The continued fall out from Sri Lanka’s disastrous medicine and pharmaceutical procurement and regulatory failures from the last two years continues as the Health Ministry commenced an investigation into the alleged haphazard storage of medicine consignments at the Sri Lanka Customs terminals in Wattala and Kelaniya.

Speaking to the media, a Deputy Director General of the Ministry of Health acknowledged that glass particles had also been found inside the vials of the antibiotic named ‘Meropenem’ stored within the terminals. Meanwhile, three members of the Board of Directors of the National Medicines Regulatory Authority (NMRA) yesterday resigned citing the criticisms levelled at the NMRA regarding the controversial human intravenous immunoglobulin (IVIG) purchase, which occurred via a Waivers of Registration (WoRs), and over alleged irregularities by the current NMRA administration. This, weeks after former Minister of Health, Keheliya Rambukwella was arrested and remanded over the IVIG import, several senior government officials, including the former Secretary to the Ministry of Health and the former Chair of the NMRA have also been taken to custody, in what is a ‘national-first’ for Sri Lanka, in its pursuit combatting corruption.  

As more information comes to light about the scale and frequency of corruption and malpractice in the purchase of medicine, it is now undeniable that the Health Ministry’s catastrophic ‘fast-track’ emergency procurement scheme which led to counterfeit medicines inflowing to public sector hospitals, should be a practice that’s blacklisted by the Government. With evidence regarding multiple such instances coming to light, before courts and in the public domain, it is clear that some form of organised effort has been underway to buy medicines (side-stepping the normal registration process) on the basis of bids from private suppliers, even if consignments from previous orders were on the way. The sheer scale and audacity of the corruption which is coming to light would have caused a government to resign if in another country. However, in Sri Lanka accountability and good governance has been in short supply. 

It is clear that while some drugs which were on order, with consignments expected, were ‘re-ordered’ via the fast-track system which was introduced during the height of the Covid-19 pandemic. Why this type of operation did not raise red flags, and if it did, why they were ignored is a question senior officials at the Ministry of Health must answer. However, such malpractice was only reported to the public by hard working journalists, who despite significant resistance and pressure, continued to investigate and inform the public about the issue. A question which remains unanswered is how the consignment of human intravenous immunoglobulin (IVIG) which had been imported by the local supplier named Isolez Biotech Pharma AG was paid for? Such ‘fast-tracked’ purchases were planned to be executed under the Indian line of Credit which was offered to Sri Lanka early on during the crisis to import required medicines, among other goods. Those who imported or locally ‘developed’ such substandard medicines and sold it to the State, were only able to do so because there was an ‘emergency purchase’ mechanism, which was allowed to function, even after concerns were raised about it. The practices of granting a Waivers of Registration (WoRs) had also been abused to facilitate this crime against Sri Lanka’s most vulnerable people. Such practices and the entire medicine purchasing mechanism must be reviewed, a forensic audit carried out, and the practices which enable corruption rooted out.

Another glaring shortcoming which was highlighted last year was that Sri Lanka does not have a well-equipped and up-to-date laboratory to test the quality of medicines and pharmaceuticals that are imported every year. The 30-year-old National Medicines Quality Assurance Laboratory (NMQAL) designated for medicine quality testing situated at the National Medicines Regulatory Authority (NMRA) was in a dilapidated condition. It is also learnt that several instruments in the laboratory are not in operational condition. The laboratory had submitted documents to obtain standard certifications from the International Organisation for Standardisation (ISO), but had been rejected as the organisation had requested a number of changes to the entire laboratory for it to be reviewed for standardisation. This is an area which is vital for Sri Lanka to ensure compliance with its medical regulatory system. As such, it is the duty of this Government, or one that will be formed in the near future to completely overhaul the medicine purchase mechanism, include better transparency and oversight to it, and to have a robust, and well-resourced regulatory mechanism, which is answerable to Parliament, to ensure that the tragedies of 2022-23 are never repeated.