The Indian government is expanding its QR code-based track-and-trace system across a wider range of critical pharmaceuticals, including vaccines, antimicrobials, anti-cancer drugs, and narcotic and psychotropic medicines, in a major step toward strengthening supply chain integrity and combating counterfeit products.

Announced by the Ministry of Health and Family Welfare (MoHFW), the revised framework amends the Drugs Rules, 1945 and extends Schedule H2 provisions to cover these high-risk medicine categories. The move significantly broadens India’s existing digital traceability infrastructure, which until now applied only to the top 300 pharmaceutical brands.

Under the updated rules, manufacturers will be required to apply a barcode or QR code on primary packaging labels, or on secondary packaging where space constraints exist. These codes will store key product data accessible via digital verification tools, enabling authentication across the entire pharmaceutical supply chain.

The embedded information will include a unique product identification code, brand and generic names, manufacturer details, batch number, manufacturing and expiry dates, licence information, and where relevant, excipient details. This enhanced data layer is designed to improve transparency, strengthen regulatory oversight, and enable real-time verification of medicine authenticity.

Policy aims: safety, transparency and anti-counterfeit enforcement

According to the government, the expanded system is intended to reduce the circulation of spurious and substandard medicines, which remain a persistent challenge in global pharmaceutical markets. By enabling digital verification at multiple stages of distribution, authorities aim to improve end-to-end traceability and reduce opportunities for counterfeit infiltration.

The initiative is also linked to public health priorities, particularly in addressing antimicrobial resistance (AMR). By improving the traceability of antimicrobials, regulators expect to strengthen monitoring of usage and quality, supporting more effective stewardship of these critical medicines.

Vaccine security and oncology drug integrity are also key focus areas, given their sensitivity, high value and complex cold-chain distribution requirements. The inclusion of narcotic and psychotropic drugs further reflects concerns around diversion, misuse and regulatory enforcement.

Phased implementation timeline

To support industry transition, the government has introduced staggered compliance deadlines. Requirements for vaccines, anti-cancer medicines, and narcotic and psychotropic drugs will take effect from July 1, 2027. Antimicrobials will follow later, with enforcement beginning on July 1, 2028.

This phased rollout is expected to give manufacturers, packers and distributors time to adapt packaging lines, integrate serialization systems, and upgrade digital infrastructure across production and logistics networks.

Implications for pharmaceutical packaging and supply chains

The expansion of QR-based traceability is expected to have significant implications for pharmaceutical packaging design and operations. Packaging lines will require enhanced serialization capabilities, improved data management systems, and closer integration with regulatory databases.

For packaging suppliers, this trend reinforces the growing importance of smart packaging technologies, including variable data printing, digital authentication systems, and secure label substrates capable of supporting high-density data encoding.

More broadly, the move reflects a global shift toward digitalised pharmaceutical supply chains, where packaging is increasingly viewed not just as a protective layer, but as a critical data carrier enabling safety, compliance and transparency.

Image suggestion: Close-up of pharmaceutical packaging with QR code scanning on vaccine vial or medicine carton in a hospital or pharmacy environment.