The National Medicines Regulatory Authority (NMRA) issued a total of 286 Waiver of Registration (WOR) letters on behalf of the State Pharmaceuticals Corporation (SPC) and the Medical Supplies Division (MSD) in the previous year alone, the National Audit Office (NAO) reveals.
In its recent audit report on the NMRA, the NAO has uncovered a concerning lapse in oversight.
The report revealed that during the inspection of 38 WOR certificates issued to a private company, the NMRA had failed to evaluate the relevant medicines. Consequently, the authority had disclaimed responsibility for ensuring the quality, safety, and efficacy of these medicines. The NAO contended that the Director of the MSD should assume responsibility, emphasising that the NMRA’s abdication of responsibility had become a contentious point in the audit.
NMRA process
In accordance with Sections 58, 59, 82, 83, and 109 of the NMRA Act No.5 of 2015, the manufacture or importation of any medicine or medical device is strictly regulated. It mandates that such products must undergo registration with the authority and obtain a licence before being manufactured or imported.
According to Section 109 of the NMRA Act, the authority is granted the discretion to permit the importation and supply of specific medicines, medical devices, or borderline products under exceptional circumstances. These circumstances include situations aimed at preserving lives, controlling infectious outbreaks or epidemics, or addressing national emergencies and security concerns.
The granting of such permission can be initiated either through a formal request from the Ministry of Health or, alternatively, through a request made by an individual or organisation recommended by the Ministry of Health.
Notably, the importer assumes a significant level of responsibility, being accountable for the proper management of the imported products. Additionally, the importer is obligated to submit routine reports to the authority, ensuring ongoing oversight and compliance with regulatory standards for the imported medicine, medical device, or borderline product as stipulated by this section.
Section 58(1) of the NMRA Act explicitly prohibits the manufacture or import of any medicine without the mandatory registration with the authority and the acquisition of a corresponding licence.
Furthermore, Section 59 details the procedural requirements for individuals or entities intending to engage in the manufacturing or importing of medicines. Applicants must submit a formal application for the registration of the intended medicine, utilising the prescribed form and including requisite particulars, samples of the medicine, and the designated fee. The authority diligently maintains a comprehensive register documenting each application received for medicine registration, recording prescribed particulars as specified.
Upon receiving an application, the authority promptly forwards it, along with the accompanying sample and particulars, to both the Medicines Evaluation Committee (MEC) for evaluation and consideration of healthcare relevance, safety, efficacy, and affordability, and to the National Medicines Quality Assurance Laboratory (NMQAL) for rigorous testing of the medicine’s quality.
The authority is obligated to communicate the receipt and submission of the application for evaluation and testing to the applicant through written notification. This rigorous process underscores the commitment to ensuring the availability of safe, effective, and high-quality medicines that align with public healthcare needs at an affordable cost.
NMRA response
The NMRA, in response to the NAO and as detailed in the audit report, has clarified that the issuance of WOR letters occurs under specific circumstances, primarily based on recommendations from the Ministry of Health.
The NMRA has acknowledged that pharmaceutical companies may not find it economically viable to register medicines with low commercial benefits. Consequently, a system is deemed essential to facilitate the importation of these medicines when patient needs necessitate them. This perspective emphasises the imperative of balancing accessibility with commercial considerations.
Furthermore, the NMRA underscores that in instances where other regulatory authorities have granted clearance for unregistered medicines and such medicines are imported under the WOR framework, the responsibility for ensuring the quality, safety, and efficacy of these medicines does not lie with the NMRA.
The NAO has recommended minimising the entry of uncertified medicines into the country by advocating the issuance of a WOR only in specific cases explicitly outlined in the governing act.
Significant financial discrepancy
Furthermore, the NAO has brought to light a significant financial discrepancy related to the issuance of WORs for private supplies of medicines, medical equipment, and borderline products.
According to Fee Orders No.2, 3, and 4 of Special Gazette No. 2052/33 dated 5 January 2018, fees are stipulated for WOR applications in the private sector. However, NAO findings indicate that the authority incurred a substantial loss of Rs. 10,686,209. This loss corresponds to fees that could have been charged for 123 applications for a WOR for medical devices in the private sector.
Astonishingly, these applications were rejected during the reviewed period due to the non-implementation of fees in the approval process for a WOR.
It is disclosed that, despite the issuance of an internal circular on 25 January 2023 aimed at rectifying this financial lapse, no consequential action was taken in accordance with Finance Regulation 128(j).
This regulation pertains to addressing financial irregularities and specifies measures that can be taken against officers responsible for any significant revenue loss incurred by the Government.
According to statements provided by the NMRA and documented by the NAO, it is clarified that the procedures for applications for exemption from registration were in place even before the release of the gazette dated 5 January 2018.
The NMRA has asserted that the continuation of the same method utilised by the preceding institution for handling these exemption applications was not a deliberate attempt to circumvent the gazette. This clarification suggests that the NMRA had pre-existing processes in operation, and any perceived misalignment with the gazette may have been a result of established practices rather than a deliberate effort to contravene regulations.
Moreover, it is noted that, upon the identification of the issue’s severity during the audit, corrective actions were taken. Specifically, following the internal circular dated 5 January 2023 and Gazette No. 2052/33 dated 5 January 2018, the NMRA adjusted its approach. Notably, fees are now charged when applying for private sector supplies after the approval for public sector supplies.
The NAO has highlighted the significance of accountability in the face of the substantial revenue loss incurred by the Government. In light of this, the NAO has recommended that officials responsible for this financial shortfall should be addressed under Finance Regulation 128(j).
A suffering country
Speaking to The Sunday Morning, Government Medical Officers’ Association (GMOA) Spokesman Dr. Chamil Wijesinghe said: “The country suffers significant financial losses each year due to emergency purchases, leading to the acquisition of medications of inferior quality at higher costs.”
Highlighting the risks associated with emergency purchases, including corruption and concerns about product quality, particularly through the use of WORs, Dr. Wijesinghe revealed: “Last year alone, the NMRA issued WORs on approximately 750 instances, and by the end of July this year, the number had reached 500 instances.”
Dr. Wijesinghe also pointed out the substantial markup on medicines acquired through emergency purchases, often reaching three to four times the original price.
He said there was an urgent need to address this issue and promote a more financially-responsible and transparent procurement process within the healthcare sector.
Meanwhile, Academy of Health Professionals (AHP) President Ravi Kumudesh expressed concerns about the apparent discrepancy between existing rules and regulations and their actual implementation within the Health Ministry.
“Tenders for essential medical supplies frequently experience delays due to various reasons. These delays can extend the procurement process up to six months or more. Such prolonged timelines can lead to genuine shortages and potentially emergent situations,” he stressed.
“The Health Ministry must reevaluate and expedite its procurement procedures, especially in critical situations where timely acquisition of medical supplies is essential for public health and safety,” Kumudesh said.