Drug Regulatory Authority of Pakistan, Ministry of National Health Services, Regulations Á Coordination, Islamabad

Note: â€œComments/input within 15 days is requested from relevant stakeholders in use of antimicrobials including healthcare delivery organizations, healthcare professionals and healthcare professional councils i.e. Pakistan Medical Commission Council, Pakistan Pharmacy Council and Nursing Council, Pharma Bureau, Pakistan Pharmaceutical Manufacturers Association (PPMA) etcâ€

Deficiency letter of all deferred products in 81st meeting of EEC held on 25-8-2020

Notice for Importers / Pharmaceutical Companies for creation of user accounts on PIRIMS

All the importers /Pharmaceuticals Companies are advised to create login registrations at PIRIMS up to 30th November 2020, Your provisional username and passwords will be issued after the registration process in PIRIMS Software.

User Manual of PIRIMS for pharmaceutical companies

DEADLINE FOR THE CREATION OF PHARMACEUTICAL COMPANIES USER ACCOUNTS ON PIRIMS SOFTWARE

Message of CEO DRAP on World Antimicrobial Awareness Week.

Minutes of 296th Meeting of Registration Board

PREVENTATIVE MEASURES FOR COVID-19 IN DRAP

Circular

List of Approved BA/BE Studies Center under the Bio-Study Rules 2017

List of Approved BA/BE Studies under the Bio-Study Rules 2017

List of Approved Bio-Analytical Lab under the Bio-Study Rules 2017

List of Approved Clinical Trials/Studies Under the Bio-Study Rules 2017

List of Approved Contract Research Organizations (CROs) Under the Bio-Study Rules 2017

List of Approved Clinical Trial Sites Under the Bio-Study Rules 2017

Launch of Med Safety Mobile App

REACHING OUT TO PUBLIC THROUGH HOLDING OF E-KACHEHRI

SRO.1100(I)/2020

SRO.1096(I)/2020

TENDER DOCUMENTS FOR SUPPLY OF Mobile Tablets

TENDER DOCUMENTS FOR SUPPLY/ INSTALLATION OF PHOTOCOPIERS

GUIDANCE DOCUMENT FOR SUBMISSION OF APPLICATION ON FORM 5-F (CTD) FOR REGISTRATION OF PHARMACEUTICAL DRUG PRODUCTS FOR HUMAN USE. [12 OCT, 2020]

SRO-967(I)2020 [05 OCT, 2020]

DRAFT GUIDE LINES FOR COMPLAINT HANDLING [06 OCT, 2020]

FAST TRACK REGISTRATION OF FLUDROCORTISONE [15 Sep, 2020]

Online Hands On Training of Pakistan Integrated Regulatory Information Management System(PIRIMS) [10 Sep, 2020]

Reaching Out to public through holding of E kachehri [09 Sep, 2020]

Registration of Potassium Iodide tablet as registered drug [03 Sep, 2020]

Tender for Stationery Item 2020-21, DRAP [02 Sep, 2020]

Notification for Designated official under right of access to information Act,2017(XXXIV) [25 Aug, 2020]

Deficiency letter of all deferred products in 80th meeting of EEC held on 26-6-2020- Part-2.pdf [24 Aug, 2020]

Deficiency letter of all deferred products in 80th meeting of EEC held on 26-6-2020 [19 Aug, 2020]

National Essential Medicines List 2020 [12 Aug, 2020]

Minutes of 295^th meeting of Registration Board held on 8^th to 11^th June, 2020 [07 Aug, 2020]

Minutes of 79^th Meeting of EEC held on 14^th May, 2020 [06 Aug, 2020]

Minutes of 78^th Meeting of EEC held on 23^rd April, 2020 [06 Aug, 2020]

Minutes of the 17^th Meeting of the Medical Device Board (MDB) held on 13^th July, 2020 [30 Jul, 2020]

Voluntary Recall of Herceptin Solvent Vials-20ml Batch Number: N7396B04 Due to Glass Particles in Solvent Vials [17 Jul, 2020]

Drug Pricing Policy 2018 as Ammenended Vide Notification No.F.11-2/2020-DD(P) Dated: 15 Jul, 2020 [17 Jul, 2020]

