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Author: Yasir Mahmood

Rapid Alert: Drug Product Recall: Incidents of loss and damage of vision with the off-label use of Avastin 100mg/4ml injection

Yasir Mahmood Recall Alerts , ,

Information Update on 3rd Nov, 2023: The recall of Avastin 100mg/4ml has been terminated based on the report of Central Drugs Laboratory, Karachi which declared the samples as of standard quality.

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Rapid Alert

DRAP Alert NoNo  I/S/09-24-36
Action DateSeptember 24, 2023
Target Audience1. Ophthalmologists and Endocrinologists
2. Healthcare Professionals – Physicians, Pharmacists, and Nurses.
3. Regulatory Field Force.
4. General Public
Problem StatementIncidents of loss of vision in diabetic patients have been reported following treatment with Altered/Dispensed/Diluted Avastin injection. This product is approved by the Drug Regulatory Authority of Pakistan (DRAP) to treat Colorectal and other metastatic carcinomas. The use of this drug product in diabetic retinopathy or other ophthalmic conditions is one of the off-label uses and is not approved by DRAP.

The incident is linked with the alteration/dispensing/dilution and sale of Avastin 100mg/4mL Injection under unhygienic/non-sterile conditions illegally and without any Drug Sale/Dispensing License (DSL) from Provincial Health Authority by M/s Genius Advanced Pharmaceutical Services Lahore.
Threats to Public HealthAvastin is a registered drug of M/s. Roche Pharma in Pakistan and is available in strength of 100mg/4ml and 400mg/16ml preparations. This drug is indicated for the treatment of colorectal and other metastatic carcinomas as a VGRF (vascular endothelial growth factor) inhibitor.

However, the use in diabetic retinopathy is an off-label use to block the growth of abnormal blood vessels in the eye. Since this drug was being dispensed/diluted/repacked in 1.25mg/0.05ml dose under unhygienic conditions and in an unapproved manner, therefore, its safety cannot be ascertained which may lead to damage and loss of vision in the patients.

The product identification details are as under: –

Therapeutic Goods Affected:-

Following is the detail of the alleged product:

Product InvolvedManufacturer
Inj. Avastin 1.25 mg/0.05ml

Composition: Bevacizumab
Registration No. Nil		Genius Advanced
Pharmaceutical Services.
Un-registered Product

Following is the detail of DRAP approved product:

Product NameSuspected BatchManufacturer/Importer
Avastin 100mg/4ml Injection


Composition: Bevacizumab
Registration No. 043004		H0352B11
B7266B20
B7266B07		M/s Roche Diagnostics, Germany


Importer:
M/s Roche Pharma, Karachi.
Registered Product
Action InitiatedThe Regulatory field force raided the premises of M/s Genius Advanced Pharmaceutical Services, Lahore, involved in the repacking and dispensing of Avastin injection under unhygienic/non-sterile conditions. The premises have been sealed and legal proceedings have been initiated against the personnel involved.

The Importer of the registered product has been directed to recall the suspected batches of Avastin 100mg injection from the marked immediately. The sale/distribution of registered Avastin Injection has been put on halt till verification of its quality through sampling and laboratory testing to safeguard public health. Healthcare Professionals, Pharmacists and Chemists have been directed to stop the distribution, dispensing and administration of this product immediately, and check their stocks and stop supplying this product. The remaining stocks should be quarantined and returned to the supplier/company.
Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities regarding the off-label use of this product.

-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 ConsumersPatients should not use this product for any ophthalmic disease and should 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.

DRAP asks stakeholders to comment on the draft guidelines on Bio-availability & Bio-equivalence studies for generic drug products

Yasir Mahmood Drugs, Regulatory Updates

The Drug Regulatory Authority of Pakistan (DRAP) ensures that all pharmaceutical drug products conform to acceptable standards of safety, efficacy and quality. This guidance will be applicable to orally administered generic drug products as well as to non-orally administered pharmaceutical products for which systemic exposure measures are suitable for documenting bioequivalence.

This document will provides guidance to the industry for in vivo and in vitro requirements to assure interchangeability of the generic product without compromising the safety, quality and efficacy of the pharmaceutical product.

Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to abdullah.diyo∂dra.gov.pk, copying at muneeb.cheema∂dra.gov.pk, or can post at mailing address Additional Director, Pharmaceutical Evaluation and Registration, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click to view the “Draft Guidelines on Bio-Equivalence (BE) / Bioavailability (BA) Studies for Generic Drug Products”

Stakeholders comments are invited on draft Guidelines for Labeling & Packaging of finished drug products.

Yasir Mahmood Drugs

This guidelines are aimed to assist industry (marketing authorization holders) in drawing up the label and package leaflet for their products in compliance with the Drugs (Labelling and Packing) Rules 1986. This documents will provide specific requirements for the labelling and packaging of pharmaceutical and biological drug products.

The purpose of the guidelines are:-

  1. To provide guidance on how to ensure that the information on the label and package leaflet is accessible to and can be understood by those who receive it, so that they can use their medicine or ensure its use safely and appropriately.
  2. To help achieve consistency, transparency, clarity, efficiency and high quality in both the content and management of reviews.
  3. This guideline is written to assist applicants and marketing authorization holders when drawing up the label and package leaflet

Stakeholders can submit their comments and suggestions with 15 days of uploading of this document using prescribed format to submit comments (link to access table of comments), and forward via email to abdullah.diyo∂dra.gov.pk, copying at muneeb.cheema∂dra.gov.pk, or can post at mailing address Additional Director, Pharmaceutical Evaluation and Registration, 4th floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click here to view draft guidance document Draft Guidelines on Labelling and Packaging of Drug Products

Deficiency Letters from EEC meetings from 95 to 103

Yasir Mahmood Alternative Medicines, Enlistment Evaluation Committee
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