India’s Contract Development and Manufacturing Organisation (CDMO) sector has become a crucial player in the global healthcare landscape. Renowned for leading in generics medicines development and production with US-FDA-approved facilities, India’s pharmaceutical industry aims for substantial growth. In 2020, it reached a market size of US$42 billion, with a target of US$130 billion by 2030. Supplying almost 40% of generic drugs to the US, India boasts 603 US FDA-approved manufacturing sites, the most outside the US.
India’s commitment to quality is evident in addressing 483 observations from the FDA, showcasing continuous improvement. Investments in compliance and quality, including digital systems and automation, enhance efficiency and regulatory compliance.
The Indian government actively supports healthcare, introducing initiatives like the Medical Device Act and mandating quality checks for drug exports. The Promote Research in Pharma (PRIP) scheme fosters innovation and research, supporting the CRO-CDMO sector.
Efforts like the Production Linked Incentive (PLI) Scheme, 100% Foreign Direct Investment, Jan Aushadhi Yojana, and Ayushman Bharat aim to enhance drug production and reduce dependency on imports, promoting self-sufficiency.
Indian CDMOs, like Piramal Pharma, Ajanta Pharma, and Cadila Pharmaceuticals, pass rigorous USFDA inspections, highlighting India’s commitment to global standards. Investments in digital systems and automation further elevate operational speed and rigor.
Despite positive progress, there’s a need for ongoing refinement in regulatory norms to address emerging challenges and advancements, ensuring India’s continued competitiveness in the global pharmaceutical landscape.
