A 500mg paracetamol brand ‘Cetophen’ manufactured by Lomus Pharmaceuticals Pvt Ltd has been found substandard in laboratory tests.

Batch CT-2023 of the medicine, which is widely used to reduce pain and fever, failed to meet quality standards, according to the Department of Drug Administration (DDA), the national drug regulator.

“The drug was supplied to the Nepal Army, which sent us samples for quality check,” said Narayan Dhakal, director general of the department. “The drug might have been sent to the market also, so we have directed the manufacturer to recall the medicine and inform us.”

Paracetamol, or acetaminophen, is an over-the-counter drug used worldwide. It is used to treat many conditions—including headache, muscle ache, arthritis, backache, toothache, sore throat, menstrual pain, musculoskeletal pain, cold and fever.

Nepal government has listed paracetamol as an essential drug and provides it free of cost from state-run health facilities across the country. The drug is available in the market under different brand names, with Cetamol, manufactured by the state-owned Nepal Drug Limited, the most commonly available brand.

Paracetamol is among the 96 medicines whose prices were determined by the department some 16 years ago.

The DDA 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.

Dhakal informed that with the latest paracetamol recall, the number of drugs withdrawn from the market since the start of the fiscal year 2023/24 has reached nine.

The department’s report showed that around 11 percent of medicines sold in the last fiscal year across the country have been found substandard in 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 a shortage of staff, they cannot always monitor if all those drugs have been recalled or not.

The department publishes a notice on its website instructing respective companies to recall those drugs at the earliest. But most of the time, those substandard drugs already get sold out by the time the notices are published, as it takes several months for the department to perform tests in its laboratory due to understaffing.