• In conversation with Sri Lanka Chamber of The Pharmaceutical Industry (SLCPI) President Prathaban Mylvaganam

In an insightful interview, Prathaban Mylvaganam, the distinguished President of the Sri Lanka Chamber of The Pharmaceutical Industry (SLCPI) shares his vision for the pharmaceutical sector in Sri Lanka. With a steadfast commitment to patient well-being and accessibility to high-quality medicines, Mylvaganam leads the charge in addressing the challenges faced by the industry and fostering sustainable growth.

From promoting innovation to strengthening international collaborations, he reveals the Chamber's strategic initiatives to propel the pharmaceutical industry into a bright future.

The following are excerpts from the interview: 

Can you provide an overview of the pharmaceutical industry in Sri Lanka, including its current state and major challenges faced by the industry?

The pharmaceutical industry in Sri Lanka can be broadly categorised as importers and local manufacturers. The imports account for around 85% of the total market and the local manufacturers provide about 15% although that segment is fast gaining ground. The total pharmaceutical market is around $ 500 million per annum. We supply essential medicines to both the state and private sector, and we do so while maintaining temperature controls and other conditions as laid down by the manufacturers. Our staff members serve in all parts of the country and their selfless devotion ensured that medicine was the only essential item that was not in short supply during the pandemic years.

The challenges faced by each category are different although there are some challenges common to both importers and manufacturers. These are the rising costs of finished products as well as APIs required for manufacturing that cannot be passed down to the consumer due to price control measures, the lack of a transparent pricing mechanism, the regulatory obstacles at the NMRA, the rising costs of electricity and fuel and the delays in payments by the state sector institutions such as the SPC and the MSD. Added to that is the lack of demand for quality products due to the general economic downturn which makes this a really challenging time for the industry as a whole.

What initiatives or strategies is the SLCPI undertaking to promote the growth and development of the pharmaceutical sector in Sri Lanka?

Sustainable growth can only be achieved by keeping up with the latest developments in the field of medicine. Our aim is not to optimise profits but to ensure that our patients have  access to the best quality medicines at affordable prices by following developing research trends. Our principal companies are in the forefront of research and development as pharmaceuticals are among the most heavily research-based products in the world. By constant exchange of knowledge with our principals, we have always acquired and disseminated such new knowledge to our medical community and through them to the society at large.

We have realised that locally manufacturing at least some of our pharmaceutical needs is of paramount importance in these turbulent times and as such, we have actively fostered the manufacturing segment. Our chamber is working closely with the Sri Lankan pharmaceutical Manufacturers Association in this regard. In fact, most of our member companies have diversified into manufacturing and the line between importers and manufacturers is fading fast. We are looking forward to the day when Sri Lanka can become a net pharmaceutical exporter akin to our giant neighbour, India.

However, there are some highly technical biological products, such as vaccines and anti-cancer products that will always need to be imported. In such cases our chamber works closely with the experts in the relevant fields to find out the products that exactly fit our country's requirements and to source such products at the best possible cost for our patients. We will always consider a healthy population as the best indicator of the development of our industry.

How does the Chamber collaborate with the government and other stakeholders to address issues such as regulatory frameworks, access to healthcare, and affordability of medicines?

The pharmaceutical industry is governed by the National Medicines Regulatory Authority (NMRA) which is in charge of granting and renewing registration to pharmaceutical manufacturing sites as well as the pharmaceutical products. Regulations to govern all aspects of manufacturing, importing, distributing and marketing of pharmaceuticals are laid down and implemented by this authority, making pharmaceuticals, quite rightly, the most regulated products in the country. Even the price of the products is initially decided by the NMRA, and some products are strictly price controlled as well.

It is imperative that the NMRA engages in dialogue with our chamber and all other stakeholders in taking decisions that will have far reaching effects on all our patients. This is especially crucial in arriving at a transparent, equitable and exchange sensitive pricing mechanism for all pharmaceuticals. The chamber is completely engaged in this endeavour with the NMRA and has been in dialogue with all experts in the fields of medicine and economics in order to arrive at a possible solution to this issue.

We are also engaged with other state institutions such as the State Pharmaceutical Corporation (SPC), for arriving at and implementing a bias free tender process and with the Sri Lanka Customs to streamline the importing process so that our patients are assured of a continuous supply of their vital medications.

We strongly feel that only full integration and cooperation between the private and state health sectors will ensure the successful functioning of our industry to the benefit of the patients of our country.

In recent years, there has been a growing emphasis on research and development in the pharmaceutical sector. What is the Chamber doing to foster innovation and encourage local research initiatives?

In the Sri Lankan context, research in pharmaceuticals is still in a very primary state. The only research done in this field hitherto is to carry out the local arm of some multi focal international studies. Even these are few and far between as we lack the ethical framework, the resource personnel, and the finances to carry out large scale research. What we are doing at the current time is to make sure that the country benefits from the new research carried out by our principal companies. For instance, fixed dose combinations are being widely used in other countries as they greatly increase patient compliance by reducing the number of pills that patients have to take. We have been constantly lobbying the NMRA to allow the registration of such products since currently it is not allowing them.

In a recent development, our local manufacturers have been working with the Kotelawala Defense Academy to carry out Bioequivalence studies for their products since they are an NMRA requirement. Although this is still done on a small scale, it is an important first step. It shows that it is important for the state universities to get interested in pharmaceutical research and the chamber and the member companies are always willing to lend our support in such an endeavour.

