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Rapid Alert: Falsified Sildenafil Citrate 100mg Tablets identified in the market

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Rapid Alert

Falsified and Unregistered Sildenafil Citrate 100mg Tablets

DRAP Alert NoNoI/S/02-23-18
Action Date3rd May 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores
3. General Public
Problem StatementFederal Inspector of Drugs Karachi seized a sample of an unregistered product “Viagra 100mg Tablet” from the market and also sent the samples to Central Drug Laboratory, Karachi for testing/analysis. Federal Government Analyst has declared the sample as Spurious under section 3(z-b) (i) of the Drugs Act 1976.

The product detail as mentioned on the label is as under: –

Therapeutic Goods Affected:-

SrProduct NameComposition as per labelBatch #Manufactured by (as stated on label)
1Viagra 100mg Tablets

Mfg. Date: 03-2021
Exp. date:  03-2025		Sildenafil Citrate19990544AGMs. Brooklyn, Ne.
* Tablet Viagra sold in the black market is not registered with DRAP, hence considered Spurious /Falsified and unregistered, and its Quality, Safety, and Efficacy are not ascertained, hence its consumption may be harmful.
Risk Statement:Consequences of the use of unregistered, Spurious/ Falsified Drugs include but are not limited to the followings:
·     Falsified/Spurious drugs may contain toxic ingredients which are manufactured under unhygienic conditions without the proper inspection and approval of the product, which are highly injurious to human health.
·     Poor-quality medicines compromise the treatment of diseases and may intensify the existing condition.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. 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, and information related to the supplier of such products 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 within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products.

-Adverse reactions or quality problems experienced with the use of these product 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 this product 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.

Recall Alert: Drug Product; Spadix Injection (Batch# 570) by M/s. Tabros Pharma Karachi

Asad Ullah Recall Alerts , , , ,

Recall Alert

DRAP Alert NoNoI/S/20-23-21
Action Date20th April 2023
Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Spadix 4mL Injection
Composition: Phloroglucinol and Trimethylphloroglucinol
Manufactured by: M/s. Tabros Pharma, (Pvt) Ltd., Karachi
Batch No. 570
Problem / Issue A video is circulating on social media regarding presence of a fly/insect in a liquid injection ampoule visible with naked eye, apparently seems to be having adulterated quality. The matter is still under investigation, however as a precautionary measure, to prevent any public health hazard, the alleged drug is being recalled from market.
Risk StatementDrug Product contains fly/insect is of adulterated quality which may compromise the standard quality of drugs as not being sterile. The sterility is a basic quality attribute of all Injectable drugs. In this case such adulterated drug may initiate but not limited to following reaction in patients/users
(i) Anaphylactic shock in patients which may lead to death of patient
(ii) Skin rashes, itching, difficulty in breathing
(iii) Sub optimal to no therapeutic effect for indicated medical treatment.
Action Initiated-The manufacturing company / registration holder has been directed to immediately recall the defected 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 quarantine and return to the supplier / company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

-Adverse reactions or quality problems experienced with the use of this product may 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 Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

-All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
    Recall-of-Spadix-InjectinDownload

    Stakeholders Comments are invited on the Draft Guidelines for Good Cold Chain Management Practices for Temperature-Sensitive Drug Products

    Asad Ullah Drugs, General , , ,

    The supply chain of Time and Temperature Sensitive Drug Products (TTSDPs) requires constant maintenance of temperature so that the cold chain remains integral to ensure that the product quality is not compromised. Registration holders of TTSDPs including manufacturers, Importers and exporters along with their authorized distributors, are required to provide suitable storage conditions throughout the life cycle of the product under the Drugs (Licensing, Registering & Advertising) Rules, 1976. Similarly, Pharmacies, Medical stores and other authorized sale outlets, and healthcare institutions are also required to provide suitable storage and distribution while dispensing TTSDPs under relevant provincial drug sale rules.

    DRAP has drafted this guidelines to set out the principal requirements for the safe storage and distribution of time- and temperature-sensitive pharmaceutical products (TTSDPs). These guidelines intended to emphasize the increased importance of pharmaceutical cold chain management as a result of changing product environment, the requirements for Good Storage and Distribution Practices, current regulatory trends, quality management, risk assessment factors, and temperature monitoring system.

