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Jayasumana-appointed committee proposes NMRA be brought under Jayasumana
View(s):A five-member committee appointed by Pharmaceuticals Regulation State Minister Channa Jayasumana to probe the activities of the National Medicines Regulatory Authority (NMRA) has recommended that the State Minister himself be given full control of the NMRA.
The NMRA is currently under Health Minister Keheliya Rambukwella.
The hand-picked committee in its interim report has cited inconsistencies in gazette notifications, pointing out that the English version of the gazette clearly explains the subjects and functions, but the Sinhala version has certain omissions that raise legal issues for the state minister to perform his duties. The report points out that in the event of inconsistencies in the English and Sinhala gazettes, the Sinhala version would prevail. Accordingly, it has recommended that the Sinhala version of the gazette be amended to address these inconsistencies
The report also highlights that the state minister must carry out his duties as per the said gazette subject to the NMRA Act No.05 of 2015. However, Section 146 of this Act interprets the “Minister” as the minister who has been assigned the subject of health while the “Ministry” is interpreted as being the Ministry of Health.
“Therefore, though the gazette has assigned certain subjects and functions related to the NMRA under the State Minister, as the “Minister” and “Ministry” are interpreted as the “Health Minister” and the “Health Ministry,” a situation has been created where the State Minister must conduct all his activities through the Health Minister and the Health Ministry. It is inevitable that this will create conflicts both in terms of the law and between the two parties,” the report observes.
The five member committee comprises retired High Court Judge Kusala Sarojini Weerawardena (Chairperson), Prof. Manik Hettihewa, Dr. Udaya Sri Kariyawasam, A.H. Gamage and Dr. Prasad Colombage.
State Minister Jayasumana appointed the committee in the aftermath of the incident where terabytes of information were allegedly and deliberately erased from the e-NMRA digital database.
The committee has also noted that of the 102 complaints and suggestions it received, more than 75 related to issues concerning the e-NMRA digital database. These included complaints that though online applications had been submitted to register medicines and medical equipment after paying a high fee, applicants had to spend a long time waiting to obtain their registration certificates. Applicants had also complained that they have no way of knowing what was happening to their applications and that there was no transparency.
As such, the committee has recommended that the NMRA immediately set up a more effective, transparent and customer friendly system to submit such applications.
Among other matters, the committee has recommended that steps be taken to rectify deficiencies within the administrative structure of the NMRA without delay. To do this, it has recommended that the NMRA Act be amended so that the State Minister is given powers to make these necessary administrative changes.