Year: 2024
Rapid Alert: Drug Product; Suspected Falsified Rabies Vacine
Rapid Alert
| DRAP Alert No | No I/S/09-24-37 |
| Action Date | 27th September 2024 |
| Target Audience | · Regulatory Field Force. · Healthcare Professionals – Physicians, Pharmacists, and Nurses. · Hospitals, Clinics, Pharmacies and other Healthcare Institutions · General Public. |
| Problem Statement | DRAP has received information about the presence of a suspected rabies vaccine in the supply chain. The product is not registered by DRAP and may be a falsified product. |
| Product Name | Batch/Lot No. | Stated Manufacturer | Mfg. date | Exp. date |
| Rabies Vaccine, Human IP (SURE RAB) (unregistered) | RO10821 | M/s Bio-Med Private Limited, C-96, SITE No. 1, B.S. Rd. Indi, AREA, Ghaziabad (U.P.) – 201009,INDIA. | 10-2023 | 10-2026 |
| Threat to Public Health | Rabies vaccine is used for the prevention of rabies in children and adults resulting from dog bite. Falsified rabies vaccines pose a significant threat to public health as the safety and efficacy of such products cannot be established therefore failing to provide adequate immunity, leaving individuals vulnerable to rabies infection |
| 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 this product. |
| 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/09-24-36 |
| Action Date | 26th 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 has 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 are tabulated below:- |
Therapeutic Good(s) Affected: –
Human Use Products
| S# | Product Name | Composition | Batch No. | Manufactured by | Test Results |
| 01 | Painsa 75mg/3ml Injection Reg. No. 077269 | Diclofenac Sodium | PA415 | M/s. Wimits Pharmaceuticals (Pvt.) Ltd., Lahore. | Substandard |
| 02 | Metroin Infusion 100ml Reg.No 071279 | Metronidazole 500mg/100ml | MT24-058, MT24-060, MT24-061, MT24-062, MT24-063 | M/s. Saturn Pharmaceuticals (Pvt.) Ltd., Lahore. | Substandard |
Veterinary Use Products
| Sr. | Product Name | Composition | Batch No. | Manufactured by | Test Results |
|---|---|---|---|---|---|
| 03 | Oxytocin Injection Reg.No 019928 | Oxytocin 10 I.U/ml | V6-143 | M/s. ISIS Pharmaceutical & Chemical Works, Karachi. | Substandard |
| 04 | Selmec Injection 50ml Reg.No. 071087 | Ivermectin 20mg/ml | SN-113 | M/s. Selmore Pharmaceuticals (Pvt.) Ltd., Lahore. | Substandard |
| 05 | Rasomycin-10 Injection Reg.No. 003791 | Oxytetracyclin 100mg/ml | VJ. 1340 | M/s. Star Laboratories (Pvt.) Ltd., Lahore. | Adulterated |
| 06 | Rasomycin LA 20% Injection Reg.No. 003791 | Oxytetracyclin 200mg/ml | VG. 1626 | M/s. Star Laboratories (Pvt.) Ltd., Lahore. | Adulterated |
| 07 | Rasomycin-5 Injection Reg.No 003791 | Oxytetracyclin 50mg/ml | VK. 1467 | M/s. Star Laboratories (Pvt.) Ltd., 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 9255969, 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. |
Rapid Alert: Crackdown Against Spurious/falsified Drug Products
Rapid Alert
| DRAP Alert No | No I/S/09-24-35 |
| Action Date | 24th 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 identified products and their batch details are as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label) | Test Results |
| 01 | Solveron 10mg Tablets | Dydrogesterone 10mg | SVN-001 | M/s. Solvay, Plot# 32, Sector 2, Highway Petaro Road, Jamshoro. | Spurious |
| 02 | Carenol Syrup 450ml | Ammonium chloride 125mg/5ml, Sodium Citrate 55mg/5ml, Chlorphenramine Maleate 2.5mg/5ml | CL-012 | M/s. Well Care Pharmaceuticals, A/7 P.S.I.E. Sargodha. | Spurious and Misbranded |
| 03 | Procain Penicillin Fort 4000000 I.U. Injection | Procaine Penicillin 3000000 I.U., Benzyl Penicillin 1000000 I.U | 140475 | M/s. Yanzhou Xier Kangtai Pharm. Co. Ltd., China. Sole agent: United International, 301 Madian Center, Plot No. MR-1/122, 3rd Floor, Kutchi Gali No. 2, Marriot Road, Karachi. | Spurious |
| 04 | Simgesic Tablet | Tramadol HCl 37.5mg, Paracetamol 325mg | B1985 | M/s. Siam Pharmaceutical, Plot No. 217, Industrial Triangle, Kahuta Road, Islamabad. | Spurious and Misbranded |
| 05 | Meronem 500mg Injection | Meropenem 500mg | 4B23D121 | ACS Dobfar S.p.A Viale Addetta 4/12, Tribiano, Milan Italy. Packed and Marketed by: Pfizer Pakistan Limited Karachi. | Spurious and Substandard |
| 06 | Meronem 1g Injection | Meropenem 1gm | 4A23A31 | ACS Dobfar S.p.A Viale Addetta 4/12, Tribiano, Milan Italy. Packed and Marketed by: Pfizer Pakistan Limited Karachi. | Spurious and Substandard |
| 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 is 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 this product. |
| 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. |
Invitation to Bid (Provision of high speed redundant internet connectivity services at DRAP Headquarters, Islamabad)
Recall Alert: Drug Product; Promass 1g/100mL Inf by M/s Treat Pharmaceutical, Bannu
Recall Alert
| DRAP Alert No | No I/S/09-24-34 |
| Action Date | 23rd September 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | The Provincial Drug Inspector, Dera Ismail Khan, KPK collected the samples of Promass 1g Infusion and sent for analysis. The provincial Drug Testing Laboratory, KPK, Peshawar has declared batch No 034 of Promass 11g Inf, manufactured by the M/s Treat Pharmaceutical Industry, Bannu, as a substandard product. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Promass 1gm/100ml Inf Reg.No. 075336 | Paracetamol | Batch No. 034 Mfg Date:01-07-2023 Exp Date:30-06-2025 | M/s. Treat Pharmaceutical Industry (Pvt.) Ltd, Kohat Road, Bannu |
| Risk Statement: | Identification of visible particles in infusion products is a serious indicator of substandard quality, which can lead to significant health risks including severe reactions such as shivering, high fever, arterial blockages, infarction and more serious adverse events. |
| Action Initiated | –The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of products. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) also increased surveillance in the market to ensure the effective recall of defective products(s). –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 by Email at gsms∂dra.gov.pk. –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 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 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. |
Decisions of 69th Meeting of Medical Device Board; Deficiency letters for Medical Devices Applications
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.
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. |