News
NMRA admits quality failures of some imported drugs with registration waivers
View(s):The National Medicines Regulatory Authority (NMRA) revealed this week that some products for which it granted “waivers of registration” (WoRs) had, after import and use, failed quality tests.
These are “bupivacaine hydrochloride in dextrose injection USP 5mg/ml” and “propofol injection 500 mg/50 ml—both of which the Sunday Times previously reported on.
The others are “prednisolone acetate ophthalmic suspension USP 1% w.v. liquid” (registration valid till 2027); “co-amoxiclav for injection BP 1.2g” (registration valid till 2023); and “ceftriaxone for injection USP 1g” (registration valid till 2028).
In a media statement signed by its chairman, Prof. S. D. Jayaratne, the regulator outlined issues related to all six drugs. The National Eye Hospital and the Nuwara Eliya Government District General Hospital reported cases of endophthalmitis (inflammation) after the use of the relevant prednisolone medication. It was withdrawn after samples failed “sterility tests” at the NMRA laboratory.
Several hospitals reported adverse reactions—fever, rigours and shivering—to the propofol injection bought under the Indian credit line on a Health Ministry request. A batch was withheld on May 29. Other batches were also suspended after more reports came in.
Samples from the Matara District Hospital, the District Base Hospital Teldeniya and other hospitals were sent to the lab and failed quality tests. They were found not to conform to the required standards. One batch was withdrawn while the manufacturer recalled the rest.
The suspect bupivacaine injection was registered in 2018, but the relevant company did not renew the permit. It was imported under the Indian credit line. After the Peradeniya Teaching Hospital reported the death of a pregnant woman, samples were sent to the lab. Two batches failed quality tests; one passed. In July, the NMRA withdrew the product based on lab reports.
Several hospitals countrywide reported a serious allergic reaction (anaphylaxis) to the suspect co-amoxiclav batches, including three deaths at the Nikaweratiya Base Hospital and incidents at the Ragama Teaching Hospital, the Karanawella and Wathupitiwala hospitals and the Gampaha District Hospital. Samples have been sent to a World Health Organisation prequalified lab for further testing. One batch was withdrawn on the basis of a national lab report.
The questionable ceftriaxone was linked to a patient suffering anaphylaxis at the Peradeniya Teaching Hospital. Samples have been sent for testing to the NMRA quality assurance laboratory and a report is due. The batches are withheld on Health Ministry advice.
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