Three injectable medicines being sold in the country found substandardThe national drug regulatory body says the substandard medicines could jeopardise patients’ lives.
Three injectable medicines—two types of saline and pantoprazole sodium, which are available in the market and are being used on patients—have been found to be substandard in the laboratory tests.
According to the Department of Drug Administration, the national drug regulatory body, which has carried out testing in its own laboratory, the substandard drugs are not safe to use and could risk patients’ lives if used.
“We have already directed respective manufacturing companies to recall the substandard drugs immediately from the market and inform us,” said Narayan Prasad Dhakal, director general of the department. “Patients on which the said medicines are used could suffer from fever and many other conditions, which could often be life-threatening.”
Of the three medicines recalled by the department, two, sodium chloride solution and ringer lactate solution for injection batched A03WY 245, were manufactured by Nepali pharmaceutical company Lomus Parentals and Formulation Pvt Ltd, and pantoprazole sodium batched N162206 was manufactured by Indian company Anglomed Ltd.
The DDA said that the substandard medicines of the said batches, manufactured by Lomus Parentals and Formulation Pvt Ltd, did not comply with Indian Pharmacopoeia 2022 with respect to particulate matter and endotoxin tests. Likewise, the Indian company’s medicine did not comply with analytical method validation protocol with respect to the sterility test.
“With these three medicines recalled, the number of medicines recalled in the ongoing fiscal year reached eight,” Dhakal said. “Recalling substandard drugs from the market is our regular work and among the risk reduction measures.”
In Ashoj, the department recalled from the market five medicines that were found substandard in the laboratory testing.
The regulatory agency regularly collects drugs through random sampling methods from pharmacies across the country and tests in its own laboratory to examine if the medicines being sold in markets comply with quality standards.
The department’s own report showed that around 11 percent of medicines sold in the last fiscal year across the country have been found substandard in the laboratory examinations. Officials had directed the respective manufacturing companies to recall those drugs from the market.
However, it is not known if all those substandard drugs were recalled or sold to patients, as the department does not have the capacity to ensure all substandard medicines are recalled on time.
The DDA officials admit that due to understaffing, they cannot always monitor if all those drugs were recalled or not.
The department publishes a notice on its website asking respective companies to recall those drugs at the earliest. But most of the time, those substandard drugs get sold out at the time the notices get published, as it takes months for the department to perform tests in its laboratory due to understaffing.