India’s pharmaceutical industry is undergoing a major regulatory transformation. From QR codes on top-selling formulations to upgraded export traceability systems, the government is pushing for a safer, more transparent, and digitally verifiable pharma ecosystem.
While the regulatory journey has seen consultative phases, technical iterations, and deadline extensions, the direction is unmistakable:
India is moving toward a globally aligned, fully traceable pharmaceutical supply chain.
In this transition, Holostik, India’s leading anti-counterfeiting and phygital security solutions provider, is playing a pivotal role. Our solutions are used by some of the country’s largest pharma OEMs, exporters, and domestic brands to meet the rising standards of compliance, consumer safety, and supply-chain integrity.
2023–2025: QR Codes, Digital Transparency & India’s Traceability Leap Forward
In 2023, the Indian government mandated GS1-based QR codes for the top 300 drug formulations. This ensures:
- Unique serialization
- Traceability up to the consumer
- Better recall and enforcement readiness
- Protection against spurious and tampered medicines
Simultaneously, India’s export compliance platform, iVEDA, continued to evolve. Deadlines were extended (Aug 2023 → Feb 2024) not to delay progress, but to ensure the system is robust, technically aligned, and globally interoperable.
The API QR Code Rule (Jan 2023) added another layer of upstream security, ensuring traceability begins at the raw material stage.
These reforms set the stage for a digital-first, data-verified Indian pharma ecosystem.
2018–2022: The Regulatory Alignment Phase
Between 2018 and 2022, the government conducted extensive consultations on:
- Barcoding of top 300 domestic brands
- Standardising data models
- API identification
- Harmonising export and domestic serialization
These years represented thoughtful groundwork ensuring India’s system is not only modern but sustainable, scalable, and globally aligned.
2015–2018: India’s First Serialization Milestone
India’s first major leap began in 2015, when exporters were required to implement barcodes on secondary and tertiary packaging.
This early move:
- Introduced GTINs
- Familiarized Indian exporters with serialization
- Established digital reporting norms
Though DAVA had limitations, it initiated the culture of pharmaceutical traceability in India.
How Holostik Supports This Regulatory Journey?
India’s regulatory progress is meaningful only when companies can implement compliance practically, securely, and at scale.
This is where Holostik’s integrated phygital ecosystem creates unmatched value.
Holostik’s Physical Security for Compliance
Physical security features are not merely branding tools, they are mandatory compliance enablers in regulated pharma markets. They help pharma companies meet requirements related to:
- Tamper-evident packaging, which aligns with global expectations (EU FMD, WHO GMP)
- Supply-chain integrity, ensuring packs are not replaced or adulterated
- Visual authentication, assisting inspectors, distributors, and end-users
- Anti-counterfeiting protection, supporting legal and audit frameworks
Holostik provides pharma brands with best-in-class physical security, including:
Next-Generation Holograms
Multi-level, overt and covert 4th Gen NOI holographic features that help regulators and supply-chain partners instantly verify authenticity.
Tamper-Evident Security Labels
Designed to show visible evidence of interference — critical for maintaining pack integrity and ensuring compliance with tamper-evidence norms.
Holographic Blister Films & Foils
These strengthen API and formulation-level security, adding both anti-copy protection and visual authentication.
High-Security Holographic Packaging Films
Advanced holographic packaging films that integrate visible and covert security elements, ensuring strong protection against duplication and supply-chain diversion.
Holostik’s expertise in physical security is a direct enabler of pharmaceutical regulatory compliance and remains essential even in an increasingly digital world.
Holostik’s GS1-Certified Digital Solutions
India’s transition toward QR-based verification and global-standard traceability is driven by data integrity, interoperability, and GS1 adherence.
Holostik supports this through:
GS1-Certified Serialization & UID Generation
Ensuring every pack meets India’s QR rules and aligns with export requirements.
End-to-End Track & Trace Platforms
Providing visibility from manufacturing to patient, aligned with evolving domestic and export traceability mandates.
Integration with ERP, CRM & Manufacturing Lines
Critical for regulatory reporting, aggregation, and audit readiness.
Authentication & Consumer Verification
Users can verify a medicine instantly through QR scan — supporting India’s shift toward consumer-level safety.
Supply Chain Intelligence
Holostik systems offer dashboards for anomaly alerts, inspections, and recall efficiency.
Together, these capabilities ensure pharma manufacturers remain compliant today — and future-ready as India accelerates toward deeper serialization and verification frameworks.
Holostik’s Phygital Advantage: Why It Matters for India’s Regulatory Future
Regulations are moving toward a world where physical security + digital traceability work as one unified compliance fabric.
Holostik’s unique strength is its ability to combine:
- Physical authentication
- Digital verification
- Serialized identification
- Track-and-trace intelligence
This integrated phygital approach is precisely what India needs as it moves toward:
- Wider QR mandates
- Aggregation-level serialization
- National-level verification platforms
- Global interoperability
- Strict anti-counterfeit enforcement
Holostik stands not just as a solutions provider but as a regulatory partner, enabling pharma companies to meet evolving compliance demands without operational disruption.
India is Building a Globally Respected Traceability Ecosystem & Holostik is Helping Power it
The past decade of regulatory reform, from early barcodes to QR codes, from DAVA to iVEDA, from API traceability to domestic serialization — reveals one truth:
India is becoming one of the world’s most forward-looking pharmaceutical compliance markets.
As this transformation continues, pharma companies will need partners who bring:
- Deep regulatory understanding
- Proven physical security
- GS1-certified digital capability
- Scalable implementation experience
- Future-ready traceability technology
Holostik is committed to supporting this journey with world-class phygital security solutions that protect brands, safeguard patients, and strengthen India’s position as a trusted global pharma leader.