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Series of Training on National Pharmacovigilance System for Registration holders (Manufacturers and Importers)

Asad Ullah General, Pharmacovigilance

The Drug Regulatory Authority of Pakistan (DRAP) has established the National Pharmacovigilance Centre (NPC) under the Division of Pharmacy Services. This initiative is aimed at ensuring the safety of therapeutic goods. With its endeavour, Pakistan became the 134th full member of the Programme for International Drug Monitoring (WHO-PIDM), Uppsala Monitoring Centre in 2018.

Subsequently, the DRAP notified Pharmacovigilance Rules, 2022 which outline the roles and responsibilities of pharmacovigilance stakeholders, including registration holders of therapeutic goods. The DRAP has also developed Guidelines on Good Pharmacovigilance practices for registration holders that outline step-by-step guidelines on the establishment of pharmacovigilance systems in pharmaceutical companies. The NPC has dedicated tools in place for the collection of adverse drug reaction reports (ADRs) from pharmaceutical companies (registration holders) such as E2B XML submission through dedicated email, and hard copy submissions via mailing address

Despite the above efforts of DRAP, very few pharmaceutical companies have established their pharmacovigilance centres and nominated their qualified persons for pharmacovigilance. Implementing pharmacovigilance rules, 2022 and establishing an effective pharmacovigilance system by all stakeholders, including registration holders is a prerequisite for ensuring the safety of medicines in Pakistan. This will reduce the risks associated with medications, thereby ensuring patient safety. This is why DRAP feels that there is a need to enhance the capacity of registration holders in respect to pharmacovigilance.

In this regard, the NPC, Division of Pharmacy Services, DRAP intends to conduct training of pharmaceutical companies (registration holders) on pharmacovigilance rules, guidelines and pharmacovigilance systems including collection and reporting of pharmacovigilance data. Three virtual training session will be conducted in the month of July 2024.

Rapid Alert: Busting of Illegal Manufacturing Site producing Unregistered Boostin (RBST) Injections

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo I/S/05-24-25
Action Date10th June 2024
Target Audience·         National Regulatory Field Force.
·         Distribution, Pharmacies and Medical Stores
·         Healthcare Professionals – Veterinarians, Chemists
·         Farmers/Consumers 
Problem StatementDuring a joint raid by DRAP and FIA, illegal manufacturing of Boostin Injections (Synthetic Recombinant Bovine Somatotropin Hormone) was unearthed at Chandio Village, Clifton, Karachi. A large quantity of raw materials used in the manufacturing of Boostin Plus 2g Injections, finished goods, empty cartridges/containers with needles, packing materials/stickers, and packing machinery were seized from the premises as per Form-2 under Section 18(1) of the Drug Act 1976.
Threat to Public HealthRBST (a synthetic recombinant Bovine Somatotropin hormone) injected into animals for enhancing their milk production was banned in the country due to serious side effects on health of animals and impact on those consuming milk and meat of such animals. The product is also banned in Europe, Canada, Australia etc.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities in markets to confiscate the product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force in order to ensure the removal of this products. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of this product.
Advice for VeterinarianDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link
Advice for Farmers/ConsumerFarmers/Consumers should not use this product. They shall contact their physician or healthcare provider(s) if the animal experienced any problem that may be related to using this product.

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; Water for Injection (Batch 989) by Zafa Pharmaceutical Pvt Ltd, Karachi

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/06-24-26
Action Date09th June 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 Federal Drug Inspector in Karachi collected a sample of Sterile Water for Injection and sent for laboratory analysis. Federal Government Analyst at CDL Karachi has declared Batch No. 989 of the product as substandard.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Sterile Water for Injection

Reg No. 030217
Water for InjectionBatch No. 989
 
Mfg Date:03-2023
Exp Date:03-2028		M/s. Zafa Pharmaceutical
Laboratories Private Limited Karachi.
Risk Statement:Using non-sterile water for reconstitution of injectable medications can lead to bacterial and fungal infections, and may cause poor dissolution of the powder. It could also result in precipitation or deactivation of the active pharmaceutical ingredient, posing significant health risks.
Action Initiated–The manufacturer has been directed to immediately recall the defected batch of product from the market. All pharmacists and chemist 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. 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 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 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.

    Voluntary Recall Alert: Drug Product; Cadlec 30mg/mL Injection by Brooks Pharma Pvt Ltd., Karachi

    Asad Ullah Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/05-23
    Action Date15th May 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 M/s. Brookes Pharma Private Limited, Karachi, has initiated a voluntary recall of all batches of Cadlec 30mg/ml Injection due to the presence of tiny floating particles found in retained samples. Previously, Ketorolac injection was also recalled by Fresenius Kabi, USA, and Hospira Inc. Additionally, Hikma Pharmaceutical, USA, also recalled the injection for the same reason.

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Cadlec Injection 30mg/ml

    Reg No. 095892
    		KetorolacAll Batches
    		M/s. Brookes Pharma
    Private Limited, Karachi
    Risk Statement:Administering products containing particulate matter may block blood vessels, leading to local irritation, swelling, tissue inflammation, blood clots, lung tissue scarring, and life-threatening allergic reactions.
    Action Initiated–The manufacturer has initiated recall of all batches of the affected product from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying this product. The remaining stock should be quarantined and returned to the supplier/ company. 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 these product and 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.