Annual Adjustement in MRPS of Drugs under paragraph 7 of Drug Pricing Policy 2018 [17 Jul, 2020]

Priority Approval/Registration of Drugs Favipiravir During the COVID-19 Pandemic [14 Jul, 2020]

Updated Members of Policy Board for Drug Regulatory Authority of Pakistan (DRAP) [10 Jul, 2020]

Provisional List Establishment Licenses issued under MDR, 2017 - Form 3, Form 4, Enlistment Import, Enlistment Local, Registration Import, Registration Local (MDMC Division) [07 Jul, 2020]

Provisional List Form 6 Local Manufacture, Form 6-A (MDMC Division) [07 Jul, 2020]

Provisional List Form 7 Local Manufacture, Form 7-A (MDMC Division) [07 Jul, 2020]

Notification - Labelling Requirements for H&OTC Products [02 Jul, 2020]

Donation of COVID-19 Convalescent Plasma [01 Jul, 2020]

Checklist for No Objection Certificate for import of unregistered/ not available medical device(s) under medical devices rules, 2017 [25 Jun, 2020]

Notification - for maximum retail price (MRP) of Remdesivir [22 Jun, 2020]

Advisory - Use of REMDESIVIR in the current COVID-19 Pandemic [19 Jun, 2020]

Notification for want of information with respect to deferred products in 79th meeting of EEC held on 14 May, 2020 [16 Jun, 2020]

Medical Product Alert - Dopacin Injection (Dopacin HCI) 200mg/5ml Batch No. DP-02 [15 Jun, 2020]

Priority Approval/Registration of Drugs Remdesivir and Tocilizumab During the COVID-19 pandemic [15 Jun, 2020]

Notification F.No.4-2/2017-DD(H&OTC):- Guidelines for export facilitation of H&OTC products [11 Jun, 2020]

Advisory on conduct of clinical trials during COVID-19 pandemic final [04 Jun, 2020]

Safety Alert of falsified and contaminated defibrotide identified in WHO regions [04 Jun, 2020]

Minutes of 294th meeting of Registration Board [25 May, 2020]

Withdraw Notification No. F.No.4-2/2017-DD(H&OTC) dated 6 April 2020 [21 May, 2020]

Circular Priority Approval / Registration of Drugs During the COVID-19 Pandemic [07 May, 2020]

Advisory Recommendations for Interactions with Experimental COVID-19 Therapies [06 May, 2020]

Safety Alert Detection of NDMA in Ranitidine Containing Medicines [06 May, 2020]

Tender Document Supply/ Installation of Procurement of Desktop Computers, MFP Network Printers / Copiers & Mobile Tablet [04 May, 2020]

Tender Document For Biometric Machines, Customized Software & Door Locks [04 May, 2020]

Notification regarding cost recovery mechanism in respect of out-station inspections [30 Apr, 2020]

Circular Priority Approval/Registration of Drugs During the COVID-19 Pandemic [30 Apr, 2020]

Advisory Consideration for Pharmacies and Medical Stores During the COVID-19 [30 Apr, 2020]

Advisory Reminder of Risk of Serious Side Effects with Chloroquine and Hydroxychloroquine During the COVID-19 [30 Apr, 2020]

Medical Product Alert - Mariadin Injection (Ranitidine (as HCl) 50mg/2ml) [30 Apr, 2020]

Medical Product Alert - Nexalite Injection (Tranexamic Acid 250mg/5ml) [30 Apr, 2020]

Advisory on Reporting of Pharmacovigilance Data During COVID-19 Pandemic [27 Apr, 2020]

Manufacturing and Sale of Substandard Drug Paracetamol Tablet B.N0.10-M/S Ahson Drugs Company, Tando Adam Descision of 293rd Meeting of Registration Board [23 Apr, 2020]

Guidelines for Enlistment of Homeopathic Combinations [21 Apr, 2020]

Letter of cases of sanitizers Permitted in 77th meeting of EEC held on 15th April, 2020 [18 Apr, 2020]

