• Plans to expand local quality control testing laboratory capacity expeditiously
• Has cleared importer registration and domestic manufacture approval backlogs
• Is in urgent need to fill gaps in staff requirements, plans to amend legislation

Following multiple controversies over pharmaceutical imports, import delays, and quality of pharmaceuticals in the Sri Lankan market, the national regulator; National Medicine Regulatory Authority (NMRA) has moved to streamline registration, import approval and quality compliance control mechanism. 

The NMRA plays a leading role in protecting and improving public health by ensuring medicinal products available in the country meet applicable standards of safety, quality, and efficacy.

The regulator remains handicapped by staff shortages and infrastructure and is planning to update relevant legislation to keep up with best practices, while trying to improve quality control and testing regime which is in need of capacity building. The regulator has also moved to clear backlogs, enabling the increase of domestic pharmaceutical industry, which had been identified as a priority during the foreign exchange crisis and disruptions to global supply chains.

In an exclusive interview with The Daily Morning this week, NMRA Chief Executive Officer (CEO) Dr. Saveen Semage discussed the challenges faced by the regulator and the current status quo.

Following are excerpts from the interview:

Over the last few years, there has been much concern and controversy over medicine imports, their regulation, and quality control. The NMRA has been criticised for delays and failures in quality control. What is your response to such allegations?

Yes, there was sought of a bad patch during 2022 and 2023 with regards to the working of the NMRA, and the entire procurement and supply chain of medicines. However, in January 2024 a change in management took place. The new Chairperson Dr. Ananda and I joined the management.

When we took over, the NMRA was a mess, there were massive backlogs of unprocessed applications, our laboratories were not up to mark to ensure our mandate which is to ensure the quality, safety and efficacy of the healthcare products used in Sri Lanka.  It was observed that there had been many procedural changes which had been made, and this posed a significant challenge for us to streamline and get the procedure in order. We had to clear the backlog in registration of existing products which are in use in Sri Lanka, they numbered about 1500 products. 

It had not been attended to since 2019. The products we learnt had been allowed into the country on shipment clearance basis, and without any evaluation of quality. We realised that this practice had led to an uptick in fake shipment clearance documentation. So, many shipments had been cleared with fake documents. 

Also, on top of fake documents, there was also no price control. So, the new administration halted the practice, and we have not issued any shipment clearance certificates in 2024 and we cleared the backlog. The WRA issue was done without due process, this is now being dealt with before the Court.

We have introduced a secure – a new import approval certificate. I don’t want to go into details about its many safety features, which ensures authentic documents. We have also moved online the clearing system of the Customs department, which makes it more streamlined and secure. So, this reduced malpractice.  By now, we have included air cargo clearance to our system as well. So, this has essentially reduced the inflow of unregistered pharmaceuticals due to this new process, we see this as a milestone in our regulatory capacity. We have also established a new market control division which looks into the domestic market and carries out surveillance to detect fake products and unlicensed products in the market.

Sri Lanka has a growing domestic pharmaceutical industry, there have been concerns about its regulation. Can you explain what measures have been taken to improve regulations and compliance?

Yes, we give high priority to improving regulations of local manufacturing. The state policy is to improve and encourage local manufacturing. We have introduced a strict quality control programme for local industry. We also found a large backlog of pending registrations for local manufacturing which needed approval, we have cleared the backlog and for 2024 – we have approved nearly 200 licences for local manufacturing. This has also improved the Government’s local supply portfolio by nearly one third. We started with 256 by the end of 2023 (which has been the buildup over the last 15 years). By the end of 2024, 306 medicines in the government supply were being supplied by local manufacturers. There are several new manufacturing sites which will come up by the end of 2026, and it will likely contribute to more capacity from local industry. We conduct good manufacturing practices GMP audits to ensure compliance. We have a mandatory system to inspect their manufacturing facilities every two years. Of course, we do random and as required GMP audits of them as well. We have also adopted a policy to give local manufacturers a higher profit markup than importers.

Is the legal framework of the NMARA adequate?

The NMRA act as an independent regulator was established in 2015. So, now after a few years, we see some legislative gaps we need to address. We have identified that we need to amend the Act, and we are now working on doing so. A committee has been formed for the task, and we are compiling a draft. One important area which the current Act doesn’t cover is cosmetics. This has been felt as a need for the last nine years. Also, we also need to create an appeals committee. So, we are planning to appoint a national advisory committee and an appeals committee for that task. The new minister has been helpful in the endeavor.  

We also need to address the price control issue. We have been having consultations with relevant parties, and soon we should be able to issue the relevant gazette which will help reduce the prices of some medicines in the markets. We will publish the mechanism soon. This is an important part of our mandate; it is after nine years that we are doing so. It has been a lengthy process.

In terms of being well resourced, how do you view where NMRA stands today?

We are self-funded. We have a human resource issue. We are having an ongoing conversation with the Finance Ministry’s Management Services Department. It has been tough to get approval for the carder recruitment. But I feel confident we can commence recruitment soon. The ministry has indicated that we will get the essential staff that we need. We were running at 25% of the staff we needed, so you can appreciate the difficulties in getting things done. All our achievements have been made over the last two years, we have done so with 25% of the staff we need. We have proposed a carder revision, we may need to double the level of our current numbers to provide the services we need to provide.

We also have a space issue. We are in a place temporarily, we need to find a bigger location for a permanent place. Those are the constraints we have. If we had both the staff and the infrastructure we could have done more.

There were concerns about inadequate testing facilities (laboratories) for the NMRA to carry out their quality control checks effectively. Is this issue being addressed effectively?

Yes, we are working on this critical issue. We have two goals. On the regulatory part, there is a benchmarking system by the World Health Organisation (WHO), called maturity levels. At present, we are at maturity level one, which is the lowest level. When compared to other health sector levels in Sri Lanka, the regulatory system is at a low level. So, the legislative changes we have planned for us will help to elevate to level three. Our aim is to reach level three by 2026. We have a road map for it and are in consultation with WHO on getting there. So, we are developing new SOPs, and mechanisms to meet those standards.

The maturity level three is considered a stringent authority, like Malaysia. We need to reach that level, which is our broader goal.

In relation to the laboratory capacity building, we will use the Noris canal premises for the quality control laboratory. The renovations have begun. We have also recruited 15 analysts. We want to hire another 25 within the next few months. We recruit some of the best qualified people available in Sri Lanka, all of them are B.Com graduates. There is a lot of interest in joining the NMRA. When we advertised, we received over 1000 applications. There has been interest shown from the private sector and even some residing overseas. So, we plan to increase our capacity and capabilities. We are planning to build a well-equipped, modern laboratory. It will be a complete overhaul of the system. Our plan is to finish the renovation and equip the lab by one year. However, that will be a laboratory of the basic standards. We are keen and so is the Ministry of Health on developing a state-of-the-art laboratory later on, perhaps at a separate venue, which will likely include the biological testing. However, that will take some time. 

NMRA CEO Dr. Saveen Semage 

PHOTO Krishan Kariyawasam