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Month: October 2024

Implemmentation of Industry E-Reporting System for Reporting of Adverse Drug Reactions by Registrtaion Holders

Asad Ullah Drugs, Pharmacovigilance

The Drug Regulatory Authority of Pakistan (DRAP) has launch the Industry e-reporting System for Individual Case Safety Reports (ICSRs). This new system, developed in collaboration with the Uppsala Monitoring Centre (UMC), aims to simplify and streamline the submission process for registration holders, including manufacturers and importers of therapeutic goods. The National Pharmacovigilance Centre (NPC), established under the Division of Pharmacy Services, will oversee this initiative to ensure the safety of therapeutic goods, in line with the Pharmacovigilance Rules, 2022.

Since its inception, DRAP has been committed to promoting transparency and facilitating document submission through various tools. The new Industry e-Reporting System will allow registration holders to submit ICSRs via two modules: E2B XML submission and manual data entry for non-E2B pharmaceutical companies. Access to this system will be secure, with two accounts provided per registration holder.

Following a successful pilot project with a selected number of registration holders, DRAP is now extending the system’s scope to all registration holders. Starting from 8th November 2024, all future ICSRs must be submitted through this system. For further guidelines, please refer to the “Industry e-Reporting Manual for Registration Holders” available on the DRAP website.

We appreciate your cooperation in ensuring the safety and efficacy of therapeutic goods in Pakistan.

Implemenation letter of Industry e-reporting systemDownload

Directive of Registartion Board; Submission of Summary of Product Characteristics (SmPC), Prescribing Information(PI) and Patinet Leaflet(PIL)

Asad Ullah Drugs

Registration Board in 340th meeting held from 1st October to 2nd October 2024, directed applicants to submit the Summary of Product Characteristics (SmPC) including Prescribing Information (PI) along with Patient Information Leaflet (PIL) against section 1.5.14 of CTD for the Finished Pharmaceuticals Product (FPP).

It is hereby circulated for compliance and information of all stakeholders.

CIRCULAR-SmPC-PILDownload

Career Opportunities: Applications are invited for Various Positions in DRAP

Ijaz Mustafa Careers, General

The Drug Regulatory Authority of Pakistan (DRAP) employs over 500 people from a range of educational backgrounds, who have the skills and experience to perform regulatory operational services under the DRAP Act 2012. These include professionals both technical (qualifications in medicine and pharmacy-related sciences, etc.) and non-technical (qualifications in law, information and communication technology, accounts, human resources management, etc.)

DRAP is mandated to provide effective coordination and enforcement of The Drugs Act, 1976, and harmonization of inter-provincial trade and commerce of therapeutic goods. Being the national regulatory body for therapeutic goods, DRAP performs various regulatory functions of therapeutic goods including licensing of establishments, product registrations/marketing authorizations, pharmacovigilance, post-market surveillance and market control, regulatory inspections, laboratory testing, clinical trials oversight and lot release of biologicals.

Details of Vacant Positions advertised are as below.

46×4-and-48×4-Ad-25-10-24Download

Voluntary Recall Alert: Drug Product; Neo-Pyrolate Injection (Batch # 105B24) Manufactured by M/s Brookes Pharma (Pvt.) Ltd, Karachi.

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Recall Alert

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DRAP Alert NoNo I/S/11-24-46
Action Date28th October 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 voluntary recall of the following product through public notice. The details of the product are as below:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Neo-pyrolate Injection IV
 
1ml × 10’s		Glycopyrrolate + Neostigmine MethylsulphateBatch No. 105B24
 
Mfg. date: 02-2024
Exp. date: 02-2026		M/s Brookes Pharma (Pvt.) Ltd, Karachi.
Risk Statement:The use of substandard injection may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions.
Action InitiatedThe field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to conduct market surveillance for the detection of the presence and removal of the recalled batches from the market.
Advice for Healthcare ProfessionalsAll pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the mentioned product. The remaining stocks should be quarantined and returned to the supplier/company. The 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).  

-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 products bearing the affected batch number(s) and should 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 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; Famila 150mg Injection (Batch # 083) By Zafa Pharmaceutical Laboratories, Karachi

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    Recall Alert

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    DRAP Alert NoNo I/S/10-24-41
    Action Date24th October 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 Federal Inspector of Drugs, Karachi collected the samples of Famila 150mg Injection and sent for test / analysis. The Central Drugs Laboratory, Karachi has declared batch No. 083 of Famila Injection, manufactured by M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi, as a substandard product.

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch DetailsManufactured by
    Famila 150mg Injection

    Reg.No. 015615
    		Medroxyprogesterone
    acetate    		Batch No. 083
     
    Mfg Date: 02-2023
    Exp Date: 02-2029    		M/s. Zafa Pharmaceutical
    Laboratories, Karachi
    Risk Statement:To comply with the Sterility testing for injections is crucial to ensure that the product is free from viable microorganisms. The samples of above mentioned product have been reported substandard based on sterility. The use of the said medicine may lead to transmission of blood borne infections and 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 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 Propylene Glycol (Batch# YF01230522)

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      Rapid Alert

      DRAP Alert NoNo  I/S/10-24-38
      Action Date25th October, 2024
      Target Audience1. Regulatory Field Force.
      2. Therapeutic Goods industry
      3. Manufactures of Oral liquid preparations
      4. Healthcare professionals
      Problem StatementThe Federal Government Analyst at Central Drugs Laboratory (CDL) Karachi has identified a contaminated batch of Propylene Glycol which has been declared substandard vide Report No. RM-8-24-000486 dated 19-09-2024. Samples of this Propylene Glycol (Raw material) were sent to CDL Karachi by a licensed pharmaceutical manufacturer in compliance with DRAP advisory on solvent testing. The manufacturer has been stopped from using the contaminated material and its supply chain is under investigation.