Letter of cases of sanitizers Rejected in 77th meeting of EEC held on 15th April, 2020 [18 Apr, 2020]

Letter of cases of sanitizers Deferred in 77th meeting of EEC held on 15th April, 2020 [18 Apr, 2020]

Advisory to Protect/ Support Pharmacists on the Coronavirus (COVID-19) Frontline [16 Apr, 2020]

Fee for Issuance of GMP Certificate for Local Manufacturing and Export Purposes [16 Apr, 2020]

Safety Alert of Falsified Chloroquine Products Circulating in the WHO Region of Africa [15 Apr, 2020]

Letter of cases of sanitizers permitted in 76th meeting of EEC held on 10th April, 2020 [14 Apr, 2020]

Letter of cases of sanitizers rejected in 76th meeting of EEC held on 10th April, 2020 [14 Apr, 2020]

Letter of cases of sanitizers deferred in 76th meeting of EEC held on 10th April, 2020 [14 Apr, 2020]

Safety Alert of Falsified Medical Products, including In Vitro Diagnostics, that claim to Prevent, Detect, Treat or Cure COVID-19 [14 Apr, 2020]

[Revised Version] Guidance Document of Technical committee constituted by PEC to prepare Fast Track Acceptance Test Procedure for Locally Developed Mechanical Ventilators [13 Apr, 2020]

Letter of Permission to Prepare Hand Sanitizers [10 Apr, 2020]

Deferred Applications of Hand Sanitizers [10 Apr, 2020]

Rejected Applications of Hand Sanitizers [10 Apr, 2020]

Notification regarding Hand Sanitizer [06 Apr, 2020]

Safety Alert Serious Mental Health Side Effects with Asthma and Allergic Drugs MONTELUKAST [06 Apr, 2020]

Advisory Ensuring prescription based sale of CHLOROQUINE PHOSPHATE containing dosage forms [24 Mar, 2020]

Postponed of opening of auction of old machinery and furniture items [24 Mar, 2020]

Auction Notice - Old Machinery and Furniture Items [18 Mar, 2020]

Advisory - Postponement of Conferences, Seminars, Symposium, Workshops and Other Meeting involving Large Gathering [17 Mar, 2020]

Medical Product Alert
Availability/Sale of Unauthorized stock of potentially counterfeit Prevenar Vial Prevenar PFS Registration No. 066110 Marketed by Wyeth Pakistan Limited. [16 Mar, 2020]

Minutes of 273rd Meeting of Central Licensing Board held on 15th January, 2020 [16 Mar, 2020]

Monthly progress report of Licensing Division for the period from 01-11-2019 to 30-11-2019 [16 Mar, 2020]

Safety Alerts of falsified antimalarials in West and Central Africa displaying an outdated WHO essential drugs programme logo [13 Mar, 2020]

Complaint regarding use of RESTANE (ISOFLURANE) B.NO.NO219d16- Interim Report [03 Mar, 2020]

Visiting hours for Representatives of Pharmaceutical Firms & General Public [27 Feb, 2020]

Minutes of 293 Meeting of Registration Board [21 Feb, 2020]

Establishing Regulatory Pathway of Licensing System: A Progressive Approach
This document has been shared for initial consultation with our stakeholders. Please forward your comments on sultanghani1940@gmail.com by 26th February, 2020 [21 Feb, 2020]

Safety Alert Quality Defect in LPV Vaccine Imported from India [21 Feb, 2020]

Minutes of the 16th meeting of the Medical Device Board (MDB) held on 03-02-2020 [19 Feb, 2020]

Minutes of the 15th meeting of the Medical Device Board (MDB) held on 30-12-2019 [19 Feb, 2020]

Minutes of the 14th meeting of the Medical Device Board (MDB) held on 11-10-2019 [19 Feb, 2020]

Minutes of the 13th meeting of the Medical Device Board (MDB) held on 05-08-2019 [19 Feb, 2020]

Provisional List of Registered & Enlisted Medical Devices for Import [19 Feb, 2020]

Provisional List of Registered & Enlisted Medical Devices for Local Manufacture [19 Feb, 2020]

