No high-quality lab to test drugs for market

Published On: June 8, 2017 05:00 AM NPT By: Bishnu Prasad Aryal

-- Among tested samples, 7 percent do not meet standards
KATHMANDU, June 8: The government has shown gross negligence over the  quality of medicines the public uses. Hundreds of medicines are available in the market, but the government has yet to set up a laboratory to test the quality of the medicines. 

According to the Department of Drug Administration (DDA), more than 15,000 varieties of medicines produced by different manufacturers--about 50 percent domestic products and 50 percent imported-- are available in the Nepal market. The state-owned  National Medicines Laboratory (NML) under DDA, the apex body for drugs management, is not quite up to the task of monitoring quality properly according to officials.

Pharmacies sell whatever medicines they have in stock rather than filling the prescriptions of doctors. They argue that the composition of the drugs is the same and only the company is different.

The government established NML in 2001 to home in on the quality of medicines. Drug testing labs must be of at least BSL (bio-safety level) III standard. However, NML hardly meets the BSL I standard, according to  DDA officials. "Seven percent of samples tested in the laboratory do not meet the quality standards," said a high-ranking official, requesting anonymity.

"Our only drugs lab  in the country [NML] does not have facilities to test the quality of oncological and biological products," said Vabha Rajbhandari, acting director at NML.

"The quality of medicine is  damaged during transportation and storage due to lack of proper handling, packaging, manufacturing process and degradation," she said.

Medicines should be tested at various stages even after these are supplied  to pharmacies, she added.

The quality of allopathic medicines is measured for dissolution, uniformity of contents and impurities while ayurvedic medicines are measured as per microbiological quality, according to the DDA. 

Dr Bishesh Poudyal, a hematologist at the Civil Service Hospital, said  medicines produced by various manufacturers were available in the market but the manufacturers are little known and not so reliable in quality.

"Once someone from the Nepali manufacturers came to me and asked me to prescribe their medicine for cancer. Its cost was Rs 200 per dose while the same dose of the medicine produced in India costs Rs 1,300. When I asked him about the official tests and effectiveness he could not furnish any test result and only said there is no lab in Nepal to test such medicines," Dr Poudyal  said.

The government is yet to set up a lab to test  oncological and biological medicines. At the same time, the country is yet to formulate a generic policy on medicines. Doctors should prescrive only generic medicines. Original and generic medicines are neither produced in the country nor  imported. Patients are compelled to use branded generic medicines, which need to be tested before being released  to the market.

"We attempted to open a high quality lab  two years ago," said Santosh KC, drug administrator at  DDA. "However, no progress has been made due to lack of proper buildings and human resources," he added.

KC claimed that they monitor the batch and documents of  producers though they don't have good lab facilities. "We believe that the manufacturers produce medicines meeting WHO and ISO standards," he said. "However, there is still the problem  of checking the quality of raw materials With regard to the final products, we recall the medicines and dispose of them safely if they do not meet lab tests."

"We are planning to carry out bio-equivalence studies under the Institute of Medicine (IOM)  to regulate the quality of medicines as we need to adhere to the Biopharmaceutics Classification System," said KC. "We will begin to work on this from the coming fiscal year," he added.

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