Beyond Compliance: The Encrypted Anti-Counterfeit Solution for Pharma APIs
Fully compliant with CDSCO G.S.R. 20(E). Protect your Active Pharmaceutical Ingredients with military-grade encryption that standard QR codes cannot match.
The Regulatory Mandate
Mandatory QR Code Compliance for APIs
As per the Ministry of Health & Family Welfare's notification G.S.R. 20(E), effective January 1, 2023, all Active Pharmaceutical Ingredients (APIs) manufactured or imported in India must carry a Quick Response (QR) code on every level of packaging.
This landmark regulation aims to combat the growing menace of counterfeit and substandard pharmaceutical ingredients that pose serious risks to patient safety and public health. The Indian pharmaceutical industry, being the third-largest producer by volume globally, faces significant challenges from sophisticated counterfeiting operations that threaten both brand integrity and consumer welfare.
Non-compliance with these regulations can result in severe penalties including license suspension, hefty fines up to ₹10 lakhs, and potential criminal prosecution under the Drugs and Cosmetics Act. More critically, manufacturers risk losing their hard-earned reputation and market access, making compliance not just a legal obligation but a business imperative.
Three key regulatory guidelines for Pharma Manufacturers
1. CDSCO-Compliant, Non-Clonable Product Authentication
Cryptography and blockchain-enabled, non-clonable QR codes aligned with CDSCO amendments (G.S.R. 823(E) & G.S.R. 20(E)) for Schedule H2 drug formulations and APIs. Ensures secure authentication, eliminates liability risks related to spurious, adulterated, or relabelled drugs, and offers an affordable pathway to meet GMP and statutory compliance requirements.
2. Global Track & Trace With GS1 & Multijurisdictional Compliance
End-to-end serialization with parent–child packaging relationships fully compliant with export regulations (Public Notice No. 39-2023). Supports seamless data exchange with global regulatory systems including iVEDA (India), EMVO (EU), Tatmeen (UAE), NAFDAC (Nigeria), DSCSA (USA), ANVISA (Brazil), SFDA (Saudi Arabia), CRPT Russia, NMPA China, and others—providing a unified, GS1-compliant traceability infrastructure.
3. Regulatory-Aligned Recall & Market Action Management
Built-in recall workflows aligned with the Guidelines for Spurious, Adulterated, and Not-of-Standard-Quality Drugs under the Drugs & Cosmetics Act. Enables immediate inquiry, batch recall, sale stoppage, and corrective action for Category A and Category B defects to ensure rapid regulatory response and public safety.
What the law requires your label to show:
The Risk: Standard QR codes mandated by this law are static and easily cloned by counterfeiters. Compliance protects your license, but Ciphercode protects your product.
The Ciphercode Difference: "Cryptoblock" Technology
Don't Just Label. Secure.
While traditional vendors offer standard QR printing, Ciphercode.ai integrates Unit-Level Encryption. We turn a regulatory burden into a supply chain fortress.
Our proprietary Cryptoblock™ technology embeds multiple layers of cryptographic security into each QR code, making them mathematically impossible to duplicate or forge. Unlike static QR codes that can be photographed and reproduced, our dynamic encryption algorithms generate unique, time-sensitive codes that validate against our secure cloud infrastructure in real-time.
The pharmaceutical supply chain is complex, involving multiple stakeholders from raw material suppliers to distributors, wholesalers, and retailers. Each handoff represents a potential vulnerability point. Ciphercode creates an unbroken chain of custody by linking each transaction to blockchain-ready audit trails, ensuring complete transparency and accountability across your entire distribution network.
| Feature | Standard Compliance Vendors | Ciphercode.ai Solution |
|---|---|---|
| Security Level | Static QR (Easily Photocopied) | Cryptoblock™ Encrypted QR (Unclonable) |
| Verification | Visual / Basic Scan | Real-time Server Validation (Zero False Positives) |
| Data Integrity | Basic Label Data | Blockchain-ready Traceability |
| Authentication | Requires Specialized App | App-Free (Works with any Camera) |
Ciphercode PharmaSecure: End-to-End Traceability
Detailed Technical Breakdown
21 CFR Part 11 Compliant Software
Our cloud-native platform is built for regulated environments, meeting the stringent requirements of pharmaceutical manufacturing and ensuring full compliance with FDA electronic records and signatures standards.