Advertisement Regarding Ban on Import & Local Manufacturing of Disposible Syringes [19 Feb, 2020]

Provisional List of Establishment License to Import Medical Devices [19 Feb, 2020]

Invitation to bid for Photocopies of Official Documents on need basis - Closing Date: February 20, 2020 [06 Feb, 2020]

Date wise Provisional List of Applications for Provisional Enlistment of Nutraceutical, Herbal/Unani products applied by the firms having both types of sections or import [04 Feb, 2020]

Date wise Provisional List of Application for Provisional Enlistment of Homeopathic products [04 Feb, 2020]

Date wise Provisional List of Applications for Provisional Enlistment of Herbal/Unani products [04 Feb, 2020]

Minutes of 272 meeting of the Central Licensing Board (CLB) [30 Jan, 2020]

Activities in Drug Licensing Division for the month of October, 2019 [30 Jan, 2020]

Draft Amendment in Rule 27 of the Drugs (L,R&A) Rules 1976 for extension in time for renewal of Drug Registration
["Stakeholders may submit their comments to Division of Legal Affairs within fourteen days (by 03-Feb-2020)."] [21 Jan, 2020]

Notification of Members of the Appellate Board [16 Jan, 2020]

Request for Expression of Interest (EOI) for Hiring Individual Consultant [15 Jan, 2020]

S.R.O. 1572(I)/2019 Notification of Drugs Control and Traditional Medicines Division (NIH) appellate laboratory for certain medical devices [13 Jan, 2020]

S.R.O. 1571(I)/2019 Notification of CDL for testing the quality, safety and performance of certain medical devices [13 Jan, 2020]

Guidelines for Manufacturer/Importer of "Food Supplement" or "Dietary Supplement" or "Health supplement" or "Nutraceuticals" as to what is meant by "Alternative Medicine and Health Products Dosage Forms" [13 Jan, 2020]

Costing and Pricing S.R.O 09(I)/2020 [07 Jan, 2020]

Draft Amendments in the Drugs (L,R&A) Rules, 1976 for Test and Analysis of Drugs on Contract
["Stakeholders may submit their comments to Division of Licensing within fifteen days (i.e: 18-Jan-2020)."] [03 Jan, 2020]

Costing and Pricing S.R.O 913(1)/2017 [03 Jan, 2020]

Tender documents supply/ installation of hardware (server, scanners & barcode printers) [27th Dec, 2019]

S.R.O. 1460(I)/2019 Amendments in the Drugs (Licensing, Registration and Advertising) Rules, 1976 [29th Nov, 2019]

Minutes of 292 Meeting of Registration Board - Held on 1st-2nd October, 2019 [21th Nov, 2019]

List of valid Drug Manufacturing Units operating in Pakistan [15th Nov, 2019]

Guidelines for the Conduct of Clinical Trial - 1st Edition [14th Nov, 2019]

List of renewal application of year 2018 approved by Registration Board [13th Nov, 2019]

List of renewal application of year 2018 deferred by Registration Board for the rectification of shortcomings [13th Nov, 2019]

Invitation to Bid (For Photocopies of Documents/Old Record) [11th Nov, 2019]

Alert Of Falsified Quinine Bisulphate: Circulating In Uganda And Quinine Sulphate Circulating In Central African Republic And Chad [8th Nov, 2019]

Draft Guideline for PRIORITY REVIEW AND ACCELERATED APPROVAL OF REGISTRATION / MARKET AUTHORIZATION (1st Edition)
["Stakeholders may submit their comments to Division of PE&R within fifteen days (till date: 15-Nov-2019) on the following email address: addl-dir.pe.reg@dra.gov.pk"] [07th Nov, 2019]

List of Federal Inspector of Drugs [04th Oct,2019]

CTD- Pre Submission Screening Checklist [29th Sep,2019]

Training Manual of IRIMS [1st Aug,2019]

Training of Drug-Integrated Regulatory Information Management System (D-IRIMS) for Pharmaceutical Industry [11th July,2019]

