India mandates QR codes on vaccines, cancer drugs to fight counterfeits
The Union Health Ministry has expanded the requirement for QR code-based tracking on medicines to include vaccines, antimicrobials, narcotic drugs, and anti-cancer drugs. The move aims to curb the distribution of counterfeit and substandard medicines in the country.
Under amendments to the Drugs Rules, 1945, manufacturers of these drugs must now print or affix a QR code on the primary or secondary packaging. The code will store key product information such as batch number, manufacturing and expiry dates, manufacturer details, and a unique product identification code. This will allow authentication and verification of medicines at every stage of the supply chain.
Earlier, the QR code requirement applied only to the top 300 pharmaceutical brands. The new rules significantly broaden the scope of traceability. The ministry stated that the measure will strengthen regulatory oversight and help fight antimicrobial resistance (AMR) by better identifying counterfeit antimicrobial products.
The ministry has provided phased timelines for compliance. For vaccines, narcotic and psychotropic drugs, and anti-cancer medicines, the rules come into force from July 1, 2027. For antimicrobials, the deadline is July 1, 2028.
In a separate move, the ministry also notified amendments to the Clinical Establishments (Registration and Regulation) Act, 2010, on June 22, 2026. These reforms aim to reduce the compliance burden, improve ease of doing business, and replace criminal penalties for procedural lapses with a fair administrative mechanism. The changes include a structured adjudication process with an opportunity for hearing before penalties, and an appeal framework.
The ministry said the reforms promote trust-based governance while ensuring patient safety and quality of healthcare services.
