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Author: Asad Ullah

DRAP finalized the 2nd Edition of Guidelines on Post-Registration Variation of Drug Products

Asad Ullah Drugs

DRAP has finalized the second edition of its guidelines on procedure and data requirement for post registration variation of drugs. Registration / Marketing Authorization holders are responsible for the safety, efficacy, and quality of drug products that are placed on the market throughout their approved life cycle.

This guidelines are intended to provide information for submission of post-registration variation application by the registrations / marketing authorization holders of drug products. It includes categories of variations and the required documentation & procedures for submission of an application for a particular variation.

These Guidelines will assist both Regulators and Industry on the regulation of variation / changes to the original registrations / Market Authorization of products in terms of procedures and criteria for the appropriate categorization, reporting of changes and subsequent approval as required. Data requirements are listed out to evaluate the impact of the proposed / intended change on the quality, safety and efficacy of the locally manufactured / imported finished pharmaceutical and biological drug products intended for human and veterinary use.

These guidelines are intended to provide supportive information for submission of post registration variation application by the registrations / marketing authorization holders of the finished drug products to implement a change. The draft guidelines were uploaded on the website in July 2023 seeking comments of stakeholders on the contents of document.

The Guidelines have been finalized keeping in view the comments and suggestions of the Stakeholders. Please navigate to the Publications on the DRAP website for latest guidelines by DRAP.

Post Registration Variation Guidelines (Edition 02)Download

Decisions of 60th 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 its 60th meeting has deferred the following applications of registration 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.

Deferred-letters-MDB-60Download

Rapid Alert; Drug Product: Unregistered and Falsified Immune globulin Products (Hyp-Rho-D and RhoColne Injections)

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Rapid Alert

DRAP Alert NoNo  I/S/09-23-35
Action DateSeptember 22, 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 and clinics etc.
4. General Public
Problem StatementThe Regulatory field force has Identified two spurious brands of Anti-D immunoglobulin injections in the market which are not legally imported into Pakistan.

The identified brands include Hyp-Rho-D purported to be manufactured by M/s. Woolmar Chemical Corporation USA and distributed by M/s. Zaryab Traders Lahore, and Rhocolone® 300 mcg purported to be manufactured by M/s. Bharat Serums and Vaccines Limited, India.

The manufacturer and stated distributor of Hyp-Rho-D injection is unknown and has no legal status in the supply chain of drugs.

Secondly, the authorized distributor of M/s. Bharat Serums and Vaccines Limited India i.e. M/s. Hakimsons (impex) (Private) Ltd., Karachi have informed us that their principal company has not supplied any batch of product Rhocolne 300mcg to Pakistan.

The product details are as under: –

Therapeutic Goods Affected:-

SrProduct NameCompositionBatch #Mfg. DateExp. DateManufactured by
(as stated on the label)
1Hyp-Rho-D Injection
 
Registration No: Nil
Rho (D) immunoglobulin (Human) for injection09181943—Jan-2025M/s. Woolmar Chemical Corporation, USA.

Importer / Distributor:
Ms. Zaryab Traders Lahore.
2Rhocolne 300mcg Injection

Registration No: Nil		Rho (D) immunoglobulin (Human) for injection39VAN006505.11.202205.11.2022Bharat Serums & Vaccines Limited, India.
Fig.1. Images of Falsified Hyp-Rho D Injection
Fig. 2. Images of Falsified Rhoclone Injection
Risk Statement:The product claimed to contain immune globulin (anti-D immune globulin or RhIG), which is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Both of these products are unregistered which infers that the quality and safety attributes of the product are not accepted and approved by DRAP. Unregistered Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the product are unknown.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate these products. 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 products.

-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.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using these products 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; Pedolil 250mg/5mL Suspension (Batch # 167) by M/S. JASM Pharmaceutical (Pvt.) Ltd., Risalpur.

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo II/S/08-23-32
Action Date18th Sep, 2023
Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
· Procurement Officers at Hospitals and Healthcare Institutions.
· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Pedolil 250mg/5mL
Suspension
 
Reg No. 110389		Paracetamol
(Acetaminophen)		Batch No 167
 
Mfg. date 05.2023
Exp. date 04.2025		Ms. JASM Pharmaceutical
(Pvt.) Ltd., Risalpur
Risk Statement:Paracetamol suspension is used for mild to moderate pain and fever. Inaccurate use of the product may lead to adverse reactions including but not limited to following:
·         Blood disorders, such as thrombocytopenia and leukopenia.
·         Liver and kidney damage.
Impact of use of substandard product on basis of deliverable volume may leads to non- uniformity of dose and may alter therapeutic effect.
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 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) 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 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; Comycetin 0.5% Eye Drops (Batch # CYF003) by M/S. Nabiqasim Industries (Pvt) Ltd., Karachi

    Asad Ullah Recall Alerts

    Recall Alert

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    DRAP Alert NoNo II/S/08-23-33
    Action Date18th Sep, 2023
    Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
    · Procurement Officers at Hospitals and Healthcare Institutions.
    · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
    Problem / Issue

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch No Manufacturer
    Comycetin 0.5% Eye Drop
     
    Reg No. 003682

    		ChloramphenicolBatch No CYF003
     
    Mfg date 02.2023
    Exp date 02.2025    		Ms. Nabiqasim Industries
    (Pvt.) Ltd., Karachi
    Risk Statement:Chloramphenicol is used to treat bacterial eye infections. The impact of use of the substandard product may lead to sub-optimal to no therapeutic effect and may intensify/flare the existing bacterial infection along with the development of Bacterial resistance.
    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 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) 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 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; Kemygyl 200mg/5mL oral Suspension (Batch # M-319) by M/s. Alkemy Pharmaceutical Laboratories (Pvt) Ltd, Hyderabad

      Asad Ullah Recall Alerts

      Recall Alert

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      DRAP Alert NoNo II/S/08-23-31
      Action Date08th Sep, 2023
      Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
      · Procurement Officers at Hospitals and Healthcare Institutions.
      · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
      Problem / Issue The Provincial Government Analyst/Director, Drug Testing Laboratory, Karachi has declared the Batch No. M-319 of Kemygyl Suspension as of substandard quality sampled by Provincial Inspector of Drugs Jamshoro.

