Two saline solutions have been recalled from the market after lab tests detected the growth of hazardous microorganisms. Doctors say patients exposed to contaminated saline solutions may suffer from septic shock and even die, and the deadly bacteria could spread within hospitals.

“Samples were sent to us by the Seti Provincial Hospital of Sudurpaschim province,” said Narayan Dhakal, director general at the Department of Drug Administration (DDA). “We have instructed agencies concerned to stop using these substandard saline solutions immediately and have ordered companies and dealers to recall products from the market.”

The department, which is the national drug regulatory agency, admitted that testing the contaminated saline solutions took around three months.

“Due to understaffing in our laboratory, it took around three months to carry out the testing,” said Dhakal. “Saline solutions contaminated with hazardous microorganisms should not be used on patients, as this increases the risk of spread of infection and severity. Patients may suffer septic shock.”

The recalled saline solutions are RL 500 ml [Compound Sodium Lactate Injection IP] batch A0581030, and D5% 500 ML batch A0181004, both manufactured by the Nepali pharma company Lomus Parentals and Formulation Pvt Ltd.

In a press statement on Tuesday, the DDA said that RL 500 ml did not meet sterility standards under IP2022, and D5% 500 ml did not comply with USP 2024 sterility test requirements.

Ensuring the quality of medicine in Nepal has long been a challenge, as the drug regulator struggles with limited staff and laboratory capacity, which cause delays in timely tests.

Drug inspectors deployed from the DDA collect samples through random market checks and send them to government labs for testing. If drugs are found to be problematic or substandard, the department directs manufacturing companies to recall those drugs from the market.

However, due to staff shortages, it often takes months for the department to carry out testing. In many cases, substandard drugs are sold and consumed long before tests are compelled and recalls ordered. The department also lacks an effective mechanism to enforce drug recalls.

Experts warn that the use of substandard medicines could seriously harm patients’ health.

DDA officials acknowledge that manufacturers may have supplied substandard batches of saline solutions, which doctors have already used on patients. They also said that they are unaware of the current quantity of substandard saline solutions in the market.

The department publishes recall notices on its website, urging respective companies to recall the drugs immediately. However, most substandard drugs are sold out by the time these notices are published. The department’s report shows that around 11 percent of medicines sold in the last fiscal year across the country were found substandard.

Despite thousands of medicines being sold across the country from both national and international pharma companies, DDA inspectors collect only around 1,000 samples from the market in a year. The inspection work is especially daunting because DDA has only around two dozen drug inspectors tasked with monitoring over 24,000 registered pharmacies and thousands of unregistered ones.

As it takes several months to test some medicines, the department currently allows manufacturing to supply medicines directly from factories.