- •Audit Trails: Immutable, tamper-proof logs of every code generated, printed, and scanned with timestamp, user ID, and action details. All records are encrypted and stored with redundancy for regulatory inspections.
- •User Access Control: Multi-tier role-based access management (RBAC) with granular permissions for plant operators, quality control teams, production managers, and administrators.
- •Digital Signatures: Secure approval workflows for batch release with multi-level authorization. Electronic signatures are legally binding and meet global regulatory requirements.
- •Data Integrity: ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) are embedded into every transaction.
Seamless ERP & Hardware Integration
We don't disrupt your production line. Ciphercode integrates seamlessly with your existing infrastructure through RESTful APIs, OPC-UA protocols, and standard database connectors.
- •ERP Systems: Native integration with SAP (HANA, S/4HANA, ECC), Oracle (E-Business Suite, Cloud), Microsoft Dynamics 365, and custom systems. Automatic batch data synchronization ensures real-time consistency.
- •Industrial Printers: Certified compatibility with leading thermal transfer and continuous inkjet printers including Domino, Videojet, Markem-Imaje, Zebra, and DataMax.
- •Vision Systems: Integration with Cognex In-Sight, Antares Vision, Siemens SIMATIC for automated print quality grading, OCR/OCV verification, and 100% inline inspection.
- •MES & SCADA: Direct connectivity to Manufacturing Execution Systems and SCADA platforms for real-time production monitoring and automated batch record generation.
Smart Serialization
Unlike simple sequential numbering that counterfeiters can easily predict and replicate, our advanced serialization engine generates cryptographically secure, randomized strings using military-grade algorithms.
- •Hierarchical Aggregation: Multi-level parent-child relationships from individual API containers through shipper cases, pallets, and full truckloads. Supports up to 5 levels of aggregation.
- •Intelligent Geo-Fencing: GPS-enabled supply chain monitoring with customizable zone definitions. Receive instant alerts if products deviate from authorized distribution routes.
- •Dynamic Code Generation: Real-time code generation synchronized with production speed, supporting batch sizes from small clinical trial quantities to large commercial batches of 10+ tonnes.
- •Chain of Custody Tracking: Complete visibility from manufacturing through distribution with timestamp precision for every custody transfer.
GS1 Global Standards Compliance
Future-proof your business with full GS1 compliance. Our system supports all major international serialization and traceability regulations, making global market access seamless.
- •US DSCSA Compliance: Ready for the Drug Supply Chain Security Act requirements with Transaction Information (TI), Transaction History (TH), and Transaction Statement (TS) generation.
- •EU FMD/Delegated Regulation: Compliant with European Falsified Medicines Directive including unique identifier generation and integration with European Medicines Verification System (EMVS).
- •GS1 DataMatrix & GTIN: Industry-standard 2D barcode format with embedded Global Trade Item Numbers. Supports ECC200 error correction for reliable scanning.
- •EPCIS Data Exchange: Electronic Product Code Information Services (EPCIS) 2.0 support for standardized supply chain event sharing with distributors and regulatory authorities globally.
Strategic Benefits
Transform regulatory compliance into competitive advantage. Ciphercode delivers measurable ROI through enhanced security, operational efficiency, and market differentiation.
For API Manufacturers
- ✓Zero Rejection Risk
Ensure 100% compliance with CDSCO G.S.R. 20(E) audits and avoid costly license suspensions, production shutdowns, or market recalls. Our system automatically generates audit-ready reports with complete traceability documentation.
- ✓Brand Protection & Market Differentiation
Prevent adulterated "fake" APIs from ruining your reputation with formulation clients. Differentiate your products with verifiable authenticity that commands premium pricing and builds long-term customer trust.
- ✓Export Market Access
Meet international serialization requirements for US, EU, and 50+ countries with a single platform. Expand your addressable market without multiple compliance investments.
- ✓Operational Excellence
Reduce manual documentation by 80% through automated batch record generation. Minimize human errors, accelerate batch release cycles, and optimize inventory management with real-time visibility.
