A recent Committee on Public Enterprises (COPE) session exposed serious irregularities in the importation of medicines, particularly regarding drugs brought into the country outside the standard procurement process.
Officials from the National Medicines Regulatory Authority (NMRA) were summoned to clarify concerns about the Waiver of Registration (W.O.R.) list and its lack of transparency.
Key Issues Highlighted:
- Missing Technical Documents – COPE Chairman Nishantha Samaraweera questioned the removal of medicines from the W.O.R. list and emphasized the need for transparency. NMRA Chairman Dr. Ananda Wijewikrama admitted that while some documents were available, purchase orders and technical evaluations were missing, raising concerns about medicine quality. NMRA CEO Dr. Savin Semage confirmed that no technical documents were reviewed.
- Lack of Transparency in Decision-Making – Director General of Health Services Dr. Asela Gunawarden stated he had concerns about board meetings’ transparency and refused to attend. He later received a file related to a special case, which he reviewed and recommended rejecting due to missing documents.
- Unusual Board Meeting at a Hotel – Dr. Pradeep Kumarasinghe de Silva revealed that a last-minute board meeting was arranged at a hotel during a staff dinner, where a large number of drugs were approved without proper discussion. He opposed the approvals, stating that an advance of Rs. 100,000/- was taken for the meeting but later returned, indicating no valid board meeting took place. The Auditor General questioned the legitimacy of the meeting and whether a proper quorum was met.
- Approval of Unverified Medicines – Prof. Priyadarshini Galappatti highlighted that around 300 medicines were presented for approval without going through the W.O.R. committee. Some of these medicines were sourced from blacklisted companies, raising serious concerns about the safety and credibility of imports.
The COPE investigation raises critical concerns about the NMRA’s oversight, transparency, and the influence of external parties in the medicine importation process. Further inquiries are expected to determine the extent of these irregularities and prevent potential risks to public health.