Regulatory Information

Drug Regulatory Authority of Pakistan Act, 2012
Drugs Act, 1976
SROs
The Drugs (Labelling and Packing) Rules, 1986
The Drugs (Licensing, Registering & Advertising) Rules, 1976
The Drugs (Appellate Board) Rules, 1976
The Drugs (Research) Rules, 1978
The Drugs (Federal Inspectors, Federal Drug Laboratory & Federal Government Analysts) Rules, 1976
The Drugs (Imports & Exports) Rules, 1976
The Drugs (Specifications) Rules, 1978
The Northern Areas Drugs Rules
Alternative Medicines & Health Products (Enlistment) Rules 2014

Recall Alerts

Medical Product Alert

SUBSTANDARD DELMOL SUSPENSION BATCH NO.151 MFG DATE 05-2021, EXP DATE 05-2023 MANUFACTURED BY M/S DELTA PHARMA (PVT) LTD NOWSHERA

Medical Product Alert

SUBSTANDARD NYLOZ CAPSULE BATCH NO. C01358 MANUFACTURED BY M/s ZEPHYR PHARMATEC, KARACHI

Medical Product Alert

PRESENCE OF SPURIOUS MERONEM INJECTION, BATCH NO. 4B20E273 PURPOTED TO BE MANUFACTURED BY M/S PFIZER PAKISTAN LIMITED IN THE MARKET

Medical Product Alert-Indobid Capsules

Drug Recall of Sub-Standard Indobid capsules,Reg No.007106,Batch No.386 Manufactured by M/s Adamjee Pharmaceuticals (Pvt),Ltd Karachi.

Medical Product Alert-Parapals Infusion

Drug Recall of adultrated and sub-standard Parapals infusion,Reg. No. 088360. Batch No. LI-052. Manufactured by M/s Inventor Pharma Karachi

Medical Product Alert-Parapals Infusion

Drug recall of adultrated and sub-standard Parapals infusion,Reg.No. 088360. Batch No. LI-051. Manufactured by M/s Inventor Pharma Karachi

Medical Product Alert-Tempramine Suspension

Manufacture & Sale of Sub-Standard Tempramine Suspension. Reg. No.011432 Batch No 5TR057 Manufactured by M/s W.Woodward Pakistan (Pvt.) Ltd.,Karachi.

Medical Product Alert-Tempramine Suspension

Manufacture & Sale of Sub-Standard Tempramine Suspension. Reg. No.011432 Batch No. 5TR131 Manufactured by M/s W.Woodward Pakistan (Pvt.) Ltd.,Karachi.

Medical Product Alert-Tempramine Suspension

Manufacture & Sale of Sub-Standard Tempramine Suspension. Reg. No.011432 Batch No. 5TR052 Manufactured by M/s W.Woodward Pakistan (Pvt.) Ltd.,Karachi.

Medical Product Alert-Tempramine Suspension

Manufacture & Sale of Sub-Standard Tempramine Suspension. Reg. No.011432 Batch No. 5TE049 Manufactured by M/s W.Woodward Pakistan (Pvt.) Ltd.,Karachi

Medical Product Alert-Sterile Water for Injection

Manufacture and sale of Adultrated and Substandard sterile water for injection Reg.No.030217,Batch No. 799 Manufactured by M/s Zafa Pharmaceuticals Laboratories(Pvt).Ltd,Karachi.

Medical Product Alert-Gentamed Injection

Manufacture & Sale of Adulterated & Sub-standard Gentamed Injection Reg No. 053243. Batch No. A-20434 Manufactured by M/s. Mediate Pharmaceutical (Pvt.) Ltd., Karachi.

Medical Product Alert-Maparix Infusion

Manufacture & Sale of Sub-Standard Maparix Infusion. Reg. No. 050695.Batch No. L-21019 Manufactured by M/s S.J.&G. Fazul Ellahie (Pvt.) Ltd.Karachi.

