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.
Rapid Alert: Falsified Propylene Glycol in Supply Chain Market
Rapid Alert
| DRAP Alert No | No II/S/08-24-29 |
| Action Date | 22nd August 2024 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control Administrations 2. Therapeutic Goods Manufacturers |
| Problem Statement | Dow Chemical’s Singapore and the Incidents and Substandard/Falsified Medical Products (ISF) Regulation and Safety Unit, World Health Organization have informed DRAP that some miscreants are supplying falsified batches of Propylene Glycol with counterfeit Dow Chemical labelling in the supply chain market in Pakistan. The quality and safety of this material cannot be assured, and it should not be used in the manufacture of medical products. Details of identified falsified batches are as under:_ |
| Material | Batch/Lot No. | Manufacturer (as stated on the label) | Mfg. Date | Exp. Date |
| Propylene Glycol USP/EP | F9600L7PPA4 | Dow Europe GmbH | 18-10-2023 | 18-10-2025 |
| Propylene Glycol US/EP | F8900L8PPD6 | Dow Europe GmbH | Feb-2023 | Feb-2025 |
| USP Propylene | SS8900B3PPD5 | The Dow Chemical Company | 18/May/2023 | -Nil- |
| Risk Statement: | Diethylene glycol (DEG) and Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid 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 Regulatory Field Force has taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market. |
| Advice for Therapeutic Goods Manufacturers | Manufacturers of therapeutic goods are required to follow these instructions: 1. Recall Products: If any batch of finished product has been manufactured using the same batch of the propylene glycol that has been identified as contaminated, the retained sample should be immediately analysed and these finished products should be recalled from local and export markets if found contaminated. 2 Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG. 3. Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination. 4. Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products. 5. Follow Guidelines: Adhere to the pharmacopeial monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products. Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products. |
| Advice for Healthcare Professionals | DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of DEG/EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres. -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 stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately 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. |
DRAP Switched Over to Pakistan Single Window (PSW) for Regulatory Controls on Crossborder Trade at Karachi Custom Stations
The Drug Regulatory Authority of Pakistan (DRAP) is pleased to announce that, effective August 15, 2024, we have successfully transitioned from the Online Import Export System (OIES) to the Pakistan Single Window (PSW) for processing applications related to the clearance of commercial imports of raw materials and finished drug products at Karachi Seaport and Airport customs stations.
Pakistan Single Window (PSW) is an electronic portal enabling cross-border trade using standardized information and documents through a single entry point for all import, export, and transit-related regulatory requirements. The information is transmitted electronically, and individual data elements for clearance and regulatory approvals need only be submitted once. Authorized users who have completed the subscription process can access the PSW to perform cross-border procedures, including online payment/fees.
Key Highlights of the Transition:
- Single Declaration Release: DRAP officers are now electronically issuing Release Orders through a Single Declaration (SD) system, streamlining the import/export process for pharmaceutical products.
- Trade Automation: The new system allows for 24/7 electronic submission of cross-border trade applications, including online payment of fees and controlled data processing by authorized users.
- Single Entry Point: Users can now submit standardized information and documents just once, simplifying the application process.
- Clear Visibility and Application Tracking: The PSW system provides clear visibility of actions on applications, eliminating the need for physical visits for application follow-ups. It also allows for electronic calls on documents for any shortcomings.
DRAP Operations at PSW Include:
- Entity Registration: Onboarding of existing Drug Manufacturing Licenses (DMLs), product registrations, and importers with existing drug sale licenses.
- Raw Materials & Finished Drugs: Processing of drug import licenses (Form 5), clearance certificates for the import of raw materials, finished drugs, and controlled drugs.
- Clinical Trials, Tests & Analysis: Issuance of drug import licenses for test analysis (Form 6) and clearance certificates for the import of drugs/medicines for clinical trials.
- Hospital/Institutional Use & Donations: Import permits for unregistered/unavailable drugs and clearance certificates for donation medicines.
Additional Information:
- DRAP Notification: DRAP has issued a notification regarding this transition to ensure all stakeholders are informed and prepared for the new process.
- PSW User Manual: PSW has issued a comprehensive user manual to guide users through the new system, ensuring a smooth and efficient transition.
For further assistance, please contact us at 021-111-111-779 or email support∂psw.gov.pk.