News
Ministry withholds India-made dialysis mini caps after detection of fungus
The Health Ministry has withheld a batch of mini caps–a medical device used in a type of dialysis carried out through the abdomen lining–following the detection of fungi in an unused sample and after hospitals reported a high number of peritonitis, or inflammation, episodes among patients.
The suspect batch was part of a large US$ 150,650 (Rs. 48.6mn) consignment imported under the Indian line of credit on a “waiver of registration” granted by the National Medicines Regulatory Authority (NMRA). This allowed the supplier to bypass stringent quality, safety and efficacy checks.
The order was placed with India’s St. Stone Medical Device (Pvt.) Ltd. as an emergency purchase in November last year. As of June this year, however, the Ministry’s Medical Supplies Division (MSD) was still in possession of a large, unused quantity of leftover stock from a different supplier.
“The emergency purchase was done without even distributing the remaining stock to hospitals,” a senior hospital administrator pointed out. “If there were adequate quantities, what was the need to go for an emergency purchase bypassing prescribed tender procedure and regulatory oversight?”
The “mini caps (one for each CAPD, or continuous ambulatory peritoneal dialysis, bag)” are used in peritoneal dialysis. The withheld batch was manufactured in October last year and has an expiry date of September 2024.
WoRs, which are only permitted by law under exceptional circumstances, have now become routine and pose a heightened risk to public health, medical and pharmaceutical professionals warn. The waivers are sanctioned at the highest levels of the Health Ministry. Health Ministry officials claim that some medicines and devices are purchased on WoRs to meet urgent shortages in Government hospitals. However, documents received by the Sunday Times show that 150,916 mini caps were available at the MSD as of June but not distributed.
The MSD published a long list of surgical items that it had in reserve and were due to expire in 2023-2024. There were “large available stocks” sufficient for more than 12 months, it said.
One of these items was mini caps, manufactured in Ireland for Baxter Healthcare, an American multinational company specialising in products to treat kidney disease. It was not clear whether the listed mini caps were bought or donated to Sri Lanka.
Sri Lanka’s order for 1.2 million additional mini caps from India’s St. Stone received approval from the Indian High Commission in Colombo in November last year; of this, 500,000 were required to be delivered immediately. The purchases are funded through an Indian loan which must be repaid with interest.
Complaints were subsequently received from, among others, the Anuradhapura and Kandy Teaching Hospitals regarding the presence of fungus in the mini caps as well as negative reactions in peritoneal dialysis patients. In Anuradhapura, it was nurses who raised the alarm and requested a replacement for the product they had been issued.
On July 5, this year, the NMRA’s Medical Devices Evaluation Committee recommended that the suspect batch be withheld immediately, pending further tests.
The Health Ministry has still not ordered an independent investigation into continuing, serious issues related to the drugs and devices it purchased–predominantly under the Indian line of credit– by waiving domestic regulatory oversight citing an “emergency” that does not appear to end.
Instead, Health Minister Keheliya Rambukwella appointed a seven-member committee to inquire exclusively into recent drug allergies. The committee found that out of 15 cases referred to it, only two deaths were related to allergies. There was no probe into the remaining incidents.
The full report was not released. But the recommendations–which were made public–included a call for a stringent evaluation of the quality of medicines during registration, post-marketing quality testing of random samples; and appropriate and expedited reporting on quality failures.
It also called for “speedy remedial actions on procedural and/or financial issues that may hinder the adequate supply of safe and effective drugs of acceptable quality to healthcare institutions” and urged strict maintenance of temperature control during the transportation of pharmaceuticals.
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