Private company issued WoR certificates to import 38 medicines without NMRA evaluation in 2022 – COPE reveals

It was revealed in the Committee on Public Enterprises (COPE) that a private company named ‘Savorite’ was issued Waiver of Registration (WoR) certificates to import 38 types of medicines in 2022 without the evaluation of the National Medicines Regulatory Authority (NMRA). 

The former Secretary to the Ministry of Health also informed the Committee that the former Minister of Health had given instructions to select this private company called ‘Savorite’ to import medicines in this way.

This was disclosed when the Committee on Public Enterprises (COPE) of Parliament met in Parliament on Wednesday (March 26), under the chairmanship of Member of Parliament (Dr.) Nishantha Samaraweera, to examine the Auditor General’s reports for the years 2022, 2023 and 2024 and the current performance of the National Medicines Regulatory Authority, the Department of Communication of Parliament said.

The Committee Chair informed the committee that on December 30, 2022, the NMRA had issued Waiver of Registration (WoR) certificates to a private company named ‘Savorite’ for the import of 38 types of medicines submitted through unsolicited proposals without the evaluation of the NMRA. The Committee Chair said that the NMRA has abdicated its responsibility, stating that the purpose of establishing the NMRA is to ensure the quality, safety and efficacy of those medicines and that it cannot be handed over to the Medical Supplies Sector.

Former members of the Board of Directors of the NMRA said that since the import of medicines through a special pathway with prior approval was carried out, the Board of Directors could not grant permission for it without conducting a proper evaluation. Therefore, they said that they did not accept responsibility in this regard.

Accordingly, this matter was discussed at length in the committee, and it was revealed that the former Minister of Health had instructed to select a private company called ‘Savorite’ to import the medicines in short supply for 3 months.

Meanwhile, the Committee also discussed at length the Cabinet Memorandum submitted by the former Minister of Health on 26 September 2022. The Committee Chair inquired from the Ministry of Health officials about the fact that a large number of medicines would reach zero levels within the next 3 weeks from the date of submission of the relevant Cabinet Memorandum. 

The officials who responded said that the information had been added to the Cabinet Memorandum based on the information obtained from the existing database regarding medicines. However, the committee Chair said that it was unacceptable for a large number of medicines to reach zero levels at the same time and that the relevant responsible officials had acted irresponsibly until such a level was reached.

The Auditor General, who spoke at the time, stated that the medicines that were ordered and to be received in advance have also been imported, citing that the medicines have reached zero levels.

Accordingly, the committee chair instructed the officials to submit a full report to the Committee on who were the officials involved in preparing this Cabinet Memorandum. The Chair further stated that a full report regarding the import of these medicines will be prepared by the Committee and submitted to Parliament, and that necessary action will be taken expeditiously.

The Members of Parliament Mano Ganeshan, Nalin Bandara Jayamaha, S. M. Marikkar, Chaminda Wijesiri, Attorney-at-Law Nilanthi Kottahachchi, Chandima Hettiarachchi, Asitha Niroshana Egoda Vithana, Kosala Nuwan Jayaweera, Sudath Balagalla, (Dr.) S. Sri Bavanandarajah, Lieutenant Commander (Retd.) Prageeth Madhuranga and Samanmali Gunasinghe were present in this committee meeting.