Despite cutting down a backlog of over 2,400 pending registrations, Sri Lanka’s drug approval process still averages 300 days, Deputy Health Minister Dr. Hansaka Wijemuni told Parliament. The National Drug Regulatory Authority is now working to streamline registration timelines for both local manufacturers and exporters.
Sri Lanka’s pharmaceutical registration process continues to average 300 days, despite significant progress in clearing a massive backlog, Deputy Minister of Health and Mass Media Dr. Hansaka Wijemuni informed Parliament on Wednesday (24).
Responding to a question raised by Samagi Jana Balawegaya Kandy District Councilor Chamindrani Kiriella regarding registration delays for local drug manufacturers and exporters, the Deputy Minister acknowledged the issue but highlighted recent improvements.
Dr. Wijemuni revealed that the number of pending drug registration files with the National Drug Regulatory Authority (NDRA), which stood at over 2,400 as of June this year, has now been reduced to just 200. He added that local pharmaceutical manufacturers no longer face a waiting list and that their applications are processed quickly.
He further explained that although the current timeline for drug registration remains around 300 days after application submission, that figure is consistent with global standards. However, efforts are underway to shorten the process in Sri Lanka, particularly to support the country’s domestic pharmaceutical industry and exports.
Addressing concerns raised by Kiriella about alleged drug shortages, including at Maharagama’s Apeksha Hospital, Dr. Wijemuni stated that there is no significant shortage of medications at the facility. He reassured Parliament that measures are in place to maintain a steady supply across the island’s healthcare network.
The NDRA is now focusing on improving operational efficiency and supporting local pharmaceutical development as part of broader health sector reforms.
