The National Medicines Regulatory Authority of Sri Lanka finds itself in an unprecedented crisis that poses a significant threat to the well-being of the country’s population. With a lack of confidence in the medicines provided by doctors, both the general public and experts are left bewildered by the series of events unfolding within the authority. To shed light on the situation, Lankasara interviewed Dr. Vijith Gunasekara, the commanding officer of the National Medicines Regulatory Authority, who provided insight into the ongoing crisis and its potential consequences.
According to Dr. Gunasekara, the crisis at the National Medicines Regulatory Authority can be traced back to the implementation of Act No. 5 of 2015, which transformed the former Medicines and Aromatherapy unit into an authority. The recruitment of pharmacist assistants by the authority sparked discontent among pharmacists who demanded additional privileges on par with those provided by the Ministry of Health. However, due to their position of authority, granting such privileges became an impractical proposition. Efforts are currently underway to rectify this situation by conducting proper interviews for authority recruitment.
Dr. Gunasekara acknowledged that it has taken eight years to address this issue, despite previous attempts by the board of directors. Documents have been issued to rectify the situation, and the authority is now actively recruiting through a deadline given to the concerned individuals. Those who fail to comply will be released to the Ministry of Health.
Regarding the salary scales of individuals working between the two organizations, Dr. Gunasekara clarified that the salaries are received from the Ministry of Health, while the authority provides additional allowances and privileges. However, he emphasized that only a few of the pharmacists possess the necessary expertise, and their reluctance to face interviews for recruitment into the authority demonstrates their preference for maintaining the benefits provided by the Ministry.
Addressing allegations of substandard drugs entering Sri Lanka, Dr. Gunasekara dismissed them as baseless and attributed them to disgruntled individuals attempting to discredit the authority. He emphasized the stringent criteria followed in drug registration, including adherence to Good Manufacturing Practice (GMP) standards and rigorous testing conducted by expert committees. Any medicine with potential threats to human life is immediately reported and shared with all countries to ensure patient safety.
While acknowledging past incidents where registered drugs caused harm, Dr. Gunasekara explained that such situations can occur globally, even with drugs approved by expert committees. He stressed that the authority constantly monitors and responds to any quality concerns, ensuring the safety and well-being of patients.
As the National Medicines Regulatory Authority grapples with this crisis, urgent steps are being taken to recruit qualified personnel and establish an efficient task force. The outcome of these efforts will determine the future course of action for the authority, which plays a crucial role in safeguarding public health and well-being.
