The Committee on Public Enterprises (COPE) has revealed that the National Medicines Regulatory Authority (NMRA) issued Waiver of Registration (WOR) certifications through a special mechanism, bypassing formal committee approval. This disclosure was made during the COPE meeting held in Parliament on March 12, chaired by Hon. Dr. Nishantha Samaraweera, to review the Auditor General’s reports for 2022, 2023, and 2024, as well as NMRA’s current performance.
Discussions highlighted that the WOR certification process allowed the NMRA Chief Executive Officer (CEO) to make unilateral decisions on emergency drug procurement. It was further revealed that in 2022, bulk medicine purchase approvals were sought at an informal dinner event at a prominent Colombo hotel, a move opposed by the NMRA Board of Directors and now under judicial review at the Supreme Court. In response, COPE has summoned the former NMRA Board of Directors for further investigation.
The committee also addressed public health concerns related to unregulated perfumes and creams. Since no institution currently has the legal authority to regulate these products, COPE instructed the Ministry Secretary to initiate legal amendments granting NMRA the necessary powers.
Furthermore, COPE scrutinized the regulation of drug prices, noting that a price control unit was only established in 2022. Officials were directed to resolve existing obstacles and expedite the implementation of a drug pricing formula.
Additionally, COPE raised concerns over inadequate laboratory facilities for testing imported medicines. Despite NMRA’s financial reserves of Rs. 7 billion, post-import drug testing remains a challenge. COPE has now directed the NMRA to allocate funds for establishing a dedicated testing laboratory.
Recognizing inefficiencies in the NMRA Act, COPE urged swift amendments to strengthen regulatory operations. To ensure further oversight, a sub-committee will be appointed, with its members announced in due course.
The meeting was attended by Hon. Members of Parliament M.K.M. Aslam, Samanmali Gunasinghe, Kosala Nuwan Jayaweera, Ruwan Mapalagama, Sunil Rajapaksha, Asitha Niroshana Egoda Vithana, Thilina Samarakoon, and Chandima Hettiarachchi.
