In a decisive move against the growing menace of counterfeit medicines, the Indian government is preparing to mandate barcodes or QR codes on the packaging of antimicrobials, vaccines, psychotropic substances, and narcotics. The upcoming amendment to the Drugs Rules, 1945, aims to enhance drug traceability and safeguard patient safety.

Key highlights

New barcode mandate for high-risk drugs

• Barcode or QR code labels will soon be compulsory on antimicrobials, vaccines, narcotics, and psychotropic substances.

• The Union Health Ministry is set to notify the rule changes based on recommendations from the Drugs Consultative Committee (DCC).

Previous barcode use on top brands

• Barcode tracking is already in place for 300 high-selling drugs like Dolo, Calpol, Ecosprin, Limcee, and Fabiflu.

• Scanning provides key data such as manufacturing license, batch number, and expiry details.

Push despite industry opposition

• Pharma stakeholders raised concerns over scanning rates and infrastructure costs.

• However, the DCC dismissed these concerns as non-substantial in light of public interest.

Triggered by anti-cancer drug scams

• The move follows alarming cases of counterfeit anti-cancer drugs being refilled in original vials and sold to patients.

• Barcodes on anti-cancer drugs were made mandatory earlier to fight this racket.

Implementation long in the works

• India first proposed QR codes in 2011, but faced multiple delays due to industry resistance.

• The policy gained momentum in 2023 after cases of counterfeit drugs prompted regulatory action.

With the rollout of mandatory barcodes across more critical medicines, the Indian pharma supply chain is set to become more transparent and traceable. For retailers and pharmacists, this means greater responsibility and also a more secure environment for patient care.