Draft amendments to the Drugs (Labelling and Packing) Rules, 1986, have been published for public information. Comments or suggestions, if any, may be forwarded to director.legal∂dra.gov.pk within seven days of the publication of this notification.
Author: Yasir Mahmood
Disposal of Import cases of Alternative Medicines with short shelf life
Tentative Annual Schedule of the Clinical Studies Committee (CSC) Meetings for the year 2026
The Clinical Studies Committee (CSC) of the Drug Regulatory Authority of Pakistan (DRAP) is constituted under the Bio-Study Rules, 2017 to provide regulatory oversight of clinical trials and other clinical studies relating to therapeutic goods in Pakistan. The Committee reviews and approves clinical study protocols to ensure compliance with applicable ethical, scientific, and regulatory requirements. It also oversees the conduct of approved clinical studies, monitors participant safety and study progress, and makes informed decisions on matters pertaining to the design, conduct, and oversight of clinical research. In carrying out its mandate, the CSC collaborates with researchers, sponsors, and other stakeholders to promote high-quality clinical research while safeguarding the rights, safety, and well-being of study participants.
To enhance transparency, efficiency, and coordination in the conduct of its business, the Clinical Studies Committee has decided that its meetings shall ordinarily be convened at intervals of approximately forty-five (45) days. Accordingly, the tentative Annual Schedule of CSC Meetings for the year 2026 has been issued.
Notwithstanding the tentative annual schedule, the Chairman, CSC, may convene meetings of the Committee at any time, as deemed necessary, to address urgent or emerging regulatory matters.
| S. No. | CSC Meeting | Proposed Dates for CSC Meeting |
| 01 | 61st CSC Meeting | 2nd week of April 2026. |
| 02 | 62nd CSC Meeting | 2nd week of May 2026. |
| 03 | 63rd CSC Meeting | 3rd week of June 2026. |
| 04 | 64th CSC Meeting | 2nd week of August 2026. |
| 05 | 65th CSC Meeting | 3rd week of September 2026. |
| 06 | 66th CSC Meeting | 3rd week of October 2026. |
| 07 | 67th CSC Meeting | 3rd week of November 2026. |
| 08 | 68th CSC Meeting | 3rd week of December 2026. |
Vacancy Announcement for the position of Chief Executive Officer, Drug Regulatory Authority of Pakistan
Request for Expression of Interest (EOI)
Invitation to bid: Provision of housekeeping, janitorial & support staff at DRAP offices
Draft Guidance Document For Clinical Trials Of Biological Products (Manufacture Locally)
For comments of stakeholders
Caution Regarding Fake Emails Impersonating DRAP Officials
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
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.
Rapid Alert
| DRAP Alert No | No I/S/09-24-36 |
| Action Date | September 24, 2023 |
| Target Audience | 1. Ophthalmologists and Endocrinologists 2. Healthcare Professionals – Physicians, Pharmacists, and Nurses. 3. Regulatory Field Force. 4. General Public |
| Problem Statement | Incidents 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 Health | Avastin 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 Involved | Manufacturer |
|---|---|
| Inj. Avastin 1.25 mg/0.05ml Composition: Bevacizumab Registration No. Nil | Genius Advanced Pharmaceutical Services. |
Following is the detail of DRAP approved product:
| Product Name | Suspected Batch | Manufacturer/Importer |
|---|---|---|
| Avastin 100mg/4ml Injection Composition: Bevacizumab Registration No. 043004 | H0352B11 B7266B20 B7266B07 | M/s Roche Diagnostics, Germany Importer: M/s Roche Pharma, Karachi. |
| Action Initiated | The 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 Consumers | Patients 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. |