-By Special Correspondent
(Lanka-e-News -02.Dec.2024, 11.40 PM) A storm of controversy has engulfed the newly elected National People’s Party (NPP) government as health sector professionals demand an urgent investigation into the importation of 200,000 antigen test kits during the height of the COVID-19 pandemic in 2020. The focus of the probe centers on George Steuart Health (Pvt) Ltd, whose rapid approval to import these kits by the National Medicines Regulatory Authority (NMRA) has raised eyebrows, with allegations of bending established rules.
In 2020, as the COVID-19 pandemic raged globally, countries scrambled to secure critical medical supplies. Among these were antigen test kits, essential for the rapid detection of COVID-19 infections. While the Ministry of Health had invited bids for procurement, George Steuart Health independently imported 200,000 antigen test kits, sparking controversy.
The NMRA granted the company a license on October 22, 2020—barely a month after the World Health Organization (WHO) approved the use of these kits on September 22. The company obtained full import approval within a week, bypassing the standard two-year process outlined in NMRA guidelines.
Under normal circumstances, NMRA regulations require a rigorous multi-step approval process for medical devices. This involves:
Importing Samples: A license must be issued to import samples for evaluation.
Evaluation and Validation: The samples undergo extensive testing, including assessments by external evaluation committees.
Final Approval: Only after satisfying all evaluation criteria is a product allowed to enter the market.
Yet, for George Steuart Health, this process was expedited dramatically. The NMRA cited WHO recommendations to justify this fast-track approval. However, the Ministry of Health reportedly did not issue a validation report for the kits, leaving questions about whether all procedural requirements were met.
Dilith Jayaweera, Chairman of George Steuart Health, dismissed allegations of impropriety, asserting that the transaction was initiated by the private sector in response to urgent needs. He emphasized that the government had no direct involvement in the procurement and accused external entities of politicizing the issue.
“This was a private-sector intervention to address a dire situation. Attempts to link this transaction to the government or the President are misleading and unfounded,” Jayaweera stated during a press briefing.
Former Health Minister Rajitha Senaratne weighed in, defending the NMRA’s decision to rely on WHO recommendations during an emergency. However, he acknowledged procedural discrepancies, pointing out that the validation process remained incomplete.
“The WHO approved these tests on September 22, 2020, and NMRA issued a license by October 22. While the urgency was understandable, the Ministry of Health had not issued a validation report, which was a critical missing step,” Senaratne remarked.
This contradiction fuels concerns among health professionals and watchdog organizations. Why was the usual two-year evaluation process condensed into weeks? Were shortcuts taken at the expense of public health?
The NMRA’s decision has drawn scrutiny for potentially setting a dangerous precedent. If the standard regulatory process can be bypassed during emergencies, critics argue, it opens the door to misuse and exploitation.
Dr. Malini Perera, a senior virologist, stressed the need for due diligence, even in crises. “Emergencies demand swift action, but that doesn’t mean compromising on safety and protocol. These are medical devices affecting millions of lives.”
Similarly, legal experts have questioned the NMRA’s flexibility. According to the country’s regulatory framework, adhering to evaluation timelines is critical to ensure public trust and accountability in healthcare decisions.
Health sector professionals are now pressing the NPP government to initiate a thorough investigation into the importation of these kits. Their demands underscore the importance of transparency in public procurement, especially during health emergencies.
The Medical Professionals Alliance (MPA), a coalition of doctors and health administrators, released a statement calling for stricter oversight. “The public deserves answers. Was the decision to fast-track these imports motivated solely by public health concerns, or were there other interests at play?”
The antigen test kit controversy also highlights broader issues of governance and private-sector involvement in public health. The pandemic exposed gaps in preparedness and procurement processes, forcing governments to rely on private entities.
However, this reliance often comes with its own risks. Without clear accountability, partnerships between the government and private companies can devolve into opaque deals, raising the specter of corruption.
For the NPP, which campaigned on a platform of anti-corruption and good governance, addressing these allegations head-on is critical to maintaining credibility. Any indication of malpractice or undue influence could significantly damage public trust in the new administration.
Independent Investigation: A third-party inquiry into the NMRA’s decision-making process could clarify whether due process was followed and identify any lapses.
Policy Review: Revisiting the NMRA’s emergency approval mechanisms to ensure they balance speed with safety.
Public Disclosure: Releasing all relevant documentation, including communications between George Steuart Health and the NMRA, to enhance transparency.
The antigen test kit controversy is a stark reminder of the challenges faced during the pandemic and the importance of adhering to regulatory standards even in emergencies. As the NPP government settles into office, its response to this issue will serve as a litmus test for its commitment to transparency, accountability, and ethical governance.
The public, still grappling with the aftermath of the pandemic, deserves clarity on whether these kits were a life-saving necessity or a rushed deal that skirted the rules. Only a thorough investigation can uncover the truth, restore confidence in the system, and set a precedent for handling future health crises responsibly.
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by (2024-12-03 00:34:23)
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