Kathmandu: In a bid to ensure the quality of medicines being prescribed to patients, the Department of Drug Administration (DDA) has been preparing to carry out on-site tests of medicines.
For that the national drugs regulatory body has imparted training to its 28 drugs inspectors and technicians, who will be deployed to hospitals across the country.
“A four-day field-based screening training for drug inspectors has been completed today,” said DDA Director General Narayan Prasad Dhakal. “Our drug inspectors carried out testing of drugs at Bir Hospital as a demonstration on Tuesday.”
Officials at the department said many countries have been practicing drug testing outside the laboratory, which gives immediate results within minutes of the collection of samples. The US Agency for International Development (USAID) has provided technical as well as financial support to carry out field based screening training.
Officials said that basic qualities of the drugs—identification, disintegration, visual inspection for cracks, splitting, capping and cavitation, as well as contamination, foreign matter, presence of empty capsule, stickiness, color and odor of the solution, taste of liquid, labeling, brand name, generic name, among others, will be examined during on-site testing.
During demonstration testing carried out at Bir hospital on Tuesday, metronidazole of three different companies—two Nepali companies and one of Indian companies were examined. Officials said that they did not find any problems in the medicine samples collected randomly from pharmacies operating near the hospital.
Ensuring quality of medicine in Nepal has always become an issue, as the national drug regulatory body struggles with a shortage of staff, and its laboratory doesn’t have capacity to carry out testing on time.
Drug inspectors deployed from the DDA collect drugs through the random sampling methods and send them for testing in the government’s laboratory. If drugs are found problematic or substandard, the department directs the manufacturing companies concerned to recall those drugs from the market. However, the department does not have an effective mechanism to ensure the recall.
In most cases, delays in testing at the laboratory mean that results come in only after all the substandard drugs have been sold in the market.
Experts say the use of substandard medicines could adversely affect the patients’ health.
While thousands of medicines manufactured by national as well as international pharma companies and are being sold from pharmacies across the country, DDA inspectors collect only around 1,000 samples from the market in a year. The inspection work is especially daunting because DDA has just around two dozen drug inspectors tasked with monitoring over 21,000 registered pharmacies and thousands of others unregistered pharmacies.
And it takes several months to examine some medicines as the DDA’s laboratory is understaffed with several posts for technicians remaining vacant. The department allows the drug manufacturing companies to supply medicines into the market directly from the factory.
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