      The product identification details are as under: –

      Therapeutic Good Affected:-

      ProductBatch No*Mfg DateExp. DateManufacturer Name
      (as per label)      		Remarks
      Mono Propylene Glycol
      (Raw Material)      		YF0123052222-May-202321-May-2025M/s. Dongying Hi-Tech Spring Chemical Industry Co. Ltd., China.
      [The material found in the packaging with the label of this manufacturer, however product authenticity and supply chain integrity are under investigation and yet not confirmed.]      		The sample is declared substandard
      due to conatmination of Ethylene Glycol.

      Note: On February 13, 2024, DRAP issued a Rapid Alert regarding contaminated Propylene Glycol (Batch #1P03-202308194). The investigation revealed that a falsified product had been packaged and labelled as being manufactured by Dongying Hi-Tech Spring Chemical Industry Co., Ltd. in China. The manufacturer also provided Certificate of Analysis (CoAs) to DRAP showing that the original product was not contaminated and analysis of retained samples met all required specifications.

      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 manufacturer has been instructed to halt the consumption of the contaminated material, and an investigation into the supply chain is underway. The Regulatory Field Force has increased surveillance to identify the contaminated batch of Propylene Glycol in the market. DRAP has strictly prohibited manufacturers of therapeutic goods from using Propylene Glycol without testing for Ethylene Glycol (EG) and Diethylene Glycol (DEG) levels.
      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 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 the same lot of propylene glycol 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 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.

      Rapid Alert: Unregistered and Falsified RBST Injection Confiscated

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      Rapid Alert

      DRAP Alert NoNo I/S/10-24-40
      Action Date24th October 2024
      Target Audience·         National Regulatory Field Force.
      ·         Distribution, Pharmacies and Medical Stores
      ·         Healthcare Professionals – Veterinarians, Chemists
      ·         Farmers/Consumers 
      Problem StatementFederal Inspector of Drugs, Karachi alongwith FIA conducted a raid at premises of M/s Bismillah Medical Store, District Malir, Karachi and the following unregistered products/Stock was seized from the premises as per Form-2 under Section 18(1) of Drugs Act, 1976.
      Product nameBatch/Lot No.Manufacturer Name
      (as per label)       		Mfg. dateExp. date
      Boostin Injection
      (Recombinant Bovine Somatropin)

      Reg. No. Nil      		BSS22100M/s LG Chem, Korea.   30-05-202329-05-2026
      Threat to Public HealthRecombinant Bovine Somatotropin hormone is 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 market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered 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 Products; Recall of 04 Substandard Batches from the Market

      Asad Ullah Recall Alerts

      Recall Alert

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      DRAP Alert NoNo I/S/10-24-39
      Action Date25th October 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) Punjab has informed DRAP that samples of the following products have been identified as contaminated with DEG/EG impurities based on analysis conducted by the Drug Testing Laboratories Punjab.
      The Details of affected product batches are tabulated below      :-

      Therapeutic Good(s) Affected: –

      S#Product NameCompositionBatch No.Manufactured byTest Results  
      01Zonid Suspension 120ml Reg# 022579Metronidazole 200mg/5mlZ266M/s. Bloom Pharmaceuticals (Pvt.) Ltd., Hattar.Contains Ethylene Glycol Above Permissible limits  
      02Hedazol Suspension 60ml Reg# 046146Metronidazole 200mg/5ml7037M/s. Heal Pharmaceuticals (Pvt.) Ltd., Peshawar.-do-
      03Vometol Suspension 120ml Reg# 094719Domperidone 5mg/5ml1347M/s. Roryan Pharmceutical Industries (Pvt.) Ltd., Peshawar.-do-
      04Tritadin Syrup 60ml Reg# 096413Loratadine 1mg/ml005M/s. Trillium Pharmaceuticals (Pvt.) Ltd., Faisalabad.-do-
      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 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 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.

        Provincial Workshop – Implementation of IDPs for Cross-Cutting Regulatory Functions to Strengthen National Regulatory System of Pakistan held on 21-22 October, 2024 at Lahore

        Asad Ullah Events
        Provincial Workshop – Implementation of IDPs for Cross-Cutting Regulatory Functions to Strengthen National Regulatory System of Pakistan held on 21-22 October, 2024 at Lahore

        Lahore – October 21-22, 2024: The Drug Regulatory Authority of Pakistan (DRAP), in collaboration with the World Health Organization (WHO) Pakistan, hosted a provincial workshop on the implementation of Institutional Developmental Plans (IDPs) aimed at strengthening the National Regulatory System of Pakistan based on WHO recommendations.

        Mr. Nadeem Mahbub, Federal Secretary of the Ministry of National Health Services, Regulation & Coordination, and Ms. Ellen Mpangananji Thom, Officer Incharge, WHO Office in Pakistan participated in this workshop.

        Mr. Asim Rauf, CEO DRAP briefed the participants on the roadmap for strengthening the regulatory system of Pakistan.

        This interprovincial coordination workshop was attended by key officials, including the Director General of Provincial Drug Control Administrations, the Chief Inspector of Drugs from all federating units, Directors of National Quality Control Laboratories (CDL and DTLs), officers from provincial regulatory institutions, and teams from DRAP working on the implementation of the Institutional Developmental Plans (IDPs) based on the WHO Global Benchmarking Tool for National Regulatory Authorities.

        This 02-day workshop provided the opportunities to strengthen the regulatory framework in all federating units by developing collaborative working procedures in various areas including pharmacovigilance, Market Surveillance, Licensing, Inspection, Laboratory Testing and Quality Management System.