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Rapid Alert: Falsified Products identified and Confiscated by the Regulatory Field Force of Punjab

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/02-24-07
Action Date16th Feb, 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementThe regulatory field force of Punjab has identified suspected samples of the following product in the market and sent them for analysis in the Drug Testing Laboratories. The Government Analyst has reported that these three products are falsified/spurious. The labelled stated manufacturer has informed that these samples are not manufactured and supplied by themselves in the market.

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoManufacturer
(as per label)
Duphaston 10mg Tablet
Dydrogesterone 10mg223298M/s. Highnoon Laboratories Ltd, 17-Km Multan Road, Lahore.
Femara 2.5mg TabletLetrozole 2.5mgTTT60M/s. Novartis Pharma Stein AG SCHAFFHAUSERSTRASSE
Oxidil 1g InjCeftriaxone 1g050KM/s Healthtek Pvt Ltd, Karachi
Threat to Public HealthThe use of these falsified products will result in the ineffective treatment of patients. Moreover, the safety and quality of the falsified products referenced in this alert are also unknown.
Action InitiatedThe 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 these product’s batches 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 ConsumersConsumers should not use products bearing these batches and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product, and should 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.

Rapid Alert: Contaminated Propylne Glycol (Batch # 1P03-202308194) Allegedly Produced By M/s. Shinghwa Amperex Technology (Dongying), China.

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/02-24-06
Action Date13th Feb, 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis No. RM-1-24-000027 dated 31-01-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by M/s. Biolabs (Pvt.) Ltd., Islamabad in compliance to letter vide No. 03-41/2023-QC dated 01-12-2023. Details of test/analysis report are given as under:

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoMfg DateExp. DateManufacturer
(as per label)		Remarks
Propylene Glycol
(Raw Material)		1P03-20230819426-08-202325-08-2025M/s. Shinghwa Amperex Technology
(Dongying) Co. Ltd., China.		The sample is declared substandard
for unacceptable levels of
Ethylene Glycol (EG) and Diethylene Glycol.
Risk StatementDi-Ethylene 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 InitiatedThe Regulatory Field Force has directed to take necessary action on above mentioned contaminated batch of Propylene Glycol and is investigating the entire supply chain of this batch. The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of propylene glycol. The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1. Recall Products: If any batch was manufactured using the same lot (1P03-202308194) of Propylene Glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.

2.      Hold Other Batches: All finished products manufactured from any other lot of propylene glycol of M/s. Shinghwa Amperex Technology (Dongying) Co. Ltd., China should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain.

3.      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.

4.      Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

5.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

6.      Follow Guidelines: Adhere to the pharmacopoeia 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. Before their release into the market, all finished products should be analyzed for EG/DEG contamination.
Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of 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 ConsumersConsumers 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.

Stakeholders Comments are invited on revision of Guidelines on Conduct of Clinical Trials in Pakistan

Asad Ullah Clinical Trials, Drugs

The Drug Regulatory Authority of Pakistan (DRAP) is revising Guidelines on Conduct of Clinical Trials in Pakistan with the aim to ensure the safety, quality, and efficacy of investigational products in clinical trials, as well as the ethical conduct and oversight of clinical research in Pakistan.

The revised guidelines cover various aspects of clinical trial activities, such as:

  • The regulatory framework and approval process for clinical trials in Pakistan
  • The roles and responsibilities of various stakeholders involved in clinical trial activities, such as DRAP, National Bio Ethics Committee, sponsors, investigators, and pharmaceutical associations
  • The requirements and procedures for obtaining informed consent, protecting the rights and welfare of trial participants, and reporting adverse events and serious adverse events
  • The standards and principles for designing, conducting, monitoring, recording, analyzing, and reporting clinical trials
  • The good clinical practice (GCP) requirements for clinical trial materials and investigational products
  • The data management and quality assurance systems for clinical trial data and documents
  • The post-trial obligations and follow-up measures for clinical trial sponsors and investigators

The revised guidelines are based on the best regulatory practices as per the International Council for Harmonisation (ICH) guidelines, and the World Health Organization (WHO) guidelines.

The revised guidelines are open for public comments until February 22, 2024. DRAP invites all the relevant stakeholders, such as pharmaceutical companies, research institutions, clinical trial organizations, health professionals, patient groups, and civil society organizations, to review the revised guidelines and provide their feedback and suggestions. Stakeholders can submit their comments and suggestions using prescribed format (click here to visit how to submit comments) via email to shafqat.hussain∂dra.gov.pk or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, PM health Complex, Park Road, Islamabad.

DRAP appreciates the cooperation and contribution of all the stakeholders in the development and improvement of the guidelines on conduct of clinical trials in Pakistan. DRAP hopes that the revised guidelines will facilitate and promote the conduct of high-quality, ethical, and reliable clinical trials in Pakistan, and ultimately benefit the public health and well-being of the people of Pakistan.

Draft-Guidelines-for-Conduct-of-Clinical-Research-in-Pakistan_06_02_24_AmendedDownload

Rapid Alert: Contaminated Glycerin (Batch # 1A2192K) Allegedly Produced By M/S KLM Palm Oleo BHD, Malaysia

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/02-24-03
Action Date01stFeb, 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementMs. Cibex Private Limited Pharmaceuticals, Karachi sent the sample of Glycerin to Central Drugs Laboratory Karachi for test/analysis that was used as a solvent in the manufacturing of oral liquid preparations. The batch was labelled as manufactured by Ms. KLK PALM OLEO SDN BHD, Malaysia. However, on analysis of a sample by the Central Drug Laboratory in Karachi, an unacceptable level of Ethylene Glycol was found. The details of the affected batch are as under:-

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoMfg DateExp. DateManufacturer
(as per label)		Remarks
Glycerin
(Raw Material)		IA2192K06-10-2205-10-24KLK Palm Oleo SDN BHD,
Malaysia		The sample is declared substandard
for unacceptable levels (0.1662%) of
Ethylene Glycol (EG)..
Risk StatementGlycerin contaminated with Ethylene Glycol (EG) when used in oral liquid preparations can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal..
Action InitiatedThe Regulatory Field Force has directed to take necessary action on above mentioned contaminated batch of Glycerin and is investigating the entire supply chain of this batch. The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of Glycerin. DRAP has directed the therapeutic industry to ensure the testing of this lot or any other lot of raw material prior to use in manufacturing of finished products.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1. Recall Products: If any batch was manufactured using the same lot (1A2192K) of glycerin that has been identified as contaminated, all finished products from local and export markets should be recalled.

2.      Hold Other Batches: All finished products manufactured from any other lot of glycerin of Ms. KLK PALM OLEO SDN BHD, Malaysia should be held. These products should be tested for EG/DEG contamination before releasing them into the supply chain.

3.      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.

4.      Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

5.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

6.      Follow Guidelines: Adhere to the pharmacopoeia 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 ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of 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 ConsumersConsumers 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.

Recall Alert: Drug Product; Recall of Contaminated Liquid Preparations

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/01-24-05
Action Date30th January 2024
Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
· General Public
Problem / Issue Government Analyst DTL Bahawalpur and DTL Rawalpindi have informed that following products are found to be of “sub-standard” quality due to presence of Ethylene Glycol (EG) impurity at unacceptable levels. Details of affected products is provided in table below.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No ManufacturerTest Results
Asthanil 60ml Syp
Ketotifen 1mg/5ml03-23M/s. Siza International (Pvt.) Ltd
18-Km Ferozpur Road, Lahore.		Ethylene Glycol: 2.896%
Does not comply
Virol Syrup
Ribavirin 5mg/5ml35080M/s. Raazee Therapeutics (Pvt.) Ltd.,
48-Km Lahore-Kasur Road, Lahore.		Ethylene Glycol: 3.31%
Does not comply
Torax DM Syrup
Dextromethorphan HBr 12.5mg & Diphenhydramine HCl 12.5mg110-23M/s. Siza International (Pvt.) Ltd.,
18-Km Ferozpur Road, Lahore.		Ethylene Glycol: 2.14%
Does not comply
Texcol EX Syrup
Acefylline Piperazine 45mg, Diphenhydramine HCl 8mg63833M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore.Ethylene Glycol: 0.985%
Does not comply
Texcol DM Syrup
Dextromethorphan HBr 10mg/5ml09953M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore.Ethylene Glycol: 1.19%
Does not comply
Allerphene Syrup
Chloepheniramine Maleate 2mg/5ml3002M/s. PDH Pharmaceuticals (Pvt.) Ltd., 19-Km Ferozpur Road, Lahore.Ethylene Glycol: 1.417%
Does not comply
Speczine Syrup
Promethazine HCl 5mg/5ml276M/s. Spectrum Laboratories (Pvt.) Ltd., 8-Km Raiwind Road, Lahore.Ethylene Glycol: 2.43%
Does not comply
Bronyl syrup


Nutraceutical cough preparationBL-013M/s. Florex Pharma Pvt Ltd, 25-Km Lahore-Jaranwala Road, Sheikhupura-Lahore.Ethylene Glycol: 0.12%
Does not comply
Action Initiated-All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase 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 through phone at +92 51 910 73 17, 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 ProfessionalsDRAP 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 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.

