|
Experts discussed solutions in enhancing API manufacturing quality at the recently concluded 5th South Asia Regional Chapter Meeting as part of the USP Convention 2025.
The 5th South Asia Regional Chapter Meeting as part of the US Pharmacopoeia (USP) USP Convention 2025, opened by Dr. Suresh Bhojraj, USP South Asia Regional Chapter Chair, reaffirmed the importance of collaborative stakeholder engagement in enhancing API manufacturing quality and achieving regional pharmaceutical self-reliance. Dr. Bhojraj emphasized the need for the chapter to evolve into a more dynamic, outcome-oriented platform, while Dr. Girish Kapur, senior vice president (VP), and USP India Site Head, showcased USP Hyderabad’s advanced capabilities and global integration.
Chandrasekhar Ranga, deputy drugs controller (DDC) at the Central Drugs Standard Control Organization (CDSCO) emphasized the need for better industry-regulatory dialogue to address outdated monographs and evolving manufacturing practices.
Raja Bhanu, director general, Pharmaceuticals Export Promotion Council of India (Pharmexcil) suggested USP to establish a feedback platform for industry-reported issues, modelled on their export-linked issue tracker. The Indian Drug Manufacturers Association (IDMA), represented by Dara Patel, secretary general highlighted environmental compliance as a key challenge in API manufacturing, citing inadequate pollution control infrastructure. He urged USP’s support for best practices in effluent treatment and policy advocacy for green chemistry and sustainability.
Other important key quality issues highlighted included pharmaceutical water quality, cross-contamination, nitrosamine impurities and cleaning validation setting the stage for solution-driven discussions.
Dr. Rajiv Desai, senior technical advisor, Indian Pharmaceutical Alliance provided valuable insights on Indian Pharmaceutical Industry. The Directorate General of Drug Administration (DGDA), Bangladesh, highlighted the country's dependence on imported APIs and requested technical assistance and regional collaboration to build domestic capabilities.
Dr Nitish Sharma, assistant professor from National Institute of Pharmaceutical Education and Research (NIPER) Ahmedabad underscored the need for early-stage risk assessments for nitrosamines and leachables
Dr. Chaitanya Koduri, director of International Government and Regulatory Engagement (IGRA) at the USP reflected on the journey since the chapter’s inception in 2020 and acknowledged the regional platform’s unique ability to tailor global quality standards to local needs. He appreciated the leadership of Dr. Bhojraj and contributions from all stakeholders, reaffirming USP’s commitment to strengthening South Asia’s API manufacturing ecosystem. Key next steps include development of a practical SME toolkit, expanded training programs, continuation of regional roundtables and policy-level coordination to guide the 2025- 2030 strategic roadmap for API self-reliance.
|