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Month: June 2023

Rapid Alert; H&OTC Product: Falsified and Unregistered N-Gaisk Plus Tablets by M/s Naz Homoeo Pharmacy

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Rapid Alert

Falsified and Unregistered N-Gaisk Plus Tablets

DRAP Alert NoNo  II/S/06-23-27
Action Date19th June 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 took the sample of N-Gaisk Plus Tablets and sent it to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Un-registered under the Drugs Act 1976

The product detail as under: –

Therapeutic Goods Affected:-

SrProduct NameBatch #Manufactured by Remarks
1N-Gaisk Plus Tablets
 
Registration No.: Nil

Mfg. Date: Aug 2022
Exp. date: Aug 2028		004M/s. Naz Homoeo Pharmacy, KarachiDiclofenac sodiumhas been identified on assay test (24.81mg) which is an allopathic drug and the sample is not registered with DRAP. Hence sample is declared as “Un-registered Drug Product”
Risk Statement:The Claimed Product is Homoeopathic with some quantity of an allopathic ingredient Diclofenac Sodium which is an Anti-Inflammatory/Rheumatic drug used to treat Rheumatoid Arthritis and associated pains. As the product is unregistered this infers that the quality and safety attributes of the product are not accepted and approved by DRAP.

Unregistered products containing Diclofenac Sodium may cause severe adverse reactions including Gastric bleeding and diarrhea.
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 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.

Rapid Alert; H&OTC Product: Falsified and Unregistered Sugar XL Capsules by M/s Naz Homoeo Pharmacy

Asad Ullah Recall Alerts
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Rapid Alert

Falsified and Unregistered Sugar XL Capsules

DRAP Alert NoNo  II/S/06-23-26
Action Date19th June 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 took the sample of Sugar XL capsules and sent it to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Unregistered under the Drugs Act 1976.

The product detail as under: –

Therapeutic Goods Affected:-

SrProduct NameBatch #Manufactured by Remarks
1Sugar XL Capsules
 
Registration No.: Nil

Mfg. Date: Nil
Exp. date: use within 5 years		NilM/s. Naz Homoeo Pharmacy, KarachiGlibenclamide has been identified on an assay test (3.34mg) which is an allopathic drug and the sample is not registered with DRAP. Hence the sample is declared as “Un-registered Drug Product.”
Risk Statement:The Claimed Product is Homoeopathic with some quantity of an allopathic ingredient Glibenclamide which is an oral hypoglycemic drug used to treat type 2 diabetes. As the product is unregistered this infers that the quality and safety attributes of the product are not accepted and approved by DRAP.
 
Unregistered products containing Glibenclamide may cause adverse reactions including variation in blood glucose level which may lead to hypoglycemic conditions and the patient may get faint.
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 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.

Rapid Alert: Drug Product; Falsified Defitelio Infusion  identified in the WHO Regions of Europe and the Eastern Mediterranean

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Rapid Alert

WHO Medical Product Alert N°3/2023 On Falsified DEFITELIO (defibrotide sodium)

DRAP Alert NoNo  I/S/06-23-25
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics, etc.
3. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
4. Patients, Caregivers, and General Public.
Problem StatementWHO issued Medical Product Alert No. 3/2023 on falsified batch No. 19G19A, Expiry Date 01/2025, of DEFITELIO identified in the United Arab Emirates and publically reported by the national regulatory authority (in November 2022). The falsified batch was also identified in Kyrgyzstan (in March 2023). They have been identified in UK/Ireland packaging and US packaging. This falsified product is not registered in Pakistan.
The genuine manufacturer of DEFITELIO has confirmed that the products referenced in WHO alert are falsified. Lab analysis of a sample of falsified products found it did not contain any of the stated active ingredients. The genuine manufacturer has also advised that:
    i.  Stated batch number 19G19A is not a genuine DEFITELIO batch number
    ii.   Expiry dates are falsified
    iii.   Falsified US pack with batch 19G19A / Exp. 01/2025- the vial inside the pack has a different batch number- M06B466E which is not a genuine batch number.
Therapeutic Goods Affected:-DEFITELIO 80 mg/ml Concentrate for Infusion
Active Ingredient: (Defibrotide Sodium)
Registration No.: Nil
Batch No. Outer carton Batch: 19G19A Exp. date: 01/2025 and Inner vial Batch: M06B466E
Purported Manufacturer (as per label) M/s. Gentium SRl

For further information please click for details of the affected products.
Risk StatementDEFITELIO (Defibrotide sodium) is an antithrombotic agent used to treat severe venous-occlusive disease (VOD) in adult and pediatric patients undergoing hematopoietic (blood) stem cell transplantation.
·         Use of falsified products will compromise the treatment of disease and may intensify the existing condition.
·         It may lead to life-threatening reactions due to intravenous administration as safety, sterility and quality of product are unknown.
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate the batch of products if available. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this batch product. The remaining stock should be quarantined immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) in order to ensure the removal of these products.
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.

-Pharmacists and procurement officers present at healthcare facilities are requested to remain vigilant and inform patients of procuring medical products only from authorized channels.

-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 ConsumersTo ensure authenticity, consumers should always obtain medical products from authorized licensed pharmacies /outlets. The authenticity of these products should be carefully checked and If the consumer has any doubt, advice must be sought from your pharmacist.

In case a consumer has experienced any problem related to taking or using these drug product(s), they should cease the use of the product in question immediately and contact their Physician or Pharmacist and should also report the incident to the Drug Regulatory Authority of Pakistan.

Rapid Alert; Drug Product: Falsified Ciproxin 500mg Tablets identified in the Market

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Rapid Alert

Falsified Ciproxin 500mg Tablets

DRAP Alert NoNo  II/S/06-23-28
Action Date19th June 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores
3. General Public
Problem StatementProvincial Drug Control team has seized suspected falsified Ciproxin 500mg Tablets during the market surveillance activities in the District Kasur, Punjab. The Manufacturing Authorization holder company i.e. M/s Bayer Pakistan (Pvt) Ltd, Karachi has stated that based on the physical verification of security features, the products seized are not genuine, and thus it is a spurious/falsified products.

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)
1Ciproxin 500mg Tablets

Mfg.Date: 12-21
Exp.Date: 11-26		CiprofloxacinBAA928M/s.Novartis Pharma (Pakistan) Ltd, Karachi
For Bayer Pakistan (Pvt) Ltd, Lahore
Risk Statement:Consequences of use of Spurious/ Falsified Drugs includes but not limited to followings:
-Falsified/Spurious drugs may contain toxic and narcotic/psychotropic ingredients in unacceptable doses which may be life threating.
-These are manufactured under unhygienic condition without the proper inspection and approval, which are highly injurious to human health.
-Poor-quality medicines compromise the treatment of diseases and may intensified 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.

Notification: Application on Form-5F (CTD) for Extension in the Contract Manufacturing Permission of Drugs.

Ijaz Mustafa Drugs, General, Regulatory Updates

Drug Regulatory Authority of Pakistan on the recommendation of the Registration Board has revised the data requirement for submitting applications for extension in the contract manufacturing permission of the drugs for those product where CTD dossiers has already been submitted and approved by the Registration Board. The Notification issued in this regard is as under:-

notification_contract_manufacturing_2Download


SRO 685(I)/2023 dated 09-06-2023: Amendments in the Bio Study Rules, 2017

Asad Ullah Clinical Trials, SROs

The Drug Regulatory Authority of Pakistan, with the Federal Government’s approval, has made amendments to the Bio-Study Rule 2017. Through this amendments, the Application Form (Form-IIA) for BA/BE Studies has been revised to rationalize the requirement for submission of the reference product’s Certificate of Pharmaceutical Products (CoPP). The Notification issued in this regard is as under:-

S.R.O.-685-Form-IIADownload

Rapid Alert; Drug Product: Falsified Phenobar 30mg Tablets identified in the Market

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Rapid Alert

Falsified Phenobarbitone 30mg Tablets

DRAP Alert NoNo I/S/06-23-24
Action Date5th June 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores
3. General Public
Problem StatementDrug Inspectorate field force including various Provincial Inspector of Drugs took samples of Phenobar 30mg Tablets from the market and asked the manufacturer stated on the label for verification of authenticity. The purported manufacturer i.e. M/s Star Laboratories (Pvt) Ltd., Lahore, has informed that following batches were not manufactured by them.

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)
1Phenobar Tablets 30mgPhenobarbitoneQA019,
QA025,
QA016.		M/s Star Laboratories (Pvt) Ltd .Lahore
Risk Statement:Consequences of use of Spurious/ Falsified Drugs includes but not limited to followings:
-Falsified/Spurious drugs may contain toxic and narcotic/psychotropic ingredients in unacceptable doses which may be life threating.
-These are manufactured under unhygienic condition without the proper inspection and approval, which are highly injurious to human health.
-Poor-quality medicines compromise the treatment of diseases and may intensified 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.