India’s New Data Protection Standards and Its Impact on Pharma Industry

Recently, India has come up with the Digital Personal Data Protection (DPDP) Act, which will ensure strict data privacy rules and affect clinical trials and global capability centers (GCCs) of multinational pharmaceutical companies in the country. This law creates its standards of compliance with how to handle sensitive personal health data – a critical aspect in clinical research and pharma operations — by matching the existing global standards like the EU’s GDPR. While the changes bring more transparency and strengthen patient privacy, they also mean operational challenges for companies conducting trials and managing global data from India.

The DPDP Act specifically requires informed consent for data collection and cross-border data transfers in clinical trials, which could further complicate multinational studies. A more stringent regulatory framework may translate into heavier administrative burdens on companies to ensure that they are in compliance with new data localization rules and have robust mechanisms for data governance. While the changes seek to protect participant rights, they may also impact India’s attractiveness as a clinical trial hub because sponsors might reconsider trial locations.

Challenges in compliance will also be faced by the GCCs of international drug companies, which have evolved from back-office operations to innovation and R&D hubs. These centers, storing huge volumes of patient data and research insights, need to strengthen cybersecurity measures while ensuring smooth data flow to keep up with the new requirements.

Regulatory clarity in India, despite its challenges, should bring greater global confidence to the country’s digital health ecosystem. Companies that can proactively adapt with strong compliance frameworks to these new standards will get a competitive edge.


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.