Despite the National Medicines Regulatory Authority (NMRA) having come under intense scrutiny, with approximately 124 patients in various hospitals across the country falling victim to substandard imported medicines last year, no manufacturer has been blacklisted yet, NMRA Chairman Dr. Ananda Wijewickrama reveals.
As per statistics revealed by the Government Medical Officers’ Association (GMOA), the yearly average of such quality failures was at around 70 per year, but had doubled last year alone.
Speaking to The Sunday Morning, Dr. Wijewickrama acknowledged the challenges in testing medicines at every step but expressed hopes of reducing quality failures through random testing this year.
However, he clarified that as of now, no manufacturers had faced blacklisting. Instead, he stressed on the need for procedural refinement, outlining a comprehensive strategy to enhance oversight and fortify medicine quality standards in Sri Lanka.
“From the 124 quality failures in 2023, most were identified after the medicine had gone to the patients. We cannot always test medicines at every step. No country does this; it is difficult even for a country like the US. However, we are hoping to reduce the number of quality failures through random testing this year,” he said.
The NMRA Chairman pointed to the ongoing efforts to formalise the registration process: “We are currently taking steps to formalise the registration process of each medicine, following the standard mechanisms that had not been followed over the last year,” he said.
Furthermore, he highlighted the importance of random post-marketing surveillance as a proactive measure to identify potential issues with medicines already in circulation. However, he also acknowledged a severe staffing issue within the NMRA, which could potentially hinder these surveillance efforts.
In response to the crisis, Association of Health Professionals (AHP) President Ravi Kumudesh criticised the current medicine testing protocols in Sri Lanka, pointing out the lack of random testing or a surveillance process for imported medicines.
Kumudesh outlined a three-step approach to comprehensive medicine testing, calling for testing during the registration process, batch testing before market release, and random sample testing post-distribution within hospitals.
Kumudesh’s critique targeted the current practice of testing primarily during the final stage, with an expert committee controlling medicine imports. He argued that this approach raised valid concerns about the accuracy of testing procedures, evident in the 124 individuals suffering from the consequences of low-quality medicines in 2023.
To address these issues, Kumudesh advocated for the implementation of random batch testing, rigorous testing before importation, and mandatory tests by hospitals and distributors.