Medical Product Alert-Hitaxime 1gm injection

Manufacture & sale of sub-standard Hitaxime 1gm Injection (vial), Reg.No.044109. Batch No. V-20059 and sterile water for Injection Reg.No. 053244 Batch No.w-20017,Manufactured by M/s Mediate Pharmaceuticals (Pvt) Ltd, Karachi

Medical Product Alert-Hilixophin 500mg injection

Manufacture and sale of sub-standard Hilixophin 500mg Injection(Vial) Reg.No 044105,Batch No.V-20085 ,Mfg Date 12-2020 ,Exp Date 12-2022 and sterile water for injection Reg.No.053244,Batch No.W-20024,Mfg.Date 12-2020,Exp Date 12-2023 Manufactured by M/s Mediate Pharmaceutical (Pvt)Ltd, Karachi

Medical Product Alert-Protonix 40mg Tablet

DRUG RECALL of Substandard Protonix 40mg Tablet. Reg. No. 030041, Batch No. 069. Mfg. Date Jan. 2020. Exp. Date Jan.2023. Manufactured by M/s Wilshire Laboratories (Pvt) Limited,Lahore.

Medical Product Alert-Abex Injection

Manufacture & Sale of Adulterated & Substandard ABEX Injection. Reg No. 086072. Batch No. 21AL2. Mfg. Date 02-21. Exp. Date 02-23. Manufactured by M/s, Semos Pharmaceuticals (Pvt,) Ltd.,Karachi.

Medical Product Alert-Conus Injection

DRUG RECALL of Adulterated & Sub-Standard Conus Injection, Reg. No.055956, Batch No. 091, Mfg. Date 06-2020, Exp. Date 12-2021, Manufactured by M/s. Epoch Pharmaceuticals (Pvt.) Ltd., Karachi

Medical Product Alert-Cipracept 250mg Tablet

Drug Recall of Substandard Cipracept 250mg tablet, Reg No.096357, Batch No.TCA-103, Mfg. Date 01-2021, Exp. Date 01-2023, Manufactured by M/S Mission Pharmaceuticals, Karachi.

Medical Product Alert-Klevra OraI Solution

DRUG RECALL of Substandard Klevra Oral Solution. Reg. No. 066831. Batch No. 0N152. Mfg. Date Dec. 2020. Exp. Date Dec. 2022. Manufactured by M/s. PharmEvo (Pvt.) Ltd. Karachi

Medical Product Alert-Parapals Infusion 1000mg/vial

DRUG RECALL OF Adulterated & Sub-Standard Parapals Infusion. Reg. No.088360. Batch No. LI-048 & LI-050 Mfg. date 01-2020. Exp. Date 01-2022. Manufactured by M/s Inventor Pharma. Karachi

Medical Product Alert

RECALL OF PRODUCTS DUE TO PRINTING MISMATCH WITH RESPECT TO PRODUCT SPECIFICATIONS.

Medical Product Alert

AVAILABILITY OF SPURIOUS "INJECTION PENRO 1000MG. BATCH NO. PO200017" IN THE MARKET.

Medical Product Alert

AVAILABILITY OF SPURIOUS â€œINJECTION PENRO 1000MG. BATCH NO. PO200138â€ IN THE MARKET.

Medical Product Alert -Pantopep Tablets

DRUG RECALL OF SUBSTANDARD PANTOPEP TABLETS, BATCH NO. 911, REG. NO. 064137. MANUFACTURED BY M/S HASSAN PHARMACEUTICALS (PVT.) LTD., PESHAWAR.

Medical Product Alert- MB-Chlor Eye Drops

CORRIGENDUM

DRUG RECALL OF SUBSTANDARD MB-CHLOR EYE DROPS REG NO. 024555. BATCH NO. 177. MANUFACTURING DATE 06.2019. EXPIRY DATE 06.2021. MANUFACTURED BY M/S MBL PHARMA. LASBELA

Medical Product Alert

DRUG RECALL OF VARIOUS PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES IN THE MONTH OF OCTOBER 2020.

Medical Product Alert -Penro Injection 1000mg

RECALL OF PENRO INJECTION 1000MG CLAIMED TO BE MANUFACTURED BY M/S BOSCH PHARMACEUTICALS (PVT.) LTD., KARACHI.

