Historically known for their strength in generic drug manufacturing, today, Indian pharma firms are increasing their in-licensing transactions with international drug innovators. Big Indian pharma firms such as Cipla, Sun Pharma, and Dr. Reddy’s are acquiring rights to new patented products in the oncology, diabetes, central nervous system, and cardiovascular segments to drive their portfolio growth, reduce geopolitical risk, and enhance market reach. Cipla, for example, has expanded its in-licensed portfolio by 40% over the last five years. The model is considered to be of mutual benefit, giving Indian drug companies access to innovative drug products and global players with a fast entry point into emerging markets. In spite of pricing pressure and regulatory issues, the success of Takeda’s acid blocker drug vonoprazan in India recently shows the model is gaining pace. Industry experts predict that this phenomenon will continue to gain traction in India’s pharma sector in the coming decade.
On July 3, 2025, the city of Beijing issued a three-year (2025–2027) action plan for the application of artificial intelligence (AI) in the pharma and healthcare industry, including drug regulation, across the nation. The plan includes 15 essential tasks, including AI-based data extraction, regulatory review, and real-world data analysis, to make the decision-making process in drug oversight more efficient. The move comes ahead of an upcoming national-level AI action plan, which should soon be announced by the China NMPA. The early adoption of AI is likely to be used in automating repetitive regulatory work, including completeness checks for submissions and review of generic drug submissions. However, it may take a while before AI can be used in clinical development due to regulatory hurdles and AI’s limited causal reasoning capabilities.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.