PHARMACEUTICAL SECTOR
SHORT TAKES
Compiled by Savithri Rodrigo
Kasturi Chellaraja Wilson
Shyam Sathasivam
Q: What’s your take of the regulatory environment surrounding pharmaceuticals?
Kasturi Chellaraja Wilson (KCW): Multiple changes including price controls on essential drugs have made quality medicines more affordable. However, the lack of a mechanism to regulate pharmaceutical prices results in uncertainty for the sector in the context of ensuring a sustainable supply of drugs and amid external pressures such as a depreciating rupee.
Shyam Sathasivam (SS): Product registrations were delayed in the transition from the Cosmetics, Devices and Drugs Act to the National Medicines Regulatory Authority (NMRA) due to red tape, backlogs, understaffing and internal politics. Four years on, there’s more streamlining and efficiency with NMRA announcing that it is on the cusp of full automation.
Q: Is the sector taking adequate measures to ensure product quality?
KCW This requires focus and improvement. It’s essential for all medicines – locally manufactured and imported – to be subject to rigorous quality testing; not only at the point of registration but also in the market. The government intends to establish a robust quality testing laboratory, which must become a reality to ensure the quality of medicine.
SS Shortcomings in regulation, and the execution of pre and post-market surveillance, have led to poor quality products. Post-market surveillance is more compliance based rather than proactive. While the NMRA Act led to ‘pharmacovigilance’ as well as ‘inspectorate and enforcement’ divisions, it does not provide speci-fic guidance on implementation.
Q: What are your views on local production compared to imports?
KCW They are complementary in nature. Imports provide access to vital and innovative molecules including new age diabetic treatments, and oncology and combination drugs, ensuring a better quality of life. Also, they support patient safety and adherence. Building local manufacturing capacity will improve the availability of and access to essential medicines provided that adequate control systems are in place.
SS It’s encouraging that the ministry’s agenda is to boost local production to increase national health security and self-sufficiency in terms of 250 essential medicines. Importers can play a greater role by providing revolutionary therapy in oncology, new generation medications, branded medicines and devices, nutraceuticals and over-the-counter supplements, to engender an open market and assist when there are drug shortages locally.
Q: Could you pinpoint the major trends or innovations in pharmaceuticals?
KCW Noncommunicable diseases (NCDs) are the leading cause of death and disability, so there is a higher demand for cardiovascular, Type 2 diabetes and hypertension medicines. Biologics have revolutionised cancer treatment, delayed or reversed the course of immune conditions and changed the lives of people with rare diseases. AI as well as machine and deep learning will continue to witness major investment.
SS Traditional retail supply chains have been disrupted by the likes of Amazon. In Sri Lanka too there’s been innovation with virtual consultations, delivery of medicines with only photographs of prescriptions and the introduction of outlet-wise indices that indicate the availability of drugs through messaging platforms. This has broadened the availability of and access to medications.
Q: As for sector R&D, where does the Sri Lankan market stand?
KCW It remains in a nascent stage where pharmaceutical R&D is concerned. Against this backdrop, R&D will require substantial investment and technical know-how.
SS The establishment of a state biotechnology institute is vital. While the Industrial Technology Institute and Medical Research Institute have R&D capabilities, they focus on quality assurance.
Q: What are the key challenges facing the sector at present?
KCW A lack of policy transparency and consistency has hindered sector operations. To move forward, we must fast track the establishment of a pricing mechanism; invest in reducing the regulatory backlog, obscurity in approvals and decision making; and increase the regulator’s capacity to monitor the quality of pharmaceutical products.
SS Apart from insufficient funding, growing NCDs, an ageing population and pharmaceutical shortages in the state sector, the key challenges are low confidence in the quality of generics, ad hoc imposition of price controls, the rupee’s depreciation against the dollar and introductory pricing refinements to avoid molecules being priced below cost.
Q: Which countries have potential for collaboration and investment in pharmaceuticals?
KCW This includes nations such as India whose capacity is under threat with markets such as the US opening up.
SS Southeast Asia is a hub for pharma innovations with China leading in active pharmaceutical ingredients (APIs), and India, Pakistan and Bangladesh in finished formulations.
Q: How do you view the procurement process vis-à-vis essential medicines?
KCW Weaknesses in government procurement result in a huge cost to the country and its citizens. Guidelines must be strongly enforced to make sure that procurement considers both the technical aspects (i.e. quality) and price of products. Transparency in the procurement process is critical to ensure increased accountability.
SS Our tender system, which is better than that of regional countries, requires improvement – particularly in bureaucracy, transparency and nepotism. The lowest cost being the only criteria results in inefficiencies, low quality products, avoidable hospitalisation and higher drug bills. A better quality assurance mechanism must be enacted.
Q: Do you believe that price revisions for these products are justified?
KCW Accessibility is key so price revisions are justifiable. However, there have been instances where the enforced pricing was unsustainable, resulting in drugs being withdrawn from the market. Shortages can impede accessibility and thereby consumer health. The viability of the Sri Lankan market for multinationals enables it to receive innovative technology that can’t be supplied locally.
SS It is a positive step that’s welcomed by consumers. However, due to a lack of transparency in the pricing formula and with the rupee’s depreciation, there are instances when the cost of production or importation was greater than the maximum retail price. If this threat continues, Sri Lanka will no longer be viewed as an attractive market by international manufacturers and consumers could be affected.
Q: Would a ‘pharmacare plan’ as mooted by some nations make sense for Sri Lanka?
KCW Sri Lanka’s public health system is excellent but state sector resource utilisation and capacity constraints can be better managed through public-private partnerships using excess capacity in the private sector.
SS A ‘pharmacare plan’ could be a way to introduce greater efficiencies through subsidised private sector participation. Nevertheless, we have to address the underlying issues permeating the healthcare sector.