Medical Product Alert

WHO MEDICAL PRODUCT ALERT N⁰6/2020-FALSIFIED FLUZONEÂ® QUADRIVALENT INFLUENZA VACCINE

Medical Product Alert -Torfen (Ibuprofen 200mg/5ml) Suspension

DRUG RECALL OF SUBSTANDARD Sub-Standard Torfen Suspension. Reg. No. 073895. Batch No. 035. Mfg. date 06-20. Exp. Date 05-22. Manufactured by M/s Kaizen Pharmaceuticals, (Pvt) Ltd.,Karachi

Medical Product Alert -Caflam 50mg SCT

Voluntary Pre-Cautionary Recall of Caflam 50mg SCT Batch No.W72G Manufactured by M/S GSK Consumer Healthcare Pakistan Limited, Jamshoro for M/S Novartis Pharma Pakistan Limited Karachi

Medical Product Alert -Azomax 500mg FCT

VOLUNTARY PRE-CAUTIONARY RECALL DUE TO POTENTIAL MIX-UP IN AZOMAX 500MG FCT BATCH NO. LJ2L MANUFACTURED BY M/S GSK CONSUMER HEALTHCARE PAKISTAN LIMITED, JAMSHORO FOR M/S NOVARTIS PHARMA (PAKISTAN) LIMITED. KARACHI.

Medical Product Alert -PARAPALS INFUSION 100ML

RECALL OF PARAPALS INFUSION 100ML

Medical Product Alert - AQUA-NOV INJECTION

DRUG RECALL OF AQUA-NOV INJECTION B# W-214 MFG. BY M/S NOVARTANA PHARMACEUTICALS (PVT.) LTD. 7-B SUNDAR INDUSTRIAL ESTATE. LAHORE.

Medical Product Alert - OXIPHIN 1G INJECTION

DRUG RECALL OF OXIPHIN 1G INJECTION (PACK CONTAINS OXIPHIN 1G INJECTION BATCH NO.B# KG20033 MFG. BY M/S KANEL PHARMACEUTICALS,ISLAMABAD & AQUA-NOV INJECTION B# W-214 MFG. BY M/S NOVARTANA PHARMACEUTICALS (PVT) LTD., 7-B SUNDAR INDUSTRIAL ESTATE,LAHORE).

Medical Product Alert -PARAPALS INFUSION 100ML

RECALL OF PARAPALS INFUSION 100ML

Medical Product Alert - MB-CHLOR EYE DROPS

DRUG RECALL OF SUBSTANDARD MB-CHLOR EYE DROPS REG NO. 024555. BATCH NO. 177 MANUFACTURING DATE 06-2019, EXPIRY DATE 06-2021, MANUFACTURED BY M/S MBL PHARMA, LASBELA

Medical Product Alert - XYLOP 1% INJECTION

DRUG RECALL OF XYLOP 1% INJECTION BATCH NO. BBH06 MANUFACTURED BY M/S PALPEX PHARMACEUTICALS(PVT) LTD., KARACHI.

Medical Product Alert - Water for injection

DRUG RECALL OF WATER FOR INJECTION B# WFI-237 MFG.BY M/S AMMER AND ADNAN PHARMACEUTICALS, LAHORE.

Medical Product Alert - OXIPHIN 1G INJECTION

DRUG RECALL OF OXIPHIN 1G INJECTION (PACK CONTAINS OXIPHIN 1G INJECTION BATCH NO B# KH20002, KH20003, KH20007, KH20011 MFG.BY M/S KANEL PHARMACEUTICALS, ISLAMABAD & WATER FOR INJECTION B# WFI-237 MFG.BY M/S AMMER AND ADNAN PHARMACEUTICALS, LAHORE).

Medical Product Alert - KANBACT 500MG INJECTION

DRUG RECALL OF KANBACT INJECTION 500MG (PACK CONTAINS KANBACT INJECTION BATCH NO.KH20017 MANUFACTURED BY M/S KANEL PHARMACEUTICALS, RAWAT, ISLAMABAD AND XYLOP 1% INJECTION BATCH NO. BBH06 MANUFACTURED BY M/S PALPEX PHARMACEUTICALS(PVT) LTD., KARACHI.

