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Pharmaceutical quality testing: Feasibility study launched for lab

Pharmaceutical quality testing: Feasibility study launched for lab

16 Jul 2023 | By Maheesha Mudugamuwa

  • No decision on whether to set up new lab or upgrade existing one
  • An accredited lab costs around Rs. 1 billion: Rambukwella 

The Government is taking initial steps to establish an internationally-accepted and accredited laboratory to conduct quality tests of medicines that are imported to the country, according to Health Minister Keheliya Rambukwella.

Minister Rambukwella, who has recently come under strong criticism by medical practitioners and the public for the state of the health sector, told The Sunday Morning that it would cost around Rs. 1 billion to establish an accredited lab and that the initial feasibility study was being carried out by a Standing Cabinet-Appointed Procurement Committee (SCAPE).

According to the Minister, no final decision has been taken as to whether a new lab would be established or if the existing lab at the National Medicines Regulatory Authority (NMRA) can be upgraded to international standards.

Sri Lanka has no standard laboratory to test the quality of medicines that are imported to the country despite the State spending billions of rupees each year to do so.

As learnt by The Sunday Morning, the only laboratory at the NMRA was designed 30 years ago and is now said to be in a dilapidated condition, with a number of instruments and equipment out of operation.

It is also learnt that the lab had only submitted the documents to obtain standard certifications from the International Organisation for Standardisation (ISO), which too had been rejected as the ISO had requested to make a number of changes to the entire laboratory so as to enable it to be reviewed for standardisation.

Speaking to The Sunday Morning, Association of Health Professionals (AHP) President Ravi Kumudesh stressed that nearly 50% of the machines at the NMRA laboratory were not in working condition and that there was an out-of-order notice on most machines.

“Any regulatory company in the world has to have an independent laboratory. In Sri Lanka too, when the NMRA was established, a lab named NDQL was established in 1990. However, these tests are not being done at this lab. Its capacity has not been improved since inception and it is currently in a dilapidated condition,” he said, adding that the number of scientists at the lab has now dropped to around 20 from 60 two years ago.



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