Sri Lanka’s drug regulatory system has “collapsed” and is putting patients’ lives at risk through approval delays and persistent shortages of essential medicines, the Doctors’ Trade Union Alliance for Medical and Civil Rights alleged on Monday.
Speaking to reporters, the alliance’s chairman, specialist Dr. Chamal Sanjeewa, said more than 40 essential medicines have been in short supply for an extended period. Among them he named Oxaliplatin, used in cancer treatment, and Filgrastim, which raises white blood cell counts — leaving cancer patients and others with serious illnesses facing what he called a severe crisis.
Dr. Sanjeewa questioned the nearly two-year delay in approving the Qdenga dengue vaccine and said the National Medicines Regulatory Authority (NMRA) should investigate whether negligence was involved. The NMRA appointed an expert committee in July to assess registering the Takeda-manufactured vaccine, days after India approved the same shot.
Black market and price controls
He alleged that internationally recognised medicines still awaiting approval in Sri Lanka — including Mounjaro, used to treat diabetes and obesity — are already available on the black market, imported and sold without the required cold chain.
“While authorised agents are legally waiting for NMRA approval, black market operators are illegally importing and selling these drugs without maintaining the required cold chain,” he said. “Who will be responsible if someone dies after using them?”
Dr. Sanjeewa also argued that strict price controls have driven established international pharmaceutical brands out of the market, letting in cheaper medicines of questionable quality. The same controls have squeezed laboratory services, he said, alleging that some private hospitals have resorted to lower-quality testing reagents, producing inaccurate reports and the risk of fatal misdiagnosis.
The union proposed an online drug approval tracking system, a fast-track route for internationally recognised medicines, WHO-standard testing of imported drugs, stronger action against the black market, and a more flexible pricing formula tied to global market conditions.
Neither the Health Ministry nor the NMRA had responded to the allegations at the time of reporting.
Jayawardenapura hospital
In a separate claim at the same briefing, Dr. Sanjeewa said the Health Ministry has failed for more than a year to appoint a qualified medical specialist with hospital administration expertise to head Jayawardenapura General Hospital.
The vacancy has created an administrative crisis that is disrupting the hospital’s functioning and adding pressure on specialists and other staff, he said, alleging the institution is being run by people without the necessary qualifications and that patient care could suffer as a result.
He called on President Anura Kumara Dissanayake to intervene and ensure a qualified director is appointed.
The allegations land as the country works through its worst dengue year on record, with 86,386 cases and 62 deaths reported so far in 2026.
