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Chronic delays in registering drugs; NMRA says it suffers from staff shortage
View(s):The National Medicines Regulatory Authority (NMRA) this week admitted to chronic delays in registering locally manufactured and imported pharmaceuticals blaming it on staff shortage.
The State Pharmaceutical Corporation (SPC) has now offered to step in and help clear the backlog of hundreds of applications pending registration, some almost a year.
NMRA Director General/Chief Executive Officer Dr. Kamal Jayasinghe said the NMRA was under-staffed and was waiting for the Management Services Department to approve the scheme of recruitment.
“Once approved we plan to increase the cadre from the present 23 to 70. We have already selected the pharmacy graduates to be recruited. Registrations can be accelerated and the COVID triggered backlog can be cleared,” he said.
The SPC has now written to pharmaceutical companies seeking a list of pending registrations so that it can intervene in registering hundreds of medicinal drugs with the NMRA.
In a letter to heads of Sri Lanka Chamber of the Pharmaceutical Industry, Sri Lanka Chamber of Medical Devices Industry and Sri Lanka Pharmaceutical Manufacturer’s Association, SPC Chairman Dr. Prasanna Gunasena states that a number of products are not registered with the NMRA.
Among the medication included in the pending list are chemotherapy medications, medication used to treat fluid buildup due to heart failure, tuberculosis, anti-malaria, to treat sickle cell disease, leukemia, epilepsy, HIV/AIDS, immunosuppressive disease, liver scarring or kidney failure, psychiatric illnesses, to prevent seizures in severe pre-eclampsia.
“The SPC faces problems when it is unable to call for tenders if the drugs are not registered,” said Dr. Jayasinghe.
Sri Lanka Chamber of the Pharmaceutical Industry President Kasturi Chellaraja Wilson said member companies complained over delays and even for tender purposes the drugs needed to be registered.
Another pharmaceutical importer said they had been waiting for months to get some drugs registered.
“Prior to the pandemic situation it took about four to eight months to register imported pharmaceuticals. Even when it comes to pricing, NMRA approval is needed. This cannot be a slow process, now that online registration has begun,” he said.