Sri Lanka’s regulator for private medical institutions says it has no capacity to check whether laboratories are using expired dengue test kits, amid speculation that private providers are relying on out-of-date NS1 antigen kits during the country’s worst dengue year on record.
Private Health Services Regulatory Council (PHSRC) secretary Dr. Priyantha Tennakoon told the Daily Mirror that no laboratory may use expired diagnostic kits or reagents — but that the council cannot enforce the rule.
“Right now we cannot carry out monitoring regarding expired test kits as we don’t have a proper work force,” he said. Under the Private Medical Institutions (Regulations) Act No. 21 of 2006, the authorised officer is the provincial director of health services, who is required to inspect laboratories in the province and report. Dr. Tennakoon cited human resource and technical constraints.
A regulator without the tools
Accreditation for private medical institutions in Sri Lanka is voluntary. Dr. Tennakoon said most private hospitals and laboratories are accredited under the Sri Lanka Accreditation Board or hold international certifications such as Joint Commission International, and that the council does not re-evaluate those standards because it lacks the facility to do so.
“For the past 20 years we haven’t set standards that are suitable for Sri Lanka,” he said, adding that a court case over accreditation gradings and charges has been running since 2018 and that the council cannot issue accreditations until judgment is delivered.
He said the PHSRC has been named as the regulatory authority but still lacks the infrastructure to act: “We have submitted gazette notifications for approval but for the past 10 years we haven’t received approval yet.”
National Medicines Regulatory Authority chairman Dr. Ananda Wijewickrama said the NMRA carries out random monitoring and that the expiry date is the standard. He noted that a negative antigen result does not by itself rule out infection. “It is not only the dengue antigen test results that we obtain to determine whether a patient is having dengue. We take a full blood count and also observe their clinical features as well,” he said.
The pricing backdrop
A price ceiling introduced in 2017 set full blood count tests at Rs. 250 and dengue NS1 antigen tests at Rs. 1,000. The Consumer Affairs Authority raised those caps in 2020 under gazette notification No. 2186/17, to Rs. 400 and Rs. 1,200 respectively.
Following recent raids, the CAA clarified that the maximum retail prices have not changed since 2020 and that it will act against institutions charging above them. The Health Ministry directed the CAA in July to intensify inspections of private hospitals overcharging for blood tests.
A doctors’ trade union alliance separately alleged on Monday that price controls have pushed some private hospitals toward lower-quality testing reagents.
