safemed Injection | Metronidazole 500mg/100ml | S-825 | M/s. Ahad International Pharmaceutical Ltd., DI Khan | Substandard |
| 04 | Lyosafe Infusion | Levofloxacin | L-784 | M/s. Ahad International Pharmaceutical Ltd., DI Khan | Substandard |
| 05 | Enzol-WFI injection | Sterile water for injection | 1240003 | M/s. Enzon Pharma, Lahore | Substandard |
| 06 | Oxytofas Injection | Oxytocin | OTI-1419 | M/s. Intervac (Pvt.) Ltd., Sheikhupura | Substandard &Misbranded |
| 07 | Painsa 75mg Injection | Diclofenac Sodium | PA420 | M/s. Wimits Pharmaceuticals, Lahore | Substandard |
| 08 | Midoven Injection | Furosemide | H-21924 | M/s. Venus Pharma, Lahore | Adulterated |
| 09 | Mencobal Injection | Mecobalamin | 083 084 | M/s. Treat Pharmaceutical Industry, Lahore | Adulterated |
| Action Initiated | –The manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock should be quarantined and returned to the supplier/ company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, by phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |
Minutes of 339th meeting of Registration Board held on 6th – 8th August, 2024
The Drug Registration Board convened 339th meeting on August 6 – 8, 2024, in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
S.R.O. 1324(l)12024 – Revision of Regulatory Fee Notification
In exercise of the powers conferred by sub-section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act,2012 (XXI of 2012), read with sub-rule (3) of Rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, the regulatory fees of various functions has been notified. The Notification as under:-
Orientation Session For Pharmaceutical Manufacturers on PIC/s GMP Guidelines
The Drug Regulatory Authority of Pakistan (DRAP) is dedicated to enhancing the regulatory framework to meet international standards and elevate the pharmaceutical sector in Pakistan. As part of these efforts, DRAP is aspiring membership of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) for inspectorates in the field of Good Manufacturing Practice (GMP) of drug products.
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
PIC/S is a mutual cooperative arrangement between regulatory authorities in the field of GMP for medicinal products. PIC/S aims to harmonize inspection procedures globally by developing common standards in GMP and facilitating cooperation and networking between competent authorities, regional, and international organizations, thereby increasing mutual confidence.
Virtual Orientation Sessions
To raise awareness in the industry about the PIC/S theme and GMP guidelines, and to facilitate a phased transition towards adopting these guidelines, DRAP will conduct a series of virtual orientation sessions for pharmaceutical manufacturers. The tentative schedule for the first two sessions is as follows, with further sessions to be announced later:
| Session | Date |
| Session 1 | 4th September, 2024 |
| Session 2 | 6th September, 2024 |
Interested participants are required to complete the registration form by 31st August, 2024. The virtual session links will be emailed to registered participants with the session agenda.