    This draft guideline is uploaded on the official website of DRAP dated on 27th March, 2023, for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at akbar.ali∂dra.gov.pk, or can be posted at mailing address, Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

    Draft_Guidance_on_Cold_Chain_Practices_FormattedDownload

    Rapid Alert: Urgent Recall of Suspected Products for Contamination of DEG / EG

    Asad Ullah Product Recalls, Recall Alerts, Safety Info , , , , , , ,

    Rapid Alert

    Urgent Recall of Suspected Product for contamination of DEG / EG

    DRAP Alert NoNoI/S/02-23-8
    Action Date20th February 2023
    Target Audience1. Regulatory Field Force
    2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions
    4. General Public
    Problem StatementMedical Control Agency, Gambia has issued a Safety Alert Ref: – MCA/AD/23/MJK(029) dated 13th February,2023 for KOF Relief Syrup bearing Batch# L394, manufactured by M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan due to presence of Ethylene Glycol (EG) at unacceptable levels. DRAP Inspectorate has initiated the investigation based on this information, and decided to recall all the suspected products manufactured by the firm using the same source of excipient i.e Glycerin and Propylene Glycol (PG).

    The details of suspected contaminated products are as under: –

    Therapeutic Goods Affected:-

    SrProduct NameCompositionBatch #Manufactured by (as stated on label)
    1Bromgen Syp 100mL

    (Reg. Export Only)    		Bromhexine HClL392M/s Davis Pharmaceutical Laboratories,
    Islamabad-Pakistan
    2Kof Relief Syp 100mL
     
    (Reg, Export Only)    		Chlorpheniramine Maleate
    Ammonium Chloride
    Sodium Citrate
    Menthol
    Green Banana Flavour    		L394-do-
    3Macofen Syp 100mL
     
    (Reg, Export Only)    		IbuprofenL395-do-
    4Vomitil Suspension 120mL

    (Reg, Export Only)    		DomperidoneL400, L408,
    L414,    		-do-
    5Asperfin Syp 60mLKetotifenL401-do
    6Davis Tonic Syrup
    (250mL, 120ml)    		Vitamin B12
    Vitamin B1 HCl
    Vitamin B2
    Vitamin B6
    Vitamin B3
    Folic Acid
    Vitamin B5
    Sodium Glycerophosphate
    Manganese Sulphate
    Ferric Ammonium Citrate    		CS07, CS20,
    CS21, CS23,
    CS30, CS31,
    CS42, CS70,
    CS71, CS159    		-do-
    7Zinc Syp 60mLZinc Sulphate MonohydrateCS06, CS36,
    CS37, CS38,
    CS39, CS45,
    CS46, CS47,
    CS48, CS60,
    CS75, CS76,
    CS80, CS81,
    CS83, CS92,
    CS93    		-do-
    Action InitiatedThe manufacturing company has been directed to immediately recall the suspected batches of these products from the market. All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying these batches of products. The remaining stock should be quarantine and return to the supplier / company. Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
    Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products.

    -Adverse reactions or quality problems experienced with the use of these product 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 Consumers-Consumers should STOP using these products and shall contact to 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 Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

    -All therapeutic goods must be obtained from the 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.
    Davis-Rapid-Alert-of-Suspected-Contaminated-ProductsDownload

    Stakeholders Comments are invited on the Draft Guidelines on Good Manufacturing Practices (GMP)

    Asad Ullah Publications, Regulatory Updates , ,

    Although the Drugs (Licensing, Registering & Advertising) Rules, 1976 under the Drugs Act, 1976 provides detail requirements on Good Manufacturing Practices (GMP), however, DRAP intends to provide a compiled GMP guidance document stipulating Drug Regulatory Authority of Pakistan’s (DRAP) expectations on GMP from pharmaceutical & biological drugs manufacturers.

