Sri Lanka’s Medicine Regulatory Authority (NMRA) is to charge a fee of $50 on all pharmaceutical import applications it receives and assesses, as it had forgone $23,950 in income last year by not charging a fee for each application, NMRA Chairperson Dr. Ananda Wijewickrama told the Committee on Public Finance on Wednesday (3).
“Last year we received 1,173 applications for sample imports, and out of these, only 694 licences were approved. Previously the fee was only charged for approved licences, that is $ 100 each,” Wijewickrama said, referring to amendments to be introduced through a new gazette, Gazette No. 2452/39 issued on 4 September 2025.
“So we got an income of $ 69,400. If the new gazette was applied, there would be a $ 50 fee for each application that is assessed and evaluated, and another $ 50 for the approved licence.”
Wijewickrama said that if the $ 50 fee had been applied to each sample import application last year, the Authority would have earned $ 93,350 in income for 2024. “Altogether the income would have been $ 93,350 for 2024 for this purpose. That is why we have divided this fee. We have basically not increased the fee for a person who is getting registration, but we have divided it so the processing of rejected applications will also incur a fee.”
Sri Lanka’s State Pharmaceutical Corporation (SPC), the Government-owned entity which acts as the main importer and supplier of essential medicines, surgical items, and lab supplies to public hospitals, has so far incurred Rs. 90 billion in orders in 2025, as stated by Health Minister Nalinda Jayatissa in October.
Accordingly, another Rs. 20 billion is to be allocated within the year. Last year, Sri Lanka spent $ 48 billion on imported medicine, according to the SPC. Jayatissa attributed this increase to the medicine shortages experienced during Sri Lanka’s economic crisis and subsequent recovery period. To shorten lead times to deliver medicines to the market, purchasing was subsequently increased within the year.
Furthermore, according to Wijewickrama, the NMRA is to waive fees for the registration of medicines administered for rare diseases and those with low consumption. “We wanted to waive the fees which were applicable for registration of medicines used in rare diseases, and also medicines used in small quantities. The reasons were that suppliers are not interested in registering these medicines because they are used in small quantities, and they don’t get a profit from them. What we thought was to waive the registration fee and other applicable fees to encourage them to register these medicines so that we can ensure the quality of these medicines which are used for our patients.”
Additionally, the Chairperson said that the retail pharmacy registration annual fee, which had previously been $ 45, is now to be extended for a three-year period, but with an additional $ 90 processing fee. “For retail pharmacy registration, previously it was charged $ 45 per annum. Now we are introducing a processing fee of $ 90, and a licence fee of $ 45 for three years.”
“Then there is an amendment for the clinical trial charges. Previously we charged $ 250 for all applicants. Now, $ 250 is only for industry-sponsored applicants, whereas a $ 50 charge is for academics with international sponsorships, and it will be free for local investigator-sponsored trials,” Wijewickrama added.
He concluded that a licensing fee for importer applications, which had not existed previously, is to be introduced at a rate of $ 500.