Sri Lanka is known for its traditional Ayurvedic medicine system. How does the Chamber support the integration of traditional medicine with modern pharmaceutical practices?

Ours is essentially an organisation of companies that import and distribute allopathic medicines. All the doctors that we interact with are also practitioners of allopathic medicines. We have great respect for the indigenous medicines and the practices that have been handed down over generations in our country. It is simply that it is in a different system of practice altogether and as such not in our sphere of activity, as even the government regulator is different from that of our own industry.

That being said, some of our member companies have recently diversified into Ayurvedic medicines in a minor way but even there, such divisions function as separate entities within these companies. It is entirely possible that interaction between these two fields may take place in the future and a more holistic approach to patient care may emerge from that for the benefit of the people.

The COVID-19 pandemic has had a significant impact on healthcare systems worldwide. How has the pharmaceutical industry in Sri Lanka responded to the challenges posed by the pandemic, and what lessons have been learnt?

It must be mentioned that the personnel working in our industry came under the high-risk category during the pandemic due to the nature of their work. They had to interact closely with the healthcare providers and to visit hospitals and clinics regularly in order to perform their duties. This situation was compounded by the travel restrictions, fuel shortages and other logistics problems that cropped up during that time. However, the patients of this country will remember with gratitude that medicines were the only essential commodity that was available freely without any shortage of supply during that time. That is the best illustration of the dedication and the selfless attitude of our staff members during the pandemic. This came at quite a personal cost as a large number of our staff members actually contracted Covid, but thankfully no one succumbed to it.

The industry itself had to adjust to the new shipping regulations, supply difficulties, API shortages and the rise in all costs involved during that time. The post pandemic period brought its own challenges of the rising US Dollar, the economic downturn, difficulties in opening L/Cs nonpayment by state institutions and the general unrest in the country which made our work very complicated. We have adjusted with greatest difficulty by importing limited stocks, managing our stocks carefully and having discussions with our banks to give priority to our shipments. We have also collaborated among ourselves to ensure that although the country may run out of some brands, at least one or two brands of that molecule will be available at all times. The result was that the industry survived and more importantly no patients were deprived of their medicines due to a fault on our side.

In terms of international collaborations and partnerships, what efforts are being made by the Chamber to facilitate trade and cooperation with pharmaceutical industries in other countries?

This is essentially what we do every day. Our partners are the leading manufacturers of pharmaceuticals from around the globe and we sign agreements with them and form long standing partnerships in order to bring down the best pharmaceuticals in the world for our patients. We also engage in constant communication with them in order to keep abreast of the latest developments in the field so that our country can reap the benefit from such developments where necessary.

Additionally, we engage the help of our partners to further the medical knowledge of our doctor fraternity by sending our doctors to medical symposia that are sponsored by our global partners so that the newest medical knowledge that they gain firsthand could be used for the betterment of our patients.

In addition to these, our partners are at the forefront of the two most important facets of the pharmaceutical industry, pharmacovigilance and compliance. Both these aspects are fairly new to Sri Lanka and through our partners we are trying to get the latest insights and guidelines on these two aspects to our local industry in order to bring it in line with the global norms.

What steps are being taken to ensure the quality, safety, and efficacy of pharmaceutical products manufactured or imported into Sri Lanka?

Ensuring quality, safety and efficacy is not something that the pharmaceutical importers and local manufacturers can do on their own. It needs close cooperation and synergy between the state and private sector to achieve this. In essence the NMRA should issue guidelines to importers in order for them to comply with the standards that are specific to our country. It is also the duty of the importers and the local manufacturers to make sure that they adhere to these guidelines scrupulously. Inspection of manufacturing sites, the scrutiny of products before registration, constant monitoring through pharmacovigilance and the strict enforcement of compliance guidelines and ethical marketing practices should, under ideal circumstances, ensure the availability of safe, efficacious, high-quality pharmaceuticals to the population.

The biggest drawback to this ideal situation is the non-availability of a National Drug Quality Assurance Laboratory that is of international standards. Due to this massive deficiency, the NMRA is unable to carry out assays of all products that are submitted for registration and also to carry out random market sampling of products to assure the maintenance of standards. It is imperative that the government finds the funds and the expertise to establish this kind of laboratory so that evaluation of products is not restricted to mere auditing of papers.

Lastly, what are the long-term goals and vision of the Chamber of the Pharmaceutical Industry in Sri Lanka, and how do you plan to achieve them?

As our approach is patient-centric, the goal of the industry is to ensure the accessibility of high-quality pharmaceuticals at affordable cost to our patients. The most important step towards that is to establish a fair, transparent and exchange rate sensitive pricing mechanism for all pharmaceuticals. As mentioned before, this remains the single most important goal of our chamber and its importance can be judged by the fact that we have even sought the mediation of the court of appeal in this instance. We are engaged in active negotiations with the NMRA and the medical fraternity in order to achieve this.

In addition, as mentioned, we are lobbying for an internationally-accredited Quality Assurance Laboratory so that standards can be established with scientific backing through analysis. Also, as a longer-term goal, we are working on bringing the local manufacturers and the importers under one umbrella in order to transition from an import dependent country to a pharmaceutical hub in the region, where our principal companies would consider manufacturing in this country for export markets.

We have also suggested to the Health Ministry to engage our field staff in pharmacovigilance activities so that the state can make use of the countrywide network that we have established to detect and report adverse drug reactions more efficiently and to collaborate with the government to address pressing national issues such as non-communicable diseases (NCDs), dengue, and the misuse of antibiotics.