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Rapid Alert: Substandard Propylene Glycol (Batch # G01821UG) claimed to be manufactured by SK Picoglobal Korea.

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo  I/S/03-24-12
Action Date8th March 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementMs. MKB Pharmaceuticals (Pvt) Ltd., Peshawar sent the sample of Propylene Glycol (PG) to Central Drugs Laboratory Karachi for test/analysis that was used as a solvent in the manufacturing of oral liquid preparations. The batch was claimed to be manufactured by SK picoglobal Co. Ltd. Korea. Analysis of the sample by the Central Drug Laboratory, Karachi detected unacceptable level of Ethylene Glycol.

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoMfg DateExp. DatePurported to be Manufactured by
(as per label)		Remarks
Propylene Glycol
(Raw Material)		G01821UG12-08-202311-08-2025SK Picoglobal Co. Ltd. Korea.The sample is declared substandard
for unacceptable levels of Ethylene Glycol (0.4671%).
Risk StatementPropylene Glycol (PG) 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 manufacturer has been instructed to recall finished products that were manufactured using the contaminated 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. DRAP has directed the therapeutic goods industry to hold finished products manufactured from any other lot of propylene glycol of Ms. SK picoglobal Co. Ltd. Korea and ensure testing of finished products for EG/DEG contamination before releasing them into the supply chain.
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 (YF01200730) 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 SK picoglobal Co. Ltd. Korea 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 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 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.

Switching Over to Pakistan Single Window (PSW) for Drug Import License and Import Release of Donations Medicines

Asad Ullah Drugs

The Drug Regulatory Authority of Pakistan has switched over submission, processing and release order of Drug Import License and Import release of donation medicines on Pakistan Single Window (PSW).

Drug Import License (DIL)

All Drug Manufacturing License (DML) holder companies are enabled o submit applications for all type of Drug Import License form March 05, 2024 through PSW System..

Import of Donations

All registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs are required to submit applications for import clearance on through PSW System from February 29, 2024

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Rapid Alert: Contaminated Propylene Glycol Identified and Confiscated

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo I/S/02-24-11
Action Date07th March 2024
Target Audience1. Therapeutic Goods industry
2. Manufactures of Oral liquid preparations
Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi has identified contaminated Propylene Glycol (Raw material) by detecting highly unacceptable levels of Ethylene Glycol in the seven different samples of Propylene Glycol which were sent to the laboratory by the Federal Inspector of Drugs Lahore. 

Out of the seven samples collected from different containers, six of them had labels indicating that they were from Batch#C856H85R55 and were labelled as manufactured by Dow Chemicals, Thailand. However, one of them (sample 7) had a label indicating that it was from batch F8900L8PPD6 and was labelled as manufactured by Dow Chemicals, Germany. Upon further investigation, it seems that none of the samples were actually manufactured by Dow Chemicals and the labels were false. The analysis reveals that these samples were highly contaminated.

It is important to note that on January 11, 2024, a rapid alert was also issued for contaminated Propylene Glycol with batch number C815N3OR41, which was labelled as being manufactured by Dow Chemicals, Thailand. However, Dow Chemicals, Thailand has clarified to DRAP that it was not their original product and was falsified by some miscreants. The company also analyzed the retained samples of the original product and shared an analysis report, which showed that it was in compliance with the required specifications.
Risk StatementDiethylene glycol (DEG) and Ethylene Glycol (EG) contamination in Propylene Glycol (PG) can lead to serious health risks when used in oral liquid preparations. Upon ingestion, these chemicals (EG and DEG) are converted into toxic metabolites which can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
Action TakenThe 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 batches were produced using the same lots of Propylene Glycol that have been identified as contaminated, it is crucial to test both the raw materials and finished products for contamination immediately. If any contamination is found, the affected products should be recalled promptly from the local and export markets.

2.      Hold Other Batches: All finished products manufactured from propylene glycol 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 of EG and DEG.

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

5.      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.

DRAP’s 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.

Guidelines on Risk Based Sampling and Testing of Drugs; Comments invited on draft Document

Asad Ullah Drugs, General ,

At the Drug Regulatory Authority of Pakistan (DRAP), our commitment to public health and safety drives our actions. We recognize that ensuring the quality and efficacy of pharmaceutical products is paramount. To achieve this, we emphasize risk-based sampling and testing strategies for assuring Safety and Quality of therapeutic goods to safeguard public health.

These Guidelines reflect a structured approach on regulatory oversight by allocating resources efficiently by prioritizing sampling collection, testing, and surveillance based on risk levels. This ensures that critical aspects of drug quality receive the attention at first and enable focusing regulatory efforts to high-risk areas. The draft guidelines are prepared based on the recommendation of ICH Q9 (Quality Risk Management), WHO working document QAS/15.630, and USP-PQM guidance document for implementing risk-based post-marketing quality surveillance in low and middle-income countries.

