The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has discussed synergies with the United States Pharmacopoeia (USP) to ensure access to biosimilars particularly in low-and middle-income countries, identify high-risk APIs prone to shortages and global best practices as part of the USP resolutions for 2025-2030.

This discussion happened during the United States Pharmacopoeial (USP) Convention-2025 held recently, which brought together representatives from across the health and science ecosystem to launch the 2025–2030 cycle. During the meeting, USP also announced the newly elected members of its Council of Experts and Board of Trustees for the 2025–2030 cycle, who will play pivotal roles in setting standards and guiding USP's mission.

The meeting included discussions on proposed resolutions aimed at guiding USP's strategic direction over the next five years. Pharmexcil's responded to the USP resolutions for 2025-2030, mentioned below.

The resolutions included expanding access to quality-assured biologic medicines globally. Harmonizing regulations for biologics, especially biosimilars, is crucial to ensuring affordable and equitable access, particularly in low- and middle-income countries. India, as the "Pharmacy of the World," aspires to lead in the biosimilar space with a robust framework and an expanding portfolio of approved biosimilars. Streamlined regulatory processes and global alignment would greatly benefit regional manufacturers by minimizing duplication and speeding up approvals.

As a part of the resolution, USP could view India as a strategic partner in advancing global biosimilar accessibility, leveraging its regulatory expertise and manufacturing capabilities. Pharmexcil also showed willingness to collaborate with USP in identifying market enablers, addressing capacity-building requirements and bridging skill gaps among exporters. Together, Pharmexcil is keen to empower quality advocates like USP to ensure broader access to safe, effective, and affordable biosimilars worldwide.

“Resolution also included enhancing the global pharmaceutical supply chain's resilience. This initiative aligns well with Pharmexcil’s efforts to bolster the pharmaceutical sector. Currently, demand-side data for APIs in regulated and RoW markets is being analyzed. This supports India's aim to strengthen domestic API production while minimizing reliance on neighbouring nations for essential raw materials and KSMs,” a senior official informed.

“USP’s advanced expertise in data analytics and risk-based frameworks can contribute significantly. Pharmexcil has welcomed collaboration with USP in demand forecasting, identifying high-risk API’s prone to shortages and developing strategic plans. Such efforts would not only aid manufacturers but also influence future policy-making and investment strategies. Pharmexcil and its member companies stand to gain immensely from such a partnership,” the official added.

Enhancing regulatory systems worldwide was the final resolution. This is very much relevant as India is undergoing a significant regulatory transformation, including the nationwide rollout of revised Schedule M to improve Good Manufacturing Practices (GMP) compliance across all pharmaceutical manufacturers.

“This resolution offers an excellent opportunity to support these efforts through USP’s global scientific and regulatory strengthening initiatives. USP’s technical expertise, capacity-building tools and tailored dissemination of global best practices can make a substantial impact. Pharmexcil is looking forward to supporting collaborative initiatives that enhance regulatory systems and ensure the sustainability of pharmaceutical quality systems,” according to an official associated with the development.