News
Stinging report on import of medicine: Audit office calls for probe and legal action
View(s):By Namini Wijedasa
In a stinging 887-page report, the National Audit Office (NAO) this week recommended investigations and legal action against “those who endangered sick people by importing substandard medicines”.
The report (which took months to compile) confirms investigations published by the Sunday Times from December 2022 onwards, warning that departure from accepted procurement and quality procedures—and the opening up of the health sector to unsolicited proposals and unvetted medical supplies—would have dire consequences for the people.
In September and October 2022, the former Health Minister cited insufficient stocks to secure Cabinet approval for emergency medical purchases. Suppliers were selected via expressions of interest (EOI) and unsolicited proposals. A US$ 200 million Indian credit line was available, and the Finance Ministry relaxed procurement guidelines to facilitate emergency buying.
But a technical evaluation committee was not appointed, and the supplies were bought without advanced quality checks, the NAO report states.
Additionally, the National Medicines Regulatory Authority (NMRA) granted waivers of registration (WoR) certificates—which can legally be issued only in specific and crucial circumstances—on an accelerated basis, deviating from the recognised procedure.
“The Chief Executive Officer, instead of following the established procedure of evaluation through a technical evaluation committee, had personally granted approval, thus deviating from the Authority’s primary objective,” the NAO reveals. “Similarly, the Authority had assigned its responsibility for ensuring the quality of medicines to another party.”
The Health Ministry bought hundreds of medicinal drugs through EOIs and 38 through unsolicited proposals (claiming emergency), the NAO says. But when deciding what quantities were required, it disregarded stocks that had already been ordered under normal procedure. This meant certain medicines were received in excess at a time when the country was severely strapped for cash.
While some medicines were bought at “significantly higher prices compared to those purchased through the normal method”, these “emergency stocks” were not received even after drugs bought through normal procedure had arrived.
Some emergency purchases courted worse controversy. This includes human immunoglobulin IV 5-6g which was “observed to be counterfeit”. While the supplier, Isolez Biotech Pharma AG Ltd, claimed to have imported it from India, information from the Import and Export Controller as well as the Department of Customs proved this to be false.
The NAO holds that the “relevant parties failed to fulfil their responsibility for conducting quality testing of medicines before purchasing/providing and distributing them to patients, despite the sensitive nature of these items, which are critical to human life”.
By failing to evaluate and approve registration applications made with the NMRA by medical suppliers within a stipulated period, there arose a shortage of formal suppliers. Consequently, orders were placed with unregistered suppliers with a reliance on WoRs. And evaluations for certain medications were completed swiftly, in less than two days. This was an extraordinary shortening of the evaluation timeframe, the NAO notes.
The report repeats the conclusions of an earlier audit that found that the medical supplies crisis in 2022–23 was due to “the lack of proper management in the health sector, absence of sound coordination between the institutions that carry out related tasks, lack of confirmation that the information necessary to make correct and rational decisions has been provided, and the absence of a proper stock control system”.
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