The Department of Drug Administration has recalled four medicines manufactured by three Nepali pharmaceutical companies after they were found substandard in laboratory testing.

These medicines, if used by patients, will not cure ailments and rather cause adverse effects, officials at the department, the national drug regulatory body, said.

They, however, concede that the drugs may have already been sold in the market and substandard medicines may have been taken by patients.

“Yes, there is a high chance that the substandard medicines might have already been sold,” said Narayan Dhakal, director general of the department.

“Due to the sluggish testing process in our own labs, it takes a year for results to come out. Samples of the medicines may have been collected a year ago, and the problematic batches may have already been sold.”

According to the department, the CODEP Tablet BP 15, a pain reliever containing codeine phosphate, did not meet the claimed standard. The department directed Lomus Pharmaceuticals Pvt Ltd, the manufacturing company, to halt production and sales of the medicine and to recall it immediately from the market.

Similarly, the Calbone tablet, which contains calcium carbonate IP 250, from batches TCL 203 to TCL 341, manufactured by Curex Pharmaceuticals Pvt Ltd, has been recalled.

The department also ordered immediate recall of EVACIP, eye and ear drop containing ciprofloxacin, batch ECE 140, produced by Everest Parentals Pvt Ltd, and DNS (Dextrose and Sodium Chloride injection), batch A04wz010, produced by Lomus Parentals Pvt Ltd. Both medicines failed sterility tests, meaning they contained microorganisms.

“We have directed the manufacturing company, importers, and distributors to immediately suspend sales, import, and distribution of these medicines, recall them from the market, and inform us,” said Dhakal. “The decision to halt sales and recall these medicines has been taken to ensure patient safety, but again, there are questions about whether the drugs are still in circulation.”

Suspending and recalling substandard drugs is a routine part of the department’s risk reduction measures. Officials said several substandard medicines have also been suspended from sales and distribution or recalled in the past.

However, it is not known whether all those substandard drugs were successfully recalled or if some were sold to patients, as the department does not have the capacity to ensure timely removal of all substandard medicines.

Officials at the department said that due to the slow testing process in the National Medicine Laboratory, patients are often compelled to take substandard medicines. The lab tests around 500 medicines in a year, while over 25,000 brands are sold in the market.

The regulatory agency regularly collects drug samples from pharmacies across the country and tests them in its labs to ensure compliance with quality standards.

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