The College of Medical Laboratory Science Sri Lanka (CMLSSL) called on the Government to streamline and refrain from making “political appointments,” to the two top positions of the National Medicines Regulatory Authority (NMRA) in the future.

CMLSSL President, Ravi Kumudesh, responding to a release by the NMRA, said no one would benefit if the NMRA took submissions and criticism against it personally. The country and the health service would benefit only if the Authority acted with efficiency and independently. “Therefore, it was in the best interest of the institution itself if the Authorities Chairman and CEO did not block the appointment of two more suitable regulators to the positions following a system that was politically independent.” Speaking on the letter to the duo, he said it was their responsibility at the moment to support the transformation of the organisation into one that was sensitive to the issues facing the country. 

“With past experience, it is your responsibility at this juncture to add your support towards the transformation of the NMRA into an institution that is sensitive to the health issues facing the country,” he said. Having critiqued the Authority even before their appointment, it should be understood that the NMRA was responsible for the health problem facing Sri Lanka. It is the only, revenue-generating and earning institution within the Health Ministry. Therefore, it cannot be compared with the service rendered to its clients with that of a hospital, the Health Ministry, or that of any other institution under it. He said providing an efficient service to the satisfaction of its clients should not be taken as giving its approval to substandard drugs or allowing the mafia to have its way.

“We accept the fact that the NMRA should be more independent than the Director General of Health Services (DGHS) or the Health Ministry, but such independence cannot be maintained by officials, who are appointed to these key positions solely on the basis of personal affiliation, without any structural examination of experience or ability,” he pointed out. The criticism of the CMLSSL shows no personal vendetta nor did it underestimate the commitment of any of the staff working in the Authority.

“The CEO and the Chairman of the NMRA are directly responsible for the accusations levelled against them. Although they had assumed highly responsible positions only due to their political affiliations, the country as a whole is suffering due to the setbacks caused by delayed decisions. Among the functions of the NMRA, the most sacred is to test and verify the quality of drugs. According to the NMRA Act, a laboratory sample test is required, but in more than 90 per cent of cases, the quality of the drug is checked and verified only by file checking. Can the quality of a drug released to the public be maintained by taking a long time just for file checking and adding a huge cost to it?” He alleged that neither of the two officials seemed to have any plan to differ this practice.

The NMRA Chairman and CEO, Drs. Rasitha Wijewantha and Sawin Semage, in a communiqué released on 25 May, refuted allegations levelled against the Authority during the meeting held at the Prime Minister’s Office recently. They observed that the forex crisis was the main reason for the shortage of pharmaceuticals in the country. The dollar shortage is the direct cause for the inability to import raw materials to manufacture drugs locally and to import pharmaceuticals. Also, the inability to access electricity, energy, and transport continually has also dealt a blow to the pharma industry in the country. All these are beyond the control of the NMRA, the duo said. “However, in has done its best within its jurisdiction to stem the present drug crisis in the country.”

Identifying what had been done,
Drs. Wijewantha and Semage said they had set up a separate unit to ensure the quality and efficacy of essential drugs and medical devices the country received as donations, so that it would facilitate their release as soon as possible.

They said another unit had been set up within the NMRA to encourage local pharmaceutical manufacturing, while 150 types of medicinal drugs had been registered within the last two months as projects which required instant approval. The standard of about 20 pharmaceutical manufacturing plants were examined and approved within the last two months. They include four new manufacturing plants, they added.

“One cannot approve pharmaceuticals by their outside appearance, while using a substandard drug could even cause death. Making use of the present situation, the pharmaceutical mafia could import or produce substandard medicinal drugs.”

The NMRA officials condemned the inapt effort made to cripple its regulatory work of even the drugs and surgical equipment the country received as donations in anticipation of future profits. They appealed to the public to act responsibly and understandingly with regard to these absurd allegations being levelled against the Authority.

By Dilanthi Jayamanne