India's Pharmaceutical Manufacturing Advancements

India's pharmaceutical manufacturing sector is closing the quality gap with global peers, often leading in certain areas. The US Food and Drug Administration (FDA) inspection data highlights this trend over the past decade, showcasing improved inspection outcomes for Indian plants compared to global counterparts. This is despite the increased frequency and unpredictability of inspections.

Inspection Outcomes and Industry Response

• Between 2015 and 2025, the share of Official Action Indicated (OAI) outcomes for Indian plants fell from 12% to 8%, while global OAI rates rose from 9% to 13%.
• OAI outcomes indicate serious violations, whereas Voluntary Action Indicated outcomes require corrective steps without enforcement.
• Indian pharma's approach has shifted from episodic compliance to a risk-based, systems-driven quality approach.
• About 80% of OAIs come from smaller firms, indicating larger firms have adhered to global good manufacturing practices (GMP) standards.

Regulatory Focus and Technological Integration

• Inspections now focus on contamination risks, cleaning validation, and infrastructure integrity.
• Automation in quality control and documentation is scrutinized for GMP understanding by outsourced providers.
• The industry is developing a talent-, trust-, and technology-led ecosystem, with training programs and AI integration.
• AI is used for quality monitoring and maintenance, but final decisions rest with human oversight.

Global Context and Supply Chain Challenges

• India plays a significant role in global affordability, supplying generics that constitute 90% of US volumes but only 13% of value, saving the US $200 billion annually.
• Supply-chain resilience is challenged by reliance on China for certain APIs and low-cost machinery.
• India exports more APIs than it imports, with slow import growth following production-linked incentives.
• Domestic machinery capability is supported as a diversification strategy, despite cheaper Chinese alternatives.

Export Ambitions and Quality Credibility

• India supplies medicines to over 200 countries, with ambitions to scale exports from $30 billion to $80 billion.
• Regulatory alignment and engagement with local regulators are crucial for expanding exports, especially in Africa and Latin America.
• Quality credibility is key for attracting global clinical trials and contract manufacturing work.