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch No Manufacturer
      Kemygyl Suspension 200mg/5ml

      		MetronidazoleBatch No M-3019
       
      Mfg date 09.2022
       
      Exp date 08.2024      		Ms. Alkemy Pharmaceutical Laboratories (Pvt.) Ltd, Hyderabad.
      Risk Statement:Metronidazole Oral Suspension is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or suspected. Use of substandard products may lead to suboptimal to no-therapeutic effects and may contribute to drug resistance, and can also intensify/exacerbate the existing bacterial infection.
      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 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) 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 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.

        Rapid Alert; Drug Product: Falsified Defitelio 80mg/mL Injection identified in Neighboring Countries

        Asad Ullah Recall Alerts
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        Rapid Alert

        Falsified Defitelio 80mg/mL Injection
        (Updated form WHO)

        DRAP Alert NoNo  I/S/09-23-44
        Action DateSeptember 08, 2023
        Target Audience1. Regulatory Field Force.
        2. Healthcare Professionals – Physicians, Pharmacists, and Nurses.
        3. General Public.
        Problem StatementWHO has informed regarding the presence of a falsified batch of DEFITELIO (defibrotide sodium) Lot No. 20G20A detected in India (April 2023) and Türkiye (July 2023) and was supplied outside of regulated and authorized channels. This product is not registered in Pakistan however, due to its detection in the neighboring countries, it is highly likely that this product can infiltrate the Pakistani market.
        DEFITELIO (defibrotide) is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in hematopoietic stem-cell transplantation (HSCT) therapy. It is indicated for adults, adolescents, children and infants over 1 month of age. VOD is a condition in which the veins in the liver become blocked and stops the liver from working correctly.
        The genuine manufacturer of DEFITELIO has confirmed that the product referenced in this Alert is falsified. The genuine manufacturer has advised that:
        ·         Genuine DEFITELIO with Lot 20G20A was packaged in German/Austrian packaging.
        ·         The falsified products instead are in UK/Ireland packaging.
        ·         The stated expiry date is falsified and does not comply with the registered shelf life.
        ·         The stated serial number is not associated with batch 20G20A.
        ·         DEFITELIO does not have marketing authorization in India and Türkiye.

        Therapeutic Goods Affected:-

        SrProduct NameCompositionBatch/Lot #Mfg. DateExp. DateManufactured by
        (as stated on label)
        1DEFITELIO 80 mg/mL concentrate for solution for infusion
        		Defibrotide20G20A—Aug-2024Gentium Srl
        (UK/ Ireland packaging)
        Threats to Public HealthThe use of falsified DEFITELIO will result in the ineffective treatment of patients and may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances. Moreover, the safety, sterility, and quality of the falsified products referenced in this alert are also unknown.
        Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. Since this product is not registered with DRAP, it is not permitted to be stocked or sold in pharmacies or other retail outlets. However, it is crucial for all healthcare professionals, including pharmacists and chemists, to check their stock immediately and stop the distribution or supply of this product if it is found. Information related to the supplier of this product 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 the above-mentioned products.

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

        Pictures of Defiiteli 80mg/mL injection identified as falsified Product

        Pictures of Falsified Defitelio 80mg/mL Injection identified in Türkiye

        Recall Alert: Drug Product; Plivil 25mg Injection (Batch # 847) by M/s. Pliva Pakistan, (Pvt) Ltd, Baluchistan

        Asad Ullah Recall Alerts

        Recall Alert

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        DRAP Alert NoNo I/S/08-23-22
        Action Date06th Sep, 2023
        Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
        · Procurement Officers at Hospitals and Healthcare Institutions.
        · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
        Problem / Issue The Secretary, PQCB Baluchistan has informed DRAP that samples of Plivil Injection (Batch No. 847) manufactured by M/s. Pliva Pakistan (Pvt.) Ltd., B-77, Lasbella Industrial Estate, Baluchistan, has been analyzed by the Government Analyst, Drug Testing Laboratory (DTL), Baluchistan, Quetta and declared as Adulterated and misbranded based on analysis.

        Therapeutic Goods Affected:-

        Product NamesCompositionBatch No Manufacturer
        Plivil 25mg/ml Injection

        Reg No 021513        		Pheniramine Maleate
        25mg/ml        		Batch No 847
         
        Mfg date 02.2023
         
        Exp date 02.2025        		M/s. Pliva Pakistan (Pvt.) Ltd., Baluchistan.
        Risk Statement:Presence of foreign particles may interact within the injectable solution and may change the chemical consistency of the solution. If injected, they can cause inflammation, tissue damage, or allergic or immunogenic reactions. Additionally, unclear labels on the drug products may create difficulty in reading and understanding of drugs and may lead to medication errors such as taking the wrong medication or the wrong dose.
        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 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) 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 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 59th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

          Asad Ullah Medical Devices Board

          The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 59th meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.

          Defered-Letter-of-59th-Meeting-of-MDBDownload