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Recall Alert: Drug Product; Famila 150mg Injection (Batch # 083) By Zafa Pharmaceutical Laboratories, Karachi

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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

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      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.

      Minutes of 340th meeting of Registration Board held on 1st – 2nd October, 2024

      Asad Ullah Meeting Minutes, Registration Board

      The Drug Registration Board convened 340th meeting on October 1 – 2, 2024, in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.

      Minutes of 340th meeting of Registration Board (1)Download

      Submission of Replies against Deferred Form-5/5A Applications of Human Drugs

      Ijaz Mustafa General

      In its 339th Meeting, convened from August 6-8, 2024, the Registration Board has issued a directive that all applicants should submit clarifications or replies for their deferred Form-5/5A applications by December 31, 2024. It is imperative to note that any submissions received after this deadline will not be considered, and will be be classified as disposed of, necessitating the submission of a new application on Form 5F.

      This initiative is designed to enhance the efficiency of the registration process and ensure strict adherence to current regulatory standards. This directive is in accordance with the implementation of the Form 5F (CTD) format for drug registration, effective March 31, 2019, which requires that all applications be evaluated based on the updated Form 5F data guidelines.

      submission-of-replyDownload