    This document is intended to provide guidance regarding Good Manufacturing Practices (GMP) for the manufacturing of pharmaceutical & biological drug in accordance with the Drugs (Licensing, Registering & Advertising) Rules, 1976, under the Drugs Act, 1976, the good manufacturing practices aim at ensuring that:

    1. Products are consistently produced and controlled to the quality standards appropriate to their intended use
    2. Products are manufactured as required by the marketing authorization or product specification; and
    3. All those risks have been diminished that are inherent in any pharmaceutical / biological production operation, including contamination, cross contamination and mix ups (confusion) that cannot be detected completely through the testing of final products.

    This draft guideline is uploaded on the official website of DRAP dated 5th January, 2023 seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to ajmal.sohail∂dra.gov.pk, copying at hasan.afzaal∂dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

    GOOD-MANUFACTURING-PRACTICE-QMSDownload

    Voluntary Recall Alert: Drug Product; Meronem 1g Injection (Batch #4A20B27 and Batch # 4A21D29) by M/S. Pfizer Pakistan Limited, Karachi

    Asad Ullah Recall Alerts

    Voluntary Recall Alert

    DRAP Alert NoN0 I/V/ 15-22-05
    Action Date18th May, 2022
    Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    2. Healthcare Processionals- Physicians, Pharmacists and Nurses at hospitals and clinics
    3. General Public
    Products Affected Meronem 1g Injection (Intravenous) ,
    Batch No. 4A20B27, Expiry Date: August-2022
    4A21D29, Expiry Date: December-2023
    Problem StatementM/s. Pfizer Pakistan Limited, Karachi has confirmed from their own sources that there is counterfeit Meronem 1gm Injection bearing Batch No. 4A20B27 and 4A21D29, in the market with similar packaging and appearance of their registered product. Due to this, M/s Pfizer Pakistan Limited has initiated a nation wide voluntary recall of 02 batches of their registered product of same batch numbers from the market up to pharmacies and distribution level. Company may be contacted at M/s Pfizer Pakistan Limited, B-2, S.I.T.E, Karachi-75700, Ph +92 (21) 32570621-5
    Action to be takenAll Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batches of Meronem 1g injections to the firm, company is also communicating distributors through this letter. Distributors and pharmacies are advised to be vigilant and report any suspected product(s) to the DRAP. Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance to ensure the integrity of supply chain.
    Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

    If anyone has used this counterfeit product, or if anyone suffer an adverse reaction/event having used this product batch, it is advised to seek immediate medical advice from a qualified healthcare professional, and to report the incident to Drug Regulatory Authority of Pakistan/National Pharmacovigilance Centre using this link.

    All drug products must be obtained from authorized licensed sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.
    Meronem-1gm-inj-Recall-Alert-dated-18-05-22Download

    DRAP invites comments of stakeholders on the draft Guidelines on Good Distribution Practices for Pharmaceutical and Biological Products

    Ijaz Mustafa Drugs, Publications, Regulatory Updates ,

    Distribution of drug products includes all activities consisting of procuring, storage / holding, supplying, importing, and / or exporting of products. Such activities are carried out by the marketing authorization /registration holder including manufacturers/importers or their authorized distributors, which supply products to the pharmacies/licensed drug sale outlets and healthcare institutions which are entitled to dispense drug products.

    Good Distribution Practice (GDP) is the set of standards of quality assurance for sourcing, handling, storage, and transportation of pharmaceutical and biological drug products under appropriate conditions, as required by the marketing authorization (MA) / registrant, or product specifications. To maintain the quality of pharmaceutical and biological products, every activity in the supply chain and distribution network should be carried out according to the principles of Good Distribution and Storage Practices.

    These guidelines are drafted to provide appropriate systems and structures to assist manufacturers, distributors and wholesalers in fulfilling their responsibilities of planning and conducting various activities in the distribution and supply chain, which will be helpful in prevention of proliferation of unauthorized/unregistered, substandard and falsified products in the market.

