COPE uncovers irregular NMRA certification process

The Committee on Public Enterprises (COPE) has revealed that the National Medicines Regulatory Authority (NMRA) issued Waiver of Registration (WOR) Certifications through an irregular mechanism, bypassing the formal committee approval process.

The disclosure was made during a COPE meeting held on March 12, chaired by MP Dr. Nishantha Samaraweera, to review the Auditor General’s reports from 2022 to 2024 and assess NMRA’s current performance.

Controversial Certification Process & Judicial Review

During discussions, it was revealed that NMRA had used a fast-track process to approve emergency medical procurements, allowing the CEO at the time to make unilateral decisions. Notably, the approval for a bulk medicine purchase was reportedly sought during a private dinner event at a prominent hotel in Colombo. Doctors on the Board of Directors objected, and the matter is now under review by the Supreme Court.

Given these concerns, COPE has summoned the former NMRA Board of Directors for further investigation.

Need for Regulation of Perfumes & Creams

COPE also highlighted the health risks associated with certain perfumes and creams, stressing that no institution currently holds legal authority to regulate them. The committee instructed the Ministry Secretary to take legal steps to grant NMRA regulatory powers in this area.

Drug Pricing & Testing Concerns

Officials informed COPE that a drug price control unit was only established in 2022 and that regional price comparisons are now conducted. COPE urged authorities to remove obstacles in the drug pricing formula and ensure its full implementation.

Regarding drug safety, officials admitted to issues with laboratory facilities for testing imported medicines. COPE directed NMRA to utilize its Rs. 7 billion financial reserve to establish a post-import drug testing laboratory.

Legal Reforms & Sub-Committee Formation

COPE emphasized the need to strengthen the NMRA Act to enhance efficiency and announced plans to form a sub-committee for further investigations. The names of its members will be announced soon.

The meeting was attended by MPs M.K.M. Aslam, Samanmali Gunasinghe, Kosala Nuwan Jayaweera, Ruwan Mapalagama, Sunil Rajapaksha, Asitha Niroshana Egoda Vithana, Thilina Samarakoon, and Chandima Hettiarachchi.

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