• Backlog tied to new regulatory approach

The Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) yesterday (7) warned that the country is facing a looming shortage of essential medicines by March and April due to a significant backlog in licence renewals at the National Medicines Regulatory Authority (NMRA).

The industry body claimed that over 750 import licence renewals were currently pending – a delay that prevents companies from placing necessary orders with international suppliers.

SLCPI President Shantha Bandara explained that the situation had become critical due to the lead times required in the global supply chain.

He noted that the pharmaceutical industry generally required 90–120 days to replenish stocks and the current administrative bottleneck was effectively halting this process.

“If the authority continues to allow hundreds of licence renewals to remain pending, we will be unable to place orders in a timely manner, which means we might run out of stock for chronic care items, acute pain relief medication, and other essential treatments,” he added.

The backlog is reportedly tied to a new regulatory approach where the NMRA has integrated price reviews into the annual licence renewal cycle.

Bandara noted that this shift, following a gazette notification on 21 July 2025, had fundamentally slowed down the approval process, given that the NMRA currently lacked the bandwidth to process these applications.

In response to these industry concerns, NMRA Chairman Dr. Ananda Wijewickrama maintained that the authority was following the law and regulations, ensuring that price and quality conditions were met before any renewals were granted.

“We will proceed with the renewal of those licences prior to their expiry provided that the importers fulfil all necessary regulatory conditions, including adherence to established pricing, and in such instances, there is no issue with the renewal process.”

The NMRA is also strictly enforcing the statutory requirements found within the NMRA Act No.5 of 2015.

Dr. Wijewickrama stressed that the law provided for the automatic cancellation of licences if they were not renewed within a specific timeframe following their expiration.

When asked about the enforcement of Clause 101, Sub-Section 2 of the act, Dr. Wijewickrama stated: “This is a requirement stipulated in the act, and as it is the law of the land, we are strictly adhering to those statutory provisions.”

The industry, however, expressed concerns regarding the regulatory body’s reliance on manual systems that could not keep pace with the demand.

Bandara pointed out that without a more robust and rapid system to clear the current backlog, the availability of life-saving medications for conditions such as diabetes and heart disease would be compromised.

He stated: “The Minister may issue instructions, but the authority must be capable of executing them. We are currently calling for a rapid project or a systemic change to clear this backlog and allow us to continue the vital work of supplying Sri Lanka with pharmaceuticals.”

Regarding retail pharmacy licences, the authority has provided a deadline of 28 February for renewals, provided that the establishments employ qualified professionals.

Dr. Wijewickrama confirmed that the presence of a certified pharmacist remained a mandatory requirement for any pharmacy to operate legally.

The SLCPI has urged the Ministry of Health and the NMRA to implement an emergency project to clear the pending applications, ensuring that patient rights to access medication are not infringed upon by administrative delays.