The Ministry of Electronics and Information Technology (MeitY) has released the draft Digital Personal Data Protection Rules 2025 (DPDP Rules) for public consultation, aiming to facilitate the implementation of the Digital Personal Data Protection Act 2023 (DPDPA). These rules are expected to reshape data governance across industries, particularly the biopharma, life sciences, and healthcare sectors. Stakeholders have until February 18, 2025, to provide feedback on the draft.
Impact on Biopharma and Healthcare
Commenting on the implications of the DPDP Act, Tisha Bhambry, Director Analyst at Gartner, highlighted the transformative potential and challenges posed by the legislation. These sectors, heavily reliant on data for clinical trials, drug discovery, genetic research, and patient care, face stringent requirements for data protection and consent management.
“The Act mandates that personal data be used strictly for the purposes for which it was collected unless explicit consent is obtained for additional uses,” said Bhambry. This makes clear communication with data principals about data usage and consent processes critical. Handling data related to children and minors will also require verifiable guardian consent and robust documentation, ensuring compliance with the law.
While the Act provides certain exemptions for research activities, these exemptions come with the responsibility to adhere to specific standards. Organizations must ensure secure and lawful data processing while maintaining purpose limitations. Bhambry emphasized, “This exemption facilitates research while maintaining essential data protection principles.”
Cross-Border Data Transfer Challenges
One of the more complex aspects of the DPDP Act pertains to cross-border data transfers. Bhambry noted that restrictions on data transfers to certain countries could impact international collaborations in biopharma and healthcare. Organizations will need to adapt their data management strategies to ensure compliance with both domestic and international regulations, maintaining smooth data flows for global operations.
Opportunities Amid Challenges
Despite the challenges, Bhambry identified opportunities for innovation in data management. The DPDP Act’s emphasis on privacy and security could foster trust among stakeholders, including patients, research participants, and healthcare providers. This trust is particularly critical as the healthcare and biopharma industries increasingly adopt AI and cloud-based platforms.
“Aligning data practices with the Act’s requirements will be crucial for leveraging these technologies effectively and maintaining compliance with evolving regulatory standards,” Bhambry said. She also stressed the importance of establishing a comprehensive privacy program that integrates governance, risk management, and compliance across all data processing activities. Such initiatives, she added, not only ensure regulatory compliance but also position organizations as leaders in data protection and privacy.
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A Path Toward Trust and Innovation
By prioritizing privacy, security, and transparent data usage, the DPDP Act presents an opportunity for healthcare and biopharma organizations to redefine their data management frameworks. As Bhambry concluded, “This approach will ultimately foster greater trust and engagement with patients, research participants, and other stakeholders, ensuring that innovation in healthcare and biopharma aligns with ethical and regulatory standards.”
The DPDP Rules represent a significant step toward modernizing India’s data governance framework, with the potential to balance innovation, compliance, and trust across key sectors.