- ✓Supply Chain Intelligence
Gain actionable insights into distribution patterns, identify bottlenecks, detect diversion activities, and optimize logistics costs through advanced analytics dashboards.
For Formulation Clients (B2B)
- ✓Instant Authenticity Verification
Your clients can verify raw material authenticity instantly upon goods receipt (GRN) using any smartphone camera, no specialized scanners, proprietary apps, or technical training required. Get real-time authentication results in under 2 seconds.
- ✓Digital Certificate of Analysis (CoA)
Link each QR code directly to the digital CoA with complete test results, specifications, and quality parameters. Eliminate paperwork delays, reduce data entry errors by 95%, and accelerate goods receipt processing.
- ✓Quality Assurance & Risk Mitigation
Protect your formulation business from substandard or counterfeit APIs that could compromise product quality, trigger regulatory actions, or result in costly batch rejections and recalls.
- ✓Supplier Performance Tracking
Monitor API supplier consistency, track batch-to-batch variations, identify quality trends, and make data-driven procurement decisions. Build a validated supplier database with complete traceability.
- ✓Regulatory Confidence
Demonstrate due diligence to regulatory inspectors with complete API traceability records. Simplify audits with instant access to supplier certifications, batch genealogy, and chain of custody documentation.
Implementation Process
A detailed "How it Works" roadmap to build confidence
From initial setup to full production deployment, our experienced implementation team guides you through each phase with minimal disruption to your operations. Average time to production: 4-6 weeks.
Data Integration & System Mapping
We map your complete API product catalog, master data, and batch management details to the Ciphercode Cloud platform. Our integration specialists work directly with your ERP system to establish automated data flows.
⏱ Timeline: 1-2 weeks | 👥 Your team: IT Manager, Production Planner
Code Generation & Template Configuration
Our cryptographic engine generates encrypted, serialized QR codes customized for each scheduled batch. We configure label templates meeting both G.S.R. 20(E) requirements and your specific packaging needs.
⏱ Timeline: 3-5 days | 👥 Your team: Packaging Manager, QA Lead
Printer Integration & Testing
Encrypted codes are transmitted securely via TLS 1.3 to your plant's existing thermal or inkjet printers. We conduct extensive print quality testing across your production speed range to ensure consistent readability.
⏱ Timeline: 1 week | 👥 Your team: Production Technician, Maintenance
Inline Verification & Quality Control
Integrated vision systems automatically verify print quality grading (ISO/IEC 15415 standards), data accuracy, and code readability at production line speeds. Defective labels are automatically rejected before reaching finished goods.
⏱ Timeline: 3-5 days | 👥 Your team: Quality Control, Line Operator
Aggregation & Hierarchy Setup (Optional)
Configure parent-child relationships to bundle individual API containers into shipper cases, pallets, and full truck loads. Streamlines warehouse operations and enables automated logistics tracking throughout the supply chain.
⏱ Timeline: 2-3 days | 👥 Your team: Warehouse Manager, Logistics
Batch Activation & Go-Live
Batches are "activated" in the secure cloud infrastructure upon dispatch, making them verifiable by your distribution partners and clients. Real-time monitoring dashboard provides complete visibility into serialization performance and supply chain movements.
⏱ Timeline: 1 day | 👥 Your team: Supply Chain Manager, IT Support
Post-Implementation Support
Training & Onboarding
Comprehensive training for operators, QA staff, and administrators with video tutorials and user manuals
24/7 Technical Support
Dedicated support team available round-the-clock for troubleshooting, system optimization, and urgent issues
Performance Monitoring
Quarterly business reviews with utilization analytics, ROI metrics, and continuous improvement recommendations
Ready to Secure Your Supply Chain?
Meeting the G.S.R. 20(E) mandate is just the starting line. Lead the industry with Ciphercode's anti-counterfeit intelligence.
Future Ready
Ciphercode is already compatible with the upcoming "Top 300 Brands" mandate and Drugs (Second Amendment) Rules, 2025 for labeling transparency. Stay ahead of regulatory changes with our continuously updated compliance platform.