Medical Product Alert - ZENTAL SUSPENSION

RECALL OF ZENTAL SUSPENSION MANUFACTURED BY M/S GSK PAKISTAN LIMITED. KARACHI.

Medical Product Alert - FENACLOD INJECTION

DRUG RECALL OF ADULTERATED & SUBSTANDARD FENACLOD INJECTION, REG NO. 050475, BATCH NO.039 MFG. DATE 10-2019, EXP.DATE 10-2021 MANUFACTURED BY M/S EPOCH PHARMACEUTICALS, KARACHI

Medical Product Alert - FLAZOL INFUSION 500mg/100ml

VOLUNTARY RECALL OF FLAZOL INFUSION 500MG/100ML, BATCH NO. F19135 & F19125,MANUFACTURED BY M/S BOSCH PHARMACEUTICALS(PVT) LTD., KARACHI.

Medical Product Alert - Parapals Infusion 100mL

RECALL OF PARAPALS INFUSION 100ML.

Medical Product Alert - Medisol Compound Sodium Lactate IV Infusion 500ML

RECALL OF MEDISOL COMPOUND SODIUM LACTATE IV INFUSION 500ML

Medical Product Alert - FALSIFIED CHLOROQUINE PRODUCTS CIRCULATING IN THE WHO REGION OF AFRICA

Medical Product Alert - Colicraft Lyophilized Powder for injection & Infusion

Drug Recall of substandard Colicraft lyophilized powder for injection & infusion.Reg No 082407,Batch No L-279, MFG. Date 02-2020,EXP Date 01-2022 Manufactured by M/S BIOLABS(PVT)LTD Islamabad.

Medical Product Alert - Minirin Nasal Spray

VOLUNTARY RECALL OF MINIRIN NASAL SPRAY IMPORTED BY M/S ATCO LABORATORIBS LIMITED. KARACHI.

Medical Product Alert - Hydryllin Sugar Free Syrup

Drug recall of Hydryllin Sugar free Syrup Batch No. B0003,B0009,B0243,A0013,A0014,A0015,A0016 and A0017 Reg No.058021

Medical Product Alert - Voluntary Recall of Herceptin Solvent Vials-20ml Batch Number: N7396B04 Due to Glass Particles in Solvent Vials

Voluntary Recall of Herceptin Solvent Vials-20ml Batch Number: N7396B04 Due to Glass Particles in Solvent Vials

Medical Product Alert - Dopacin Injection (Dopacin HCI) 200mg/5ml Batch No. DP-02

Drug recall of DOPACIN INJECTION (DOPAMINE HCI) 200mg/5ml Batch No. DP-020, Reg. No. 081861, Mfg. Date 11-2019, Exp. Date, 11-2021, M/S MTI Medical (PVT} Ltd, 586-587, Sundar Industrial Estate, Lahore-Pakistan

Medical Product Alert - Mariadin Injection (Ranitidine (as HCl) 50mg/2ml)

M/s Elite Pharma (Pvt.) Ltd. voluntary product recall of Mariadin Injection (Ranitidine (as HCl) 50mg/2ml) Batch No. 113

Medical Product Alert - Nexalite Injection (Tranexamic Acid 250mg/5ml)

M/s Elite Pharma (Pvt.) Ltd. voluntary product recall of Nexalite Injection (Tranexamic Acid 250mg/5ml) Batch No. 028

Complaint regarding use of RESTANE (ISOFLURANE) B.NO.NO219d16- Interim Report

M/s Allied Distributor (the importer & product license holder in Pakistan) has disowned the sealed portion of sample of said drug sample which shows that the suspected drug was supplied through unauthorized source

Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS)

Safety alert - Increased rate of major adverse cardiac events observed in patients receiving Bioresorbable Vascular Scaffold (BVS)

Testing of 171,375 samples ensured under campaigns to curb spurious drugs sale

DRAP,as part of its special campaigns against spurious drugs in the country, has ensured testing of 1,71,375 samples at its laboratories during two years and nine months.

Jumex (Selegling HCL) 5MG, Tablets

Sanofi A-ventis Pak Ltd. recalled Jumax 5mg Tablets, Reg No:0101215 Batch No:7V001