For Market Authorization Holders & Private Pharmacies
Covid-19 Self Test Kits should be approved by DRA prior to sale and distribution. Sale and distribution of COVID-19 self-test kits shall be permitted only from pharmacies under the supervision of a competent person registered with DRA
1. Who all are eligible to apply for Emergency Use Authorization for Covid-19 Self Test Kits?
Answer: Any firm holding Technical Authorization for Sale & Distribution (MAH) issued by the DRA can apply for EUA of Covid-19 Self Test Kits.
2. How to apply for an Emergency Use Authorization for Covid-19 Self Test Kits?
Answer: Please refer The Guideline for Import, Sale, Distribution and Use of COVID-19 Self-Test Kits 2022 (DRA-G-D1-CK-10) available on our website at https://drive.google.com/file/d/1sb1FwANTJhF-pNFIhhtvuKtfoeHDZyNw/view
3. How long does it take to get Emergency Use Authorization?
Answer: EUA would be issued within 10 working days from the date of application if all requirements are met
For The General Public
1. Where can I buy a test kit from?
Answer:Covid-19 self test kits can be purchased from the nearest private Pharmacy.
2. How do I know if the test kit is approved by DRA?
Answer: The approved product list is updated daily in the DRA website (https://docs.google.com/spreadsheets/d/1GJq361ZjkRjMfgJtGAGCSjH0CKh6KlzDKogfX7hg-Ic/edit#gid=0
3. How can I lodge a complaint for test kit related issues such as price, quality etc?
Answer:You can contact us on Facebook (Look out for our official page @ Drug Regulatory Authority, Bhutan), give us a call at 975-2-337074/337075 or write to us at firstname.lastname@example.org
4. How to use the test kits?
Answer: The test kits should be used as per instructions given in the leaflet inside the product package.
5. How to safely dispose of the test kits once used?
Answer:Used self-test kits including the nasal swab are considered as an infectious waste and should be placed in an airtight plastic or disposal bag to avoid the spillage of the waste and can be disposed off along with your household waste.
6. What are the benefits of using DRA approved test kits?
Answer:Since the test kits are approved only after assessment of its quality ( specificity and sensitivity), the chances of encountering substandard products and erroneous results are less.
7. Can self-test kits be used for children?
Answer: Though some of the self-test kits instruct on use of Tests on children between 5 and 10 should always be done or supervised by an adult. For Children below 5, tests should be done by a healthcare professional in flu Clinics.
8. Are Covid-19 self tests kits safe to use? Do they contain toxic chemicals?
Answer: Covid-19 self tests kits are safe to use when people follow the manufacturer’s step by step instructions. However, incorrect use of Covid-19 self tests kits can cause harm if the parts of the test kit, such as liquid solutions in small vials that may contain chemicals like sodium azide, are swallowed or if the liquid solutions touch a person’s skin or eyes. Keep all parts of self tests kits out of reach of children and pets before and after use, and to follow the test’s step by step instructions exactly, including the Warning, Precautions, And Safety Information.
9. Can I use a DRA-authorized Covid-19 self test kit that is expired?
Answer: No, the DRA does not recommend using Covid-19 self tests kit beyond their authorized expiration dates. Covid-19 self tests kits and parts they are made of may degrade, or break down, over time. Because of this, expired test kits could give inaccurate test results.