DSCSA-ready. ALCOA+ audit trail. EPCIS 2.0 export.
Pharma is the most regulated vertical we support. Every batch needs licence-validated origin, every audit row needs to survive a 21 CFR Part 11 inspection, and every recall has hours, not weeks. Qrynto ships the compliance addons to make all three routine.
Top 300
drug brands under India's Schedule H2 QR mandate since Aug 2023
10%
WHO estimate of substandard meds (LMIC)
21 CFR
Part 11 + ALCOA+ data integrity
Figures are from published reports — FICCI CASCADE / TARI (2022-23), OECD/EUIPO (2025), ASPA, WHO, and GS1 — shown for context.
The Problem
Why Pharmaceuticals Needs Product Authentication
Counterfeit Medicines Kill
Substandard or fake pharmaceuticals cause hundreds of thousands of deaths annually. Patient safety is non-negotiable.
DSCSA / Track-and-Trace Mandates
India's Schedule H2 rule has required QR codes on the top-300 drug brands since Aug 2023 — expanding to vaccines, anti-cancer and narcotic drugs from Jul 2027 and antimicrobials from Jul 2028, with GS1 GTINs required. US DSCSA and EU FMD add unit-level serialisation and event reporting. Generic QR platforms don't cover the regulatory gaps.
Audit Trail Must Be Tamper-Evident
21 CFR Part 11 and ALCOA+ require electronic records that are attributable, contemporaneous, and unalterable. A regular logs table fails inspection.
Recall In Hours, Not Weeks
A recall ETA over 72 hours triggers an FDA Form 483 finding. You need to know which units are dispensed, in transit, and at which partner — instantly.
The Solution
How Qrynto Solves This
Licence Enforcement
Hard-blocks batch creation when the manufacturing unit doesn't hold the required Drug Licence, GMP, or product-specific licences. Every batch path validated at INSERT time.
Tamper-Evident Audit Trail
Per-company SHA-256 hash chain on every audit row, sealed at INSERT via DB trigger. On-demand verifier proves no row was modified or reordered.
Decommissioning & Mass Recall
Pharmacist scans dispense individual units. Recall a batch and cascade to every active QR in one transaction — consumers see "do not use" on the public scan page instantly.
GS1 EPCIS 2.0 Export
Generate JSON-LD event reports — commissioning, shipping, aggregation, decommissioning — in the format DSCSA verifier tools and EU repositories ingest natively.
Lot Genealogy & Recall Impact
Trace a lot forward (every split, rework, shipment, dispense) and backward. Recall impact preview counts already-dispensed units and identifies descendant lots.
Per-Unit Serialisation
SGTIN-96 EPC URNs when products have GTINs. Cryptographic HMAC-SHA256 signature on every QR — counterfeit codes fail verification.
In the field
Use Cases
Prescription drugs
DSCSA unit serialisation and dispense reporting
OTC medicines
patient verification at point of sale
Vaccines
cold chain integration and lot traceability
Medical devices
UDI compliance and recall traceability
Biologics
high-value lot genealogy and audit trail
Inspector-ready compliance. Get in touch.
Book a demo tailored to pharmaceuticals and see how Qrynto protects your products.