Of the more than 24,000 types of medicines—both allopathic and ayurvedic—available in the Nepali market and manufactured by national and foreign companies, quality testing was carried out on only 648 in 2025.

Inspectors from the Department of Drug Administration collected samples of over 1,200 medicines, but the National Medicine Laboratory under the department could test only a fraction due to resource constraints.

Experts are concerned that lab reports on most of the medicines collected for testing were submitted almost a year after production, by which time many may have already been sold or used, including substandard ones.

A few days ago, the department, which is also the national regulator of medicines, recalled a third-generation antibiotic, Levoflox-500 tablet, after the medicine was found substandard in laboratory testing.

The medicine’s batch, BB24001, manufactured by Bara-based Magnus Pharma Pvt Ltd failed to meet IP 2022 standards in the dissolution test, according to the department. Officials acknowledge that the medicine samples were collected a year ago and are unsure whether the medicines are still available in the market.

“Sometimes, suspected substandard medicines before testing can even be completed,” said Bharat Bhattarai, director at the laboratory. “We have our own limitations, including budget, human resource, and technology.”

Officials said eight lab technicians conduct testing, and not everyone can test every medicine, as they are specialised in a specific sector.

“There are 220 working days in a year. How many tests can eight technicians realistically perform, especially when some take leave?” questioned Bhattarai. “And we don’t even have sufficient budget to procure reference standards, which are costly.”

Reference standard is a certified pure sample of a drug used as a benchmark to test the quality and strength of other medicine batches. So if inspectors are testing hundreds of medicines, the lab would need multiple reference standards, one for each active ingredient or formulation.

According to officials, each reference standard costs up to Rs200,000, and the laboratory has been provided only Rs800,000 in the current fiscal year.

Without sufficient reference standards, hundreds of medicines cannot be tested accurately, officials said.

Earlier, the US government provided a grant of Rs50 million per year through USAID to purchase reference standards, but with the USAID shutdown, the laboratory has been struggling to arrange reference standards.

Officials admitted that underperformance of the laboratory has prevented them from removing substandard medicines from the market on time.

“The laboratory used to test over 1,000 medicines in a year,” said Narayan Dhakal, director general of the drug regulator. “Testing has now dropped to nearly half, and reports come a year after samples are collected. By the time the report is issued, some medicines are already sold.”

DDA officials said that due to understaffing, they cannot always monitor if all recalled drugs have been removed from the market. They said that around 20 drug inspectors are responsible for inspecting around 25,000 pharmacies operating across the country.

Apart from this, DDA inspectors also have to carry out inspections of national and international drug laboratories supplying medicines in Nepal.

Officials say that they will seek an investigation report from Magnus Pharma Pvt Ltd regarding the failure of the medicine in the quality test and the status of the recalled batch.

Experts say that delays of months or years in reporting substandard medicines directly endangers patients’ health and term it sheer negligence on the part of the government.

“If patients take substandard medicines, their health could be at serious risk,” said a former DDA official, asking not to be named. “Lack of quality medicines can worsen patients’ health conditions, and in some cases, even lead to death.”