Last Updated on March 18, 2024
DRAP regulates therapeutic goods with the aim to ensure that products available in market meet the prescribed standards of quality, safety, and efficacy. When a therapeutic good is suspected of being potentially harmful to consumers due to its defective quality, safety, or efficacy issues, a recall shall be issued to remove the defective product(s) from the market. Companies (manufactures, registration / enlistment holders, importers, etc.,) are obliged to remove a defective product through initiating a recall. For more information on Rapid Alerts and Recall, please click here.
DRAP would like to hear from the consumers about their concerns, if they have experienced any problem with the use of a therapeutic good (e.g. drug, vaccine, medical device or alternative medicine, etc.,) or had any adverse event associated with its use. However, In case you are concerned that you have had a adverse event (unexpected side effect or adverse reaction) to a therapeutic good, you are required to contact your healthcare professionals who can advise on any treatment that may be needed and they can also report to the DRAP on your behalf.
What types of problem can be reported?
Nevertheless, anyone can directly report a problem relating to the use or quality of a therapeutic good to DRAP including patients, caregivers and healthcare professionals. Followings are most common example of problem that can be reported to DRAP:-
Report a COVID-19 Vaccines Reactions: –
To report a COVID-19 vaccines adverse events following immunization, please move on to Med Vigilance E Reporting System or visit our page for more information.
Report an Adverse Event or Unexpected Side effect:-
The DRAP has established both online and manual reporting system for collection of adverse event reports occurring in Pakistan. Please click here for more information on reporting a suspected adverse events or unexpected side effect of a therapeutic goods.
Report a Product Quality Defect:-
Division of Quality Assurance & Lab Testing (QA<) has designed a form to report quality defects for reporting of any defect related to quality matters. The form consists of three parts. 1st part is about reporter information where the reporter enters his contact details. The second part of the form is related to product information. The reporter will submit the details of the product like the name of the product, its strength, Registration number, batch number, dosage form, manufacturing and expiry date and other details. In last part, reporter shall submit the facts of quality defect and submit the form. After submission, the form will be available in QA< Division. QA< Division will evaluate & process the form/application as per provided information and resolve the problem/matter.
If you want to to report a quality defect in DRAP’s regulated products, you may visit our page for knowing how to identify a quality defect and its reporting mechanism to DRAP.
Report Shortage of an Essential Drug:-
DRAP welcomes and encourages reports of essential drug shortage from all stakeholders. Please submit a shortage report at our Toll-Free Number: 0800-03727 (working hours), or send us an email at drugshortages∂dra.gov.pk.