The Association of Medical Specialists (AMS) has written to Prime Minister Ranil Wickremesingh, expressing its grave concern over recent media reports of intended ‘administrative restructuring’ of the National Medicines Regulatory Authority (NMRA) for ‘establishing a system to import medicine, bypassing the NMRA’. These attempts are being pushed by unscrupulous elements with vested interests trying to blame the NMRA for the shortage of drugs in the country, the AMS has said in its letter signed by Dr LakKumar Fernando President-AMS, and Dr R Gnanasekeram General Secretary-AMS

The AMS has pointed out that NMRA was established through an Act of Parliament (NMRA Act No 5 of

2015) in 2015 to provide regulatory oversight for medicinal products. It was established as an apex body independent of the Department of Health with the sole objective of improving availability of quality assured medicines and medical devices to our people. By engaging in such NMRA ensures professionalism and transparency in the regulatory process. This is in line with global good regulatory practices and good governance, strongly encouraged, endorsed and supported by the World Health Organization.

The AMS letter to the PM further says: “It should be noted that the NMRA as a regulatory body have absolutely no role to play in the procurement of medicines to state or other agencies. As all of us are very well aware, the present drug shortage in the country is due to lack of foreign currency where main purchasing arm (SPC together with MSD) could not place necessary orders on time and NMRA has no responsibility in this matter.

“Therefore, we feel that these allegations are baseless and unfounded. Such allegations are fabricated intentionally to destabilize the well-established regulatory system of medicines in our country. In our opinion, blaming the medicines regulator on the current shortage of certain medicines and medical devices is baseless, irrational and totally unacceptable.

“Further, we are aware that the NMRA acted promptly and proactively in establishing a mechanism to accept donations of medicines in the present crisis. Unfortunately, the support received from some of the directorates of the ministry of health in this endeavor was not encouraging.

“It is very important to note that interfering with the independence of the National medicines regulator is a retrogressive step, which will only pave the way to undesirables to profiteer at the expense of general public who have already been hit hard by the spiraling economic downturn. Many attempts have been made to meddle with the independence of the NMRA in the recent past at the behest of politicians and businesses with vested interests. Continuing to do so will ultimately destroy the NMRA, compromising the safety and efficacy of medicines available to the public.

“Therefore, we urge the Hon. Prime Minister and the Hon. Minister of Health not to be misled by poor advice of various elements with vested interest. Instead, we urge you to take meaningful steps to solve the issue of dearth of medicines whilst strengthening the independence of the NMRA. At the same time, the Association of Medical specialists will not hesitate to take appropriate action if the independence and the autonomy of the NMRA is interfered with.”