    This draft guideline is uploaded on the official website of DRAP dated 28th May, 2022, for seeking comments and suggestions from stakeholders on the draft document. 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 ajmal.sohail∂dra.gov.pk, copying at akbar.ali∂dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

    Please click to view the draft Guidelines-on-Good-Distribution-PracticesDownload

    Stakeholder Comments are invited on draft guidance for Categorization of deficiencies in Good Manufacturing Practices (GMP)

    Ijaz Mustafa Drugs ,

    Drug Regulatory Authority of Pakistan (DRAP) aims at providing a comprehensive guidance to the inspectors for categorizing the GMP non-compliances found during inspections. This document is intended to inform stakeholders regarding the principles used to classify GMP deficiencies and provide examples of the classification of different types of deficiencies.

    The key objectives of categorizing the GMP non-compliances during report writing are:-

    The harmonization of the classification of GMP deficiencies to facilitate synchronized reporting of GMP deficiencies from inspections across the inspectorate. Harmonization will help ensure that there is a consistent view across the inspectorate of what constitutes a “Critical” deficiency and what constitutes a “Major” deficiency. Risk management principles will be applied to the categorization of these deficiencies dependent on the type of product manufactured or process.

    This guidance document is also intended to:

    1. provide actions to be taken by inspectorates in response to the reporting of critical and major deficiencies;
    2. enhance communication, information sharing and scientific exchange to promote increased consistency and predictability in regulatory
    3. to provide a tool to support the risk-based classification of GMP deficiencies from inspections and to establish consistency amongst Inspectorates.

    This guidance will enable Industry to be informed of the principles used to classify GMP deficiencies and also provide examples of the classification of
    different types of deficiencies. Notwithstanding, this approach is not binding as the classification takes also into account the context of the finding and the quality history of the site. It does not remove the responsibility of the company in assessing the impact of he finding on the products already on the market and/or on their quality system.

    Consistency of classification of GMP deficiencies will assist in the following:

    1. Improve consistency in reporting and facilitate communication between inspectors;
    2. Harmonize inspectorate response and management of deficiencies classified as “Critical”, “Major” and “Other”;
    3. Provide transparency in how the deficiencies are classified; and
    4. Simplify deficiency trend analysis based on harm

    This draft guideline is uploaded on the official website of DRAP dated 28th May, 2022, for seeking comments and suggestions from stakeholders on the draft document. 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 ajmal.sohail∂dra.gov.pk, copying at hasan.afzaal∂dra.gov.pk , or can be posted at mailing address, Additional Director, Quality Assurance & Lab Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

    Please click to view the Draft Guidance on categorization of deficiencies in GMPDownload

    DRAP issues final Guidance document for applicants on Import and Export permissions of therapeutic goods in the country

    Asad Ullah News & Updates, Publications, Regulatory Updates

    DRAP has a regulatory oversight on import and export of all type of therapeutic goods to determine whether they are permittable in accordance with the applicable drug laws, and refuses the entry or exit of any therapeutic good in case of noncompliance to the regulatory requirements.

    “Import and export of any therapeutic goods prohibited under Rule 23 of the Drugs Act 1976 and Schedule II of the DRAP Act 2012 are punishable under Rule 27 of the Drugs Act 1976 and Schedule III of the DRAP Act, 2012”

    These regulatory controls are applied to prevent the infiltration of substandard and suspected falsified medicine into the supply system and to assure the access to standard quality therapeutic goods. This guidance document will elaborate the requirements, procedures for imports and exports for any therapeutic good e.g. finished pharmaceutical and biological drug products, active pharmaceutical ingredients (APIs) and drug substances (DS), Medical Devices, and Health & OTC Product (e.g. nutraceuticals, herbals, ayurvedic and homeopathic products, biochemic and Chinese products) and their raw materials. It covers the both import and export of therapeutic goods for commercial and non-commercial purposes, and also provides guidance on determination of the eligibility of importers and exporters.

    Please click to access the final guidance document on “Import and Export of Therapeutic Goods“

    The main objective of these guidelines is to provide legal and regulatory requirements to importers and exporters of therapeutic goods, enabling them to comply with the applicable drug laws for import and export of therapeutic goods. These guidelines specify the format and content of the relevant applications and procedures to receive necessary authorizations or permissions by DRAP.

    For more information on regulatory guidelines issued by DRAP, please navigate to our section on “Regulatory Guidelines“