Concerns raised over imported Rapid Antigen Test kits

Colombo (News 1st): Since the 15th of October operations of the National Medicines Regulatory Authority (NMRA) have been conducted online or through the automation system. As such, registering drugs or medical devices can only be carried out online to date. Contrary to this decision on the 19th of October, a set of Rapid Antigen Test kits imported to the country by George Steuart Health Private Limited had been approved by the NMRA to be sold to healthcare institutions. A technical evaluation conducted on the 20th of October on the imported test kits has revealed 6 defects and shortcomings. According to the evaluation, the certificate issued by the manufacturer of the test kit should be submitted to the NMRA before the sale of the test kit. However, it has not been submitted. The 25 test kits presented for evaluation not bearing proper packaging is also a major cause for concern. What is perhaps the most important comment on the evaluation sheet is the comment which reads " product should be validated in MRI and reports should be submitted before obtaining import licenses". Against the backdrop where many ambiguities have been highlighted on the evaluation sheet, the NMRA has certified the test kit. The certificate has also been signed by the Secretary of the Medical Device Evaluation Committee of the NMRA. Surprisingly, the committee has last convened on the 7th of October. Based on the provisions of the National Medicines Regulatory Authority Act No. 05 of 2015, if any deficiencies are found in the technical evaluation after submitting any drug or medical device for registration, approval should not be granted to register the drug or device in question until the relevant deficiencies are addressed. Nevertheless, the NMRA has overlooked the provisions of the National Medicines Regulatory Authority Act No. 05 of 2015 when approving the Rapid Antigen Test kits in an ad-hoc manner.