      Introducing Centralized Case Management System for Enhanced Efficiency and Transparency

      Asad Ullah General, Notifications, Press Releases

      The Drug Regulatory Authority of Pakistan (DRAP) has introduced a centralized case management system, aimed at boosting operational efficiency and ease of doing business processes for the therapeutic goods industry. This system is designed to monitor the processing of applications and to enable applicants to track their regulatory submissions and furnish additional details as required, marking as a significant step towards enhancing transparency and efficiency.

      All licensed / applicant of therapeutic goods manufacturers/importers/exporters/ clinical trial sites/ CROs etc can access this system on eAPP module (www.eapp.dra.gov.pk) of DRAP through their existing secured account credentials, effective from 29th May, 2024. This module ensures that submissions are forwarded to the Director of the concerned Divisions with visibility for applicants to track their cases and receive timely responses, under monitoring by the DRAP’s higher management.

      We are hopeful that implementation of this new system will significantly improve the visibility of application processing and streamline regulatory operations.

      Stakeholders-Task-ManagementDownload

      Rapid Alert: Drug Product; Falsified Froxime 100mg/5mL Powder for Oral Suspension

      Asad Ullah Recall Alerts
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      Rapid Alert

      DRAP Alert NoNo I/S/05-24-22
      Action Date27th May 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 StatementThe Provincial Inspector of Drug Tehsil Kallurkot, Dist. Bhakkar inspected the premises of Ms. Dar ul Shifa Pharmacy near THQ Hospital Tehsil Kallur Kot district Bhakkar and collected samples of Froxime Suspension (Batch no FRX-100/S-005; manufactured by Ms. Froxx Pharmaceuticals Plot No 87 KIA Karachi). The Government analyst DTL Rawalpindi has declared the Froxime Suspension as Substandard and Spurious.

      The product identification details are as under: –

      ProductCompositionBatch DetailsPurported to be Manufactured by
      (as per label)
      Froxime 100mg/5mL

      Powder for oral Suspension
       
      Reg No. 555210
      (It is fake number)
      		Cefixime USPBatch No.FRX-100/S-005

      Mfg. Date: 03-23
      Exp. Date:  02-25      		Ms. Froxx Pharmaceuticals
      Plot No 87 Korangi Industrial Area, Karachi.
      (It is a Fake company)

      Note: There is no product registered in DRAP with the name “Froxime Powder for Oral Suspension”, and there is no licensed manufacturing company named as “Froxx Pharmaceutical Karachi”.

      Threat to Public HealthSpurious 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.
      Action InitiatedThe Regulatory Field Force has been instructed to increase surveillance activities at health facilities (hospitals), as well as markets, and confiscate any such falsified products. All pharmacists and chemists working at distributions and pharmacies should immediately check their stock and stop supplying any suspected products.. The remaining stock should be quarantined immediately, and supplier information should be provided to the Regulatory Field Force (DRAP, Provincial and State Drug Control Administrations) 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 ConsumersConsumers 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 Product; Zaftolin 5mg/ml Solution by Zafa Pharmaceutical Pvt Ltd, Karachi

      Asad Ullah Recall Alerts

      Recall Alert

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      DRAP Alert NoNo I/S/05-24-21
      Action Date15th May 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 Provincial Drug Inspector, Karachi took the sample of Zaftolin Respiratory Solution for respirator. Federal Government Analyst, CDL Karachi has declared the Batch No. 104 of the product as of substandard quality. Details of the product are given as under:

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch DetailsManufactured by
      Zaftolin 5mg/ml
      Respiratory solution

      Reg No. 039618
      		SalbutamolBatch No. 104

      Mfg. Date: 06-23
      Exp. date: 06-26      		M/s. Zafa Pharmaceutical
      Laboratories Private Limited Karachi.
      Risk Statement:The impact of use of substandard Zaftolin solution for respirator on the basis of pH may cause sub optimal effect.
      Action Initiated–The manufacturer has been directed to immediately recall the defected batch of product from the market. All pharmacists and chemist 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. 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 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.

        Rapid Alert: Contaminated Lot of Sorbitol Identified in Karachi

        Asad Ullah Uncategorized
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        Rapid Alert

        DRAP Alert NoNo  II/S/04-24-19
        Action Date15th May 2024
        Target Audience·         Regulatory Field Force.
        ·         Therapeutic Goods industry
        ·         Manufactures of Oral liquid preparations
        Problem StatementThe Federal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis report No. RM-2-24-000136 dated 22-03-2024 declared the sample of Sorbitol (Batch 09-LM-023) sent to CDL Karachi by M/s. Herbiotics Healthcare Rawalpindi in compliance to letter vide No. 03-41/2023-QC dated 01-12-2023.

        Details of CDL test/analysis report are as under:

        Product NameManufacturer as per labelBatch No.Test ResultsLimits
        Sorbitol  M/s. Master Sweetener, Karachi09-LM-023Ethylene Glycol: 0.6431% Does not complyEthylene Glycol: NMT 0.1%  
        Risk Statement:Ethylene Glycol (EG) contaminated raw materials when used in oral liquid preparations can lead to serious health risks. When ingested, EG is 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 therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of Sorbitol. The Regulatory Field Force has also been instructed to seize all preparations manufactured using the same batch of Sorbitol if found in the market.
        Advice for Therapeutic Goods Manufacturers: –Manufacturers of therapeutic goods are required to follow these instructions:
         
        1.      Recall Products: If any batch was manufactured using the same lot of Sorbitol 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 same lot of sorbitol 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.      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.
        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 centers.
        Adverse reactions 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.  Further information on reporting problems to DRAP is available on this link.