Pharmaceutical manufacturers Threatens by Regulatory Delays and Missing Industry Ecosystem
Sri Lanka’s pharmaceutical manufacturers believe the country possesses the ingredients to become a regional pharmaceutical exporter but say critical structural weaknesses continue to prevent the industry from reaching international competitiveness.
From lengthy regulatory approvals to the absence of supporting industries, manufacturers argue that several long-standing challenges remain unresolved despite significant progress within the sector itself.
Addressing the Sri Lanka Pharmaceutical Manufacturers’ Association’s 60th Annual General Meeting, newly appointed President Dinesh Athapaththu outlined what industry leaders see as the key barriers limiting future growth.
Among the most pressing concerns is the pace of product registration.
Although the National Medicines Regulatory Authority (NMRA) has reduced processing times over the past two to three years, manufacturers maintain that approvals still take long enough to discourage investment in new products and facilities.
For an industry where innovation and speed are increasingly critical, delays in bringing products to market can have wider economic consequences.
Manufacturers argue that investors are reluctant to commit capital when regulatory timelines remain uncertain.
The industry is now advocating dedicated fast-track approval pathways for medicines manufactured locally, arguing that faster registration would strengthen both domestic production and export readiness.
However, regulation represents only one piece of a much larger puzzle.Industry leaders say Sri Lanka lacks the broader pharmaceutical ecosystem necessary to compete internationally.
Unlike established pharmaceutical manufacturing hubs, Sri Lanka continues to rely heavily on imported packaging materials, specialised laboratory services, bioequivalence testing facilities, and other supporting infrastructure.
This dependence increases production costs while limiting the industry’s ability to scale efficiently.
Manufacturers are proposing public-private partnerships to establish these missing industries locally, believing such investments would strengthen supply chains while creating additional high-skilled employment.
Another challenge lies in innovation.The association argues that local manufacturers can no longer rely solely on producing conventional generic medicines if they hope to compete internationally.
Instead, companies are being encouraged to invest in advanced technologies, specialised pharmaceutical products, and export-oriented manufacturing capable of differentiating Sri Lankan products in global markets.
Human capital also remains central to the industry’s ambitions.Despite producing thousands of science graduates annually, Sri Lanka continues to experience a mismatch between university education and industrial requirements.
Manufacturers are calling for stronger partnerships with universities to develop industry-ready graduates equipped with specialised pharmaceutical manufacturing skills.
Interestingly, the industry rejects the argument that Sri Lanka’s relatively small population limits its pharmaceutical ambitions.
Instead, manufacturers cite countries such as Ireland and Singapore as examples of small economies that have successfully built globally competitive pharmaceutical industries.
They also see India’s pharmaceutical strength not as a threat but as an opportunity to access technology, expertise, and active pharmaceutical ingredients while developing Sri Lanka’s own competitive advantages.
Underlying all these concerns is a common message: pharmaceutical manufacturing requires long-term national planning rather than piecemeal reforms.Industry leaders argue that coordinated action
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