Govt Mandates Barcodes on Key Drug Categories to Curb Counterfeits

In a decisive move to fight the growing threat of counterfeit medicines, the Indian government has changed the Drugs Rules, 1945 to require barcodes or QR codes to be required on the packaging of certain high-risk medications.

The requirement, which was notified on June 27, 2025, will apply to antimicrobials, vaccines, narcotic drugs, and psychotropic substances.

This requirement aims to increase the traceability of medicines while ensuring the identity of the product within the supply chain from manufacturer to consumers. The encoded information will contain information such as the unique identification code, batch number, manufacturing date, expiry date, and license number of the pharmaceutical product. Stakeholders, including pharmacists, distributor, hospitals, and consumers, will be able to review the information by barcode scanners.

This requirement is an extension of the barcode requirements for the top-selling cancer drugs as previously released; the reason for this as a drug safety requirement is for the broader public health risk related to fake and sub-standard medicines in the supply chain. According to industry experts, this requirement is a significant step toward digitalization of pharmaceutical regulation and instilling trust in India's drug supply chain.

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The industry accepts that there will be initial compliance challenges in implementing this procedure, especially for smaller manufacturers. Stakeholders view this policy as critical to ensuring patient safety, supporting regulatory transparency, and reinforcing India’s global reputation as a major pharmaceutical producer.