Lack of advanced lab leads to influx of low-quality drugs : Experts

• Regulatory mechanism not functioning
• Experts call for revamping entire regulatory system of drugs
• NMRA too in position to develop fully-equipped lab

 By Sheain Fernandopulle

The absence of an advanced laboratory to test the quality of pharmaceuticals has resulted in an influx of drugs of inferior quality in the market, leading to fatalities of patients at times, medical experts alleged.

Speaking to Daily Mirror, Secretary of the Government Medical Officers’ Association (GMOA) Dr. Haritha Aluthge said Sri Lanka lacks a proper mechanism of regulating the quality of drugs, mostly imported from India.
“That’s why we have been urging the Health Ministry to establish an advanced laboratory with WHO accreditation to test the quality of all batches of drugs coming to the country. What is happening is that the quality of drugs is checked through the patients, which could result in deaths and complications as evident by the recent incidents,” Dr Aluthge said.

“We urge the Government to take prompt measures to set the tone to establish a quality assurance laboratory in collaboration with a suitable foreign body,” he added.

Dr. Aluthge said that a spate of unregistered drugs had entered the country under the emergency purchase, leading to serious concerns among medical professionals.

Commenting on the matter, President of the Sri Lanka Medical Association (SLMA), Dr. Vinya Ariyaratne told Daily Mirror that “Irrespective of the origin of the country, there is an independent mechanism of evaluating and improving drugs. Our concern is that National Medicines Regulatory Authority (NMRA) has failed to effectively manage the due process resulting in a serious breach of confidence among doctors and people on the quality of drugs.”

“We have also noticed that several drugs are being imported by means of a provision called waiver of registration (WOR), which facilitates the import of specific drugs on an emergency basis. However, the NMRA has violated that process as well, leading to grave concerns with regard to the quality of certain drugs,” he argued.
“In this manner, it is evident that the regulatory mechanism of drugs is not functioning properly and there is an immediate need to have a comprehensive analysis as to how a sound testing on the drugs can be conducted,” Dr Ariyaratne added.

A senior official from the NMRA told Daily Mirror that there is an immediate necessity of establishing an advanced laboratory where almost all batches of drugs could be tested in order to ensure the quality of drugs.        

• several drugs are being imported by means of a provision called waiver of registration