DRAP invites all interested parties and relevant stakeholders to provide their comments and inputs on the draft guideline. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to mehwish.tanveer∂dra.gov.pk with a copy to mahvash.ansari∂dra.gov.pk or can be posted at the following mailing address: Assistant Director (QC-II), Quality Assurance & Laboratory Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP appreciates your participation and contribution to this consultation process.

GUIDELINES ON RISK-BASED SAMPLING & TESTING OF DRUGSDownload

Recall Alert: Drug Product; DXL 60mg Capsule (Batch # 23136) by M/s. Titlis Pharma Lahore

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo II/S/02-24-09
Action Date27th February, 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 etc.
Problem / Issue The Secretary, PQCB Baluchistan has reported that samples of “DXL 60mg Capsule” bearing Batch No. 23136 manufactured by M/s. M/s. Titlis Pharma, 528-A Sundar Industrial Estate, Raiwind Road, Lahore. has been declared as “Substandard” by Government Analyst, Drug Testing Laboratory, Baluchistan.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
DXL 60mg Capsule
 
Reg.No 097679		DexlansoprazoleBatch No.  2336
 
Mfg. Date: 03-23
Exp. date: 03-25		M/s. Titlis Pharma,
528-A Sundar Industrial Estate,
Raiwind Road, Lahore.
Risk Statement:The use of substandard dexlansoprazole capsules may lead to untoward adverse drug reactions and may generate an unpredictable response based on individual variability.
Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan 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 product. 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) has 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.

    Recall Alert: Drug Product; Mencobal 500mcg Injection (Batch # 082) by M/s. Treat Pharmaceutical Industry (Pvt.) Ltd.,Bannu.

    Asad Ullah Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/02-24-08
    Action Date27th February, 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 etc.
    Problem / Issue The Secretary, PQCB Baluchistan has reported that samples of Mencobal Injection bearing Batch No. 082 manufactured by M/s. Treat Pharmaceutical Industry (Pvt.) Ltd., Bannu, has been declared as “Substandard” by Government Analyst, Drug Testing Laboratory, Baluchistan.

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch No Manufacturer
    Mencobal 500mcg Injection
     
    Reg.No 075537    		MecobalaminBatch No. 082
     
    Mfg. Date: 06-23
    Exp. date: 06-25    		M/s. Treat Pharmaceutical Industry
    (Pvt.) Ltd., A-37 Small Industrial Estate,
    Township, Kohat Road, Bannu.
    Risk Statement:The impact of the use of substandard injectable preparations can be serious as it may lead to infection and others adverse reactions or even sepsis.
    Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan 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 product. 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) has 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.

      Recall Alert: Drug Product; SN ZOR 200mg/5mL Suspension (Batch # 342) by M/s. S.N.B Pharma (Pvt) Ltd. Peshwar

      Asad Ullah Recall Alerts

      Recall Alert

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      DRAP Alert NoNo II/S/02-24-10
      Action Date26th February, 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 etc.
      Problem / Issue The Federal Government Analyst, CDL Karachi has declared the Batch No. 342 of product “SN Zor 200mg/5mL suspension for oral use, manufactured by S.N.B Pharma (Pvt) Ltd. Peshawar as Substandard for non-complying assay result.

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch No Manufacturer
      SN Zor 200mg/5mL Suspension
       
      Reg No. 074547      		AzithromycinBatch No. 342

      Mfg. Date: 08-23
      Exp. date: 08-25      		M/s. S.N.B Pharma
      (Pvt) Ltd. Peshawar
      Risk Statement:The impact of the use of substandard powder for oral suspension on the basis of low assay may cause sub-optimal effects and therapeutic failure.
      Action Initiated-The manufacturer has been directed by the Secretary PQCB Baluchistan 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 product. 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) has 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.

        Decisions of 64th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

        Asad Ullah Medical Devices Board

        The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 64th 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.

        Letter-of-Deferred-Products-M-64Download

        Important Notice to INGOs, NGOs, Hospitals and Government Programs/Departments Importers of Donated Drugs in Pakistan

        Asad Ullah Drugs, General

        The Drug Regulatory Authority of Pakistan (DRAP) and the Pakistan Single Window (PSW) have implemented an automated clearance system for the importation of donated drugs in Pakistan. This system aims to optimize and expedite the efficiency of the pharmaceutical supply chain in Pakistan and ensure a seamless and transparent delivery of donated drugs.

        PSW Subscription Required for Donated Drugs Importation in Pakistan

        To participate in this system, all registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs importation need to acquire their PSW Subscription promptly.

        The PSW Subscription is a pivotal step in ensuring a smooth and sustainable pharmaceutical supply chain in Pakistan. Your subscription significantly contributes to the optimization of drug distribution, allowing us to collectively make a more substantial impact on public health.

        How to Subscribe in 6 Easy Steps:

        • Visit the PSW website to access detailed instructions, user manuals, and demo videos.
        • Follow the straightforward subscription process and complete your subscription efficiently.
        • If you have any questions or require assistance during the subscription process, contact the PSW Support team at 021-111-111-779 or reach out via email at support∂psw.gov.pk.
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