Union Health Ministry Adds All Vaccines, Cancer Drugs to H2 Schedule for Strict Tracking & QR Codes

New Delhi: The Union Health Ministry has extended mandatory tracking and tracing requirements to all vaccines, antibiotics, cancer drugs and narcotic and psychotropic substances, expanding the anti-counterfeiting regