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Author: Yasir Mahmood

Annual Schedule for the CSC Meetings for the year 2025

Yasir Mahmood Clinical Trials

The Clinical Studies Committee (CSC) of Drug Regulatory Authority of Pakistan (DRAP) is mandated under Bio Study Rules 2017 for the regulatory oversight of clinical trials and clinical studies related to therapeutic goods in the country. The CSC reviews and approves clinical study protocols, ensuring they adhere to ethical and scientific standards. It also monitors ongoing clinical trials to assess participant safety and efficacy, makes informed decisions regarding study design, and collaborates with researchers, sponsors, and other stakeholders to ensure quality clinical research and safety of the participants.

The Committee has decided that the CSC meetings will be convened after every 45 days and an annual CSC meeting schedule for 2025 (tentative) has been issued with the aims to enhance transparency, efficiency, and collaboration.

S. No.CSC MeetingProposed Date
0154th CSC Meeting28th – 31st January 2025
0255th CSC Meeting03rd – 08th March 2025
0356th CSC Meeting21st – 25th April 2025
0457th CSC Meeting26th – 31st May 2025
0558th CSC Meeting07th – 11th July 2025
0659th CSC Meeting25th – 29th August 2025
0760th CSC Meeting01st – 03rd October 2025
0861st CSC Meeting08th – 12th December 2025
1.-Annual-Tentative-Plan-for-CSC-MeetingDownload

Caution Regarding Fake Emails Impersonating DRAP Officials

Yasir Mahmood General ,

It has come to our attention that some individuals are receiving fraudulent emails impersonating officials of the Drug Regulatory Authority of Pakistan (DRAP). Please be advised that all official DRAP correspondence comes from email addresses ending with @dra.gov.pk.

Stakeholders and the public are urged to remain vigilant and verify the authenticity of any communication. If in doubt, kindly contact DRAP through official channels.

Thank you for your attention to this matter.

Drug Regulatory Authority of Pakistan

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.