Experts Address API Manufacturing Quality at USP Convention 2025

The 5th South Asia Regional Chapter Meeting during the USP Convention 2025 featured industry professionals and stakeholders gathering around key issues of improving the quality of Active Pharmaceutical Ingredient (API) production. The conference was addressed by Dr. Suresh Bhojraj, Chair, USP South Asia Regional Chapter, who spoke on the need for the convergence of stakeholder action towards regional pharmaceutical self-reliance. Dr. Bhojraj also challenged the chapter to become a more active, outcome-oriented platform for sustainable influence.

Dr. Girish Kapur, Senior Vice President and USP India Site Head, spoke about the cutting-edge capabilities of USP Hyderabad and its position on the international map in the pharma segment. Chandrasekhar Ranga, Deputy Drugs Controller, CDSCO, emphasized the necessity to intensify industry-regulatory interaction, especially addressing older monographs and altered manufacturing practices.

Raja Bhanu, Director General Pharmexcil, suggested that USP create an industry-reported issue feedback system like the export-linked issue tracker. Dara Patel, Secretary General IDMA, highlighted environmental compliance as a critical aspect of concern and asked USP to nurture best practices in effluent treatment and green chemistry efforts.

Also Read: The Future of Green Chemistry in API Production

A few of the key topics under discussion were pharmaceutical water quality, cross-contamination, nitrosamine impurities, and cleaning validation. Dr. Rajiv Desai, Senior Technical Advisor, Indian Pharmaceutical Alliance, presented valuable insights about India's pharma landscape, while Bangladesh's DGDA appealed for technical assistance for API self-sufficiency.

USP's Dr. Chaitanya Koduri looked back at the chapter's journey since 2020, applauding Dr. Bhojraj's vision and setting down the agenda for the future, SME tool kit creation, long-term training programs, and ongoing policy synchronization to create the 2025-2030 API self-reliance strategy.