NMRA’s WoR issued through a special procedure sans formal approval!
The Committee on Public Enterprises (COPE) disclosed that the Waiver of Registration (WOR) Certification by the National Medicines Regulatory Authority (NMRA) had been issued through a special mechanism without the approval of the formal committee.This was disclosed during the recent (12) meeting of the Committee on Public Enterprises (COPE) held in Parliament, chaired by MP Dr. Nishantha Samaraweera.
The meeting was held to review the Auditor General’s reports for the years 2022, 2023, 2024 and current performance of the NMRA.During the meeting, extensive discussions took place regarding the intervention of the NMRA in the emergency procurement of medicines. It was disclosed that the WOR certification had been issued through a special pathway, bypassing the formal committee approval process, utilizing a fast-track mechanism. This process has thus allowed the Chief Executive Officer to make unilateral decisions regarding emergency purchases. It was further disclosed that the Chief Executive Officer who held office in 2022 was involved in this special mechanism and that approval for the bulk purchase of medicines was sought during a dinner event held at a prominent hotel in Colombo. However, the doctors representing the Board of Directors opposed this move, and the matter is currently under judicial review in the Supreme Court.
Following discussions at length, COPE decided to call the former Board of Directors of the NMRA holding office during the relevant period before the Committee for further investigation. Additionally, the COPE highlighted the need to regulate the use of perfumes and creams due to the health issues associated with them. However, it was disclosed that no institution has legal authority in this regard. The officials present pointed out that the necessary legal provisions should be made in this regard and their institution should be given authority. Accordingly, the COPE instructed the Secretary to the Ministry to take the necessary legal steps to provide the NMRA with the required authority.
The committee also discussed the regulation of drug prices. Officials stated that there was no price control unit until 2022, however, a unit was established the same year and drug price comparisons are thus conducted regionally. COPE instructed the officials to remove the existing obstacles related to the drug pricing formula and implement it without delay.When questioned about the inspection of imported drugs, the officials disclosed that there was an issue with laboratory facilities for testing. Upon inquiry about the NMRA’s financial reserves, the officials stated that there was a reserve of Rs. 7 billion. COPE directed the NMRA to utilize these funds to establish a laboratory for post-import testing of drugs.
Furthermore, COPE instructed the NMRA to promptly address the weaknesses in the existing NMRA Act to facilitate efficient operations. In addition, the COPE Chair stated that a sub-committee would be established to further investigate the NMRA. The names of the members of this sub-committee will be announced in due course.
