Navigating Data Protection Compliance in Pharma and Life Sciences Under India’s DPDP Regime: Clinical Trial Data, Research Exemptions and Patient Privacy

Posted On - 10 February, 2026 • By - Aniket Ghosh

Introduction: When Medical Innovation Meets Data Protection Law

India has emerged as a global hub for pharmaceutical manufacturing, clinical trials, contract research, bioequivalence studies and life sciences innovation. Multinational pharmaceutical companies, Indian drug manufacturers, contract research organisations (CROs), biotech startups and academic institutions increasingly rely on large-scale processing of human data to accelerate drug development, reduce costs and improve outcomes.

Clinical trials, observational studies, real-world evidence generation, pharmacovigilance and post-marketing surveillance are all fundamentally data-driven activities. They involve the collection and processing of deeply sensitive personal information including medical histories, genetic data, diagnostic results, adverse event reports, behavioural data and long-term health outcomes meaning they need to deal with India’s data protection compliances.

With the enactment of the Digital Personal Data Protection Act, 2023 (“DPDP Act”) and the notification of the Digital Personal Data Protection Rules, 2025 (“DPDP Rules”), India has fundamentally altered the legal landscape governing how such data may be collected, used, shared and retained.

For the pharmaceutical and life sciences sector, the DPDP framework presents a dual challenge:

  1. Ensuring compliance with a strict, consent-centric data protection regime; and
  2. Preserving the feasibility of scientific research, innovation and global clinical collaboration.

This article examines how India’s data protection law applies to pharma companies, CROs, biotech firms and research institutions, focusing on:

  • Clinical trial and research data processing
  • Consent, anonymisation and research exemptions
  • Cross-border data transfers in global trials
  • Liability allocation across sponsors, CROs and investigators
  • Penalties, enforcement exposure and reputational risk
  • Practical compliance and mitigation strategies

Applicability of the DPDP Act to Pharma and Life Sciences

A. Who Is Covered?

The DPDP Act applies to any entity processing digital personal data, including:

  • Pharmaceutical manufacturers
  • Biotech and genomics companies
  • Contract Research Organisations (CROs)
  • Clinical trial sponsors and investigators
  • Hospitals and trial sites
  • Academic and institutional research bodies
  • Pharmacovigilance service providers
  • Health data analytics and AI-based research platforms

Both Indian and foreign sponsors conducting trials or research involving Indian participants fall within scope, including offshore processing of Indian clinical data.

B. Data Fiduciaries and Data Processors in Clinical Research

In the clinical research ecosystem, multiple actors may qualify as data fiduciaries, including:

  • Trial sponsors (who design and control studies)
  • Research institutions (in certain investigator-initiated trials)

CROs, labs, data management vendors, cloud providers and analytics firms typically act as data processors, processing personal data on the sponsor’s instructions.

Crucially, under the DPDP Act, primary compliance responsibility rests with the data fiduciary, even where processing is outsourced. Contractual delegation does not absolve sponsors of liability. Large pharma companies and CROs processing sensitive health data at scale may be notified as Significant Data Fiduciaries (SDFs), triggering enhanced governance obligations.

Nature of Data Processed in Pharma and Life Sciences

A. Clinical Trial and Research Data

Clinical research involves processing of:

  • Medical histories and diagnoses
  • Laboratory results and imaging data
  • Adverse event and safety data
  • Genetic and genomic information
  • Demographic and lifestyle data
  • Longitudinal follow-up data

Even where identifiers are replaced with codes, such data may still constitute personal data if re-identification is reasonably possible.

B. Genetic and Genomic Data: Irreversible Risk

Genetic data is particularly sensitive because:

  • It is immutable
  • It reveals information about family members
  • It carries long-term discrimination risk

While the DPDP Act does not create a separate “sensitive data” category, regulators are likely to treat genetic data as high-risk personal data, warranting stricter scrutiny.

Clinical trials in India already require informed consent under:

  • Drugs and Cosmetics Act
  • ICMR ethical guidelines
  • Good Clinical Practice (GCP) standards

However, ethical consent is not automatically equivalent to DPDP-compliant consent.

Under the DPDP Act, consent must be free, informed, specific, unambiguous and capable of being withdrawn. This raises difficult questions in clinical research:

  • Can consent be “free” where participation is linked to access to treatment?
  • How is withdrawal handled once data has been analysed or shared globally?
  • Can consent for future research be truly “specific”?

Legacy consent forms often fail to meet DPDP standards due to:

  • Broad future-use clauses
  • Ambiguous data sharing disclosures
  • Lack of clear withdrawal mechanisms

Research Exemptions and Anonymisation: The Most Misunderstood Area

The DPDP Act permits certain exemptions for processing personal data for research purposes, subject to conditions. However, exemptions are not blanket carve-outs. They depend heavily on effective anonymisation. Entities relying on assumed research exemptions without robust safeguards face significant risk.

B. The Anonymisation Fallacy

Many pharma and research entities assume that “Coded” data = anonymised data.  “Pseudonymised” data = outside the DPDP Act. This assumption is legally unsafe. Data is anonymised only if re-identification is reasonably impossible, considering available technology and data sets. In many clinical trials:

  • Sponsors retain re-identification keys
  • Data is linkable across datasets
  • Longitudinal tracking is essential

Such data is likely to remain personal data, subject to full DPDP obligations.

Purpose Limitation and Secondary Use of Research Data

A. Primary vs Secondary Research Use

Clinical data collected for a specific trial is often later used for:

  • Secondary analysis
  • AI model training
  • Drug discovery pipelines
  • Comparative effectiveness studies

Under the DPDP Act, secondary use requires fresh legal justification, often fresh consent.

B. AI and Machine Learning in Life Sciences

Use of historical clinical datasets to train AI models presents unique risks:

  • Legacy consents may not cover AI use
  • Data may be repurposed far beyond original intent
  • Cross-border model training complicates compliance

Assumptions that AI training qualifies as “research” are increasingly vulnerable.

Cross-Border Data Transfers in Global Clinical Trials

A. Structural Dependence on Cross-Border Transfers

Global trials routinely involve transfer of Indian participant data to:

  • Global sponsors
  • Central labs
  • Data safety monitoring boards
  • Regulatory authorities

Under the DPDP Act, cross-border transfers are permitted only to government-notified jurisdictions.

B. Compliance Challenges

Pharma companies must now:

  • Map global data flows
  • Monitor Indian government notifications
  • Reassess global trial architectures
  • Consider localisation or segmented storage

Failure to anticipate restrictions could disrupt ongoing trials.

Pharmacovigilance and Mandatory Reporting

A. Adverse Event Reporting

Pharmacovigilance requires long-term retention of patient data, disclosure to regulators, and continuous monitoring. While such processing may be legally required, entities must still limit use to necessity, secure data appropriately and maintain audit trails. Regulatory obligations do not eliminate DPDP compliance duties.

Data Breaches: Regulatory and Ethical Fallout

A. Mandatory Breach Notification

Under the DPDP Act and Rules, breaches involving clinical data must be reported to the Data Protection Board of India and affected data principals.  This applies even where no immediate financial harm occurs and also where data is research-related.

B. Impact on Trials and Trust

Clinical data breaches can:

  • Invalidate trials
  • Trigger regulatory suspensions
  • Lead to participant withdrawal
  • Cause irreversible reputational damage

In life sciences, trust is integral to participation and legitimacy.

Penalties and Enforcement Exposure

A. Monetary Penalties

The DPDP Act authorises penalties up to INR 250 crore per contravention, assessed based on:

  • Sensitivity of data
  • Scale of processing
  • Duration and recurrence
  • Mitigation measures

Health and genetic data violations are likely to attract stringent enforcement.

B. Collateral Consequences

Beyond penalties, non-compliance may result in:

  • Regulatory action by drug authorities
  • Loss of global sponsor confidence
  • Trial delays or cancellations
  • Litigation and class-action risk

Compliance Roadmap for Pharma and Life Sciences Companies

1. Data Mapping and Classification: Identify all categories of clinical, genetic and research data.

3. Anonymisation and Research Governance: Implement robust, defensible anonymisation frameworks.

4. Cross-Border Transfer Strategy: Plan jurisdiction-aware data storage and access models.

5. Vendor and CRO Contracts: Update agreements to allocate DPDP obligations and breach liability.

Conclusion: Enabling Innovation Without Sacrificing Privacy

The DPDP Act and Rules do not seek to stifle medical research or pharmaceutical innovation. Instead, they demand a recalibration of how human data is treated from a freely exploitable research input to a legally protected extension of individual dignity.

Pharma and life sciences organisations that proactively embed privacy-by-design, strengthen consent governance and rethink legacy assumptions about anonymisation will be best positioned to:

  • Sustain global research collaborations
  • Maintain regulatory trust
  • Protect participant rights
  • Future-proof innovation in India