    Warning To Therapeutic Goods Manufactures on DEG/EG Impurities in Raw Materials: A Serious Threat to Therapeutic Goods Quality and Safety

    Asad Ullah Recall Alerts, Regulatory Updates

    The Drug Regulatory Authority of Pakistan (DRAP) has issued a warning to the therapeutic goods industry about the use of raw material contaminated with diethylene glycol (DEG) and ethylene glycol (EG) impurities, which can pose serious health risks to consumers.

    What is the issue?

    The Central Drugs Laboratory Karachi has declared another sample of raw material i.e. propylene glycol (PG) as substandard sent for test/analysis due to unacceptable levels of ethylene glycol.

    Propylene glycol, sorbitol and glycerin are used as solvents in the manufacturing of oral liquid preparations in the pharmaceutical and alternative medicines industry. When used in oral liquid preparations, these solvents can lead to serious health risks due to DEG and EG toxicity. When ingested, DEG and EG are metabolized into toxic metabolites that can affect the central nervous system, heart, and can cause kidney damage, which can be fatal.

    In the past two years, there have been international reports related to the adulteration of these raw materials with DEG and EG causing kidney damage and death of children in Gambia, Uzbekistan, and Indonesia. Industrial grade DEG and EG are used for various applications (solvents, antifreeze agent) in other industries.

    Earlier, several cases of substandard raw materials including PG and finished goods contaminated with DEG and EG have been reported from various part where investigations have suggested that the main problem lies with the integrity of supply chain of raw material which appears to be compromised. Consequently, action has been initiated against the culprits involved.

    What are the actions taken by DRAP?

    Despite repeated warnings and instructions, many therapeutic goods manufacturers have neglected to verify the quality and safety of their raw materials from authorized vendors. The Central Drug Laboratory, Karachi is currently analyzing both raw materials and finished products for EG and DEG contamination, following the pharmacopoeial standards and WHO guidelines for testing of EG and DEG in oral liquid preparations. To ensure the quality and safety of their products, manufacturers should test their raw materials for EG and DEG contamination before using them in their production processes to prohibit potential influx of contaminated products in the market.

    In view of the criticality of the matter and potential for untold human tragedy, the therapeutic goods industry is once again warned to screen raw materials (propylene glycol, glycerin and sorbitol) for contamination with EG and DEG before using these materials in the manufacturing of oral liquid preparations. Additionally, all finished products must be analyzed for EG and DEG contamination before their release into the market. DRAP also issued directives to nutraceutical and alternative medicine companies to ensure compliance and safeguard public health from contaminated products. Additionally, the industry is diected to recall any finished products that were manufactured using the contaminated lot/batch of propylene glycol, hold the affected batches of finished products and ensure testing of finished products for EG and DEG contamination before releasing them into the supply chain.

    DRAP urge pharma industry to take measures to prevent utilization of contaminated raw material in the manufacturing of liquid preparation including following:-

    • Implement a supplier qualification and verify the compliance of the suppliers with the relevant standards and regulations.
    • Verify traceability and authenticity of the raw material using unique identifiers such as barcodes or RFID tags to track their movement and origin throughout the supply chain.
    • Conduct regular risk assessments and monitor the performance of the suppliers, and take corrective actions if any issues are detected.
    • Educate and train the staff and the suppliers on the importance of preventing EG and DEG contamination, and the potential consequences of using contaminated solvents.
    • Verify the features that indicate the authenticity of the product, such as holograms, serial numbers, watermarks, or special packaging. The products should also be checked for any signs of poor printing, misspellings, inconsistent logos, tamper-evident seals or sturdy wrapping materials.

    DRAP is committed to ensure the safety and quality of therapeutic goods in Pakistan, and protecting the public from substandard and falsified products.