New Delhi: In a major move to strengthen drug safety and curb the circulation of counterfeit medicines, the Union Health Ministry has expanded its QR code-based track-and-trace system to cover vaccines, antimicrobials, anti-cancer medicines and narcotic and psychotropic drugs.
The ministry has notified amendments to the Drugs Rules, 1945, bringing these categories under Schedule H2, which mandates the use of barcodes or QR codes on medicine packaging for authentication and traceability across the supply chain.
Under the new rules, manufacturers will be required to print or affix QR codes on product packaging containing key information such as the drug’s generic and brand names, manufacturer details, batch number, manufacturing and expiry dates, licence number and other relevant data.
Officials said the move will enable easier verification of medicines, strengthen regulatory oversight and help prevent the distribution of counterfeit and substandard drugs. The initiative is also expected to support efforts to combat antimicrobial resistance and promote transparency in the pharmaceutical supply chain.
The QR code requirement was previously applicable only to the country’s top 300 pharmaceutical brands. The latest amendment significantly broadens its scope.
The new provisions for vaccines, anti-cancer medicines and narcotic and psychotropic drugs will come into effect from July 1, 2027, while compliance for antimicrobials will be mandatory from July 1, 2028. The government has encouraged manufacturers to adopt the system voluntarily before the deadlines.
