New QR code track-and-trace system to crack down on fake medicines

📌 Summary:

• The Centre has mandated that all vaccines, antimicrobials, narcotics/addictive drugs and anti-cancer drugs carry a bar code or QR code enabling tracking of each vial/blister pack from manufacturing plant to retail store
• Already applied to the top 300 drug brands (e.g., Aciloc, Calpol); the new categories roll out by July 2027 (vaccines, narcotics, anti-cancer) and July 2028 (antimicrobials)
• Manufacturers of drugs under Schedule H2 of the Drugs Rules, 1945 (created four years ago) must affix a unique code on the primary package (or secondary if space is short)
• The code carries: unique identification number, brand and generic name, manufacturer name/address, batch number, manufacturing and expiry dates, and licence number; firms must log products on specialised track-and-trace platforms
• How it curbs counterfeiting: each unique code cannot be re-registered, so reusing original packaging to refill counterfeit drugs fails; helps regulators distinguish cost-cutting spurious manufacture from fully fake products and locate source-level contamination/tampering
• Counterfeiting forms targeted: drugs with no active ingredient, or diluted drugs sold in larger quantities

🎯 UPSC Relevance: GS2 (Governance/Health) — drug regulation and patient safety, supply-chain traceability/e-governance, and strengthening regulatory oversight (CDSCO) against spurious medicines.

📝 Prelims Facts:

• Schedule H2 of the Drugs Rules, 1945 lists the 300 top brands (now plus four new categories) requiring track-and-trace
• Track-and-trace already live for top 300 brands; new categories phased in by July 2027 and July 2028
• Code must carry batch number, manufacturing/expiry dates and the manufacturing licence number
• Drug regulation in India is governed by the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 (regulator: CDSCO)

🔑 Key Term: Track-and-trace — a system assigning each unit a unique serialised code logged on a digital platform, allowing every package to be followed across the supply chain to authenticate it and detect counterfeits.