- Of 648 labs, only 36 with SWML, 35 with EPL
- Labs fail to meet CEA requirements
- 17 of 374 registered labs accredited
- CEA delegates power to regions
Nearly 94% of private laboratories across the country are operating without crucial environmental licences mandated by the Central Environmental Authority (CEA) Act, the National Audit Office (NAO) reveals.
The NAO’s recent audit report titled ‘Evaluation of the Performance of the Private Health Service Regulatory Process in Sri Lanka’ has uncovered that out of 648 private laboratories registered with the Private Health Services Regulatory Council (PHSRC), a mere 36 have secured the Schedule Waste Management License (SWML), while only 35 possess the Environmental Protection License (EPL).
The report has also highlighted that a significant number of private laboratories continue to operate without meeting CEA requirements, exposing a severe lapse in both regulatory oversight and environmental stewardship.
According to the CEA, the Environmental Protection Licensing Scheme in Sri Lanka, established under the National Environmental Act, mandates that industries and activities with potential environmental impacts obtain an EPL.
Obtaining an EPL provides legal protection against environmental pollution, promotes sustainable practices, and offers access to advanced pollution control technologies. Compliance with specific standards for wastewater discharge, air emissions, noise, plastic product regulations, and hazardous waste management is required.
Managing hazardous waste, classified as Scheduled Waste under Extraordinary Gazette 1534/18, requires obtaining a licence from the CEA per the National Environmental (Protection and Quality) Regulation No.1 of 2008.
This licence applies to all activities involving handling such waste, including its generation, collection, transportation, storage, recovery, recycling, or disposal.
However, the NAO report has also highlighted that many private laboratories are operating without meeting the CEA Act requirements, although they remain registered with the PHSRC.
As revealed by the NAO, by the end of 2016, the Sri Lanka Accreditation Board (SLAB) had accredited 17 medical and therapeutic laboratories in compliance with ISO 15189:2012, while 374 private laboratories had been registered with the PHSRC, indicating a discrepancy between the number of accredited and registered labs.
Under Sections 3 and 18 of the Private Medical Institutions (Registration) Act No.21 of 2006, the Minister of Health had issued an application form for the registration of private medical laboratories, published in Annex II of Special Gazette No.1521/26 dated 2 November 2007.
According to the audit report, this registration process has revealed several issues: the form has only inquired about waste disposal methods but had yet to require confirmation of obtaining an EPL and SWML for clinical waste disposal as required by the CEA Act.
Additionally, despite the National Health Laboratory Policy – approved by the Cabinet of Ministers on 1 December 2006 – mandating annual inspections and accreditation by the SLAB for all laboratories, the registration form had not addressed whether such a licence had been acquired.
Furthermore, several issues have been noted regarding the accreditation of private medical institutions. Section 13(1) of the Private Medical Institutions (Registration) Act No. 21 of 2006 empowers the minister to establish and enforce accreditation schemes for private medical institutions based on recommendations from the PHSRC, with details outlined in a gazette order.
However, as of 30 June 2023, such orders had not been issued or enacted into law.
Moreover, the guidelines for private medical laboratory services, which the PHSRC had not formally approved as of 19 March 2021, have not emphasised the necessity for accreditation certificates.
Additionally, there was no drive to encourage obtaining international standard certificates, such as ISO 17025 or ISO 15189, for laboratory services. This lack of accreditation and oversight has contributed to eight complaints related to informal activities by laboratories between 2019 and 2022.
Further, the NAO has revealed that the Cabinet had approved the National Health Laboratory Policy on 1 December 2006, intending to collect health-related data from all public and private laboratories and provide it to relevant Government institutions. However, as of 30 June 2023, this objective had not been fully met.
In 2020, the Ministry of Health had initiated awareness programmes encouraging data submission from private hospitals. However, only three out of nine contacted hospitals had provided data on live admissions, discharges, and deaths categorised by disease, gender, and age, with only one submitting data in 2021 and two others between 2021 and 2023.
This lack of comprehensive data from the private sector in the National Health Bulletin, which is essential for informed decision-making, has negatively impacted both national and international decisions.
In clarifying the delay in licensing for laboratories, CEA Chemicals and Hazardous Waste Management Unit Director M.M.C.S.K. Malwana explained that previously, the EPL and SWML had been issued exclusively by the CEA Head Office in Colombo. This centralisation has led to delays as officials needed to travel to various regions.
“However, three months ago, the authority granted the regional offices the powers to oversee these laboratories and issue the required licences, which the regional offices are now undertaking,” Malwana said.
“Currently, we observe a significant reduction in clinical waste being mixed with regular household waste. Previously, items like syringes and plasters were often found in garbage dumps, but such incidents have become minimal.”
He explained that many private laboratories operated on a smaller scale and typically only during evenings, often as part of chains owned by major private hospitals. These hospitals hold the necessary licences and have systems for collecting clinical waste from their affiliated centres.
“With the powers now delegated to the regional offices, it is easier for them to manage these laboratories within their areas. Previously, there were numerous complaints about the high inspection costs, as officials had to travel from Colombo to distant locations.”
Malwana also highlighted that the CEA was currently operating with minimal staff and facing a significant personnel shortage, as per the cadre reviews.