Pharma
DPDP Compliance for Pharma Companies
Pharmaceutical companies process personal data across clinical trials, pharmacovigilance programs, patient support programs, prescription data analytics, and healthcare provider interactions. This data is not just personal much of it is Special Personal Data under DPDP. Compliance requires purpose-specific consent, governed cross-border data flows, and data subject rights management across complex, multi-stakeholder ecosystems.
The Reality
Pharma data governance is compliance-heavy on paper and governance-light in practice.
Clinical trial consent is collected once at enrollment it doesn't cover post-trial data use or follow-up research
Patient support program data is shared with CROs, KPOs, and field teams without mapped processor agreements
Prescription data analytics uses de-identified data that retains re-identification risk without assessment
Pharmacovigilance reporting involves sensitive health data with no documented consent basis or audit trail
Cross-border data transfers to global parent companies or CROs lack DPDP-compliant transfer mechanisms
Patient registries accumulate data indefinitely without retention schedules or deletion triggers
The ConsenPro Approach
Consent-backed data governance from clinical trial to patient support to pharmacovigilance.
ConsenPro maps your pharma data estate across clinical operations, patient programs, prescription analytics, and regulatory submissions. Consent is purpose-specific at enrollment trial participation, follow-up research, pharmacovigilance, and patient program participation are distinct consent events. CROs, KPOs, and field service organisations are mapped as data processors. Cross-border transfers to global affiliates are assessed and governed. Patient registries are subject to automated retention schedules. DSARs are aggregated across all clinical and patient-facing systems.
Capabilities
What ConsenPro delivers
Clinical Trial Consent Architecture
Consent at trial enrollment covers only the trial protocol follow-up research, biobanking, and secondary data use require fresh, separate consent events governed under distinct records.
CRO & Field Partner Governance
Contract Research Organisations, KPOs, and field medical teams are mapped as data processors. Agreements specify data categories, processing scope, and sub-processor obligations.
Prescription Data Risk Assessment
Prescription analytics data is assessed for re-identification risk. DPIA workflows trigger automatically when new prescription data sources or processing activities are introduced.
Pharmacovigilance Data Controls
Adverse event reporting involves sensitive health data. DPDP-compliant legal basis is documented per reporting obligation consent, legal compliance, or legitimate interest with full audit trails.
Cross-Border Transfer Governance
Data transfers to global affiliates, CROs, and regulatory authorities are assessed for DPDP compliance. Transfer mechanisms are documented, and recipient agreements are enforceable.
Patient Registry Retention Management
Automated retention schedules govern patient registry data. De-identification or deletion is triggered on schedule expiry with cryptographic deletion records for audit.
Outcomes
What you can expect
DPDP Coverage
DPDP Section 6 (consent)DPDP Section 9 (SPD safeguards)DPDP Section 16 (cross-border transfers)DPDP Section 8 (processor obligations)