India Ratings and Research (Ind-Ra) in its latest report has said that the US-focused domestic pharmaceutical companies need to step up their regulatory compliance to secure impeccable status as dependable suppliers and provide the targeted return on the ongoing and planned research and development (R&D) and capital investments over the next decade. It noted that as operating environment within the US has undergone a shift following growing competition and increasing buying power of customers, product quality and uninterrupted supply have become focus points for commercial success. It added that this translates to a robust approach to regulatory compliance for manufacturing facilities.
According to the report, from the second half of 2017, the industry has been seeing resolution of key manufacturing facilities of large manufacturers under warning letters and import alerts with an average period of 24 to 36 months after regulatory restriction. It warned that while this is encouraging, a reduction in resolution times and limited repeat observations would indicate regulatory discipline retuning to the industry.
Ind-Ra further stated that input quality risks stemming from high dependence on Chinese players has been an emerging concern in FY19, leading to product recalls initiated by major players. Therefore, it said securing supply chain is likely to emerge as top priority as several complex generics and innovative pipelines will hit the markets in the next decade. It pointed out that the credit profile and return ratios of companies with regulatory deviations have been adversely impacted attributed to remediation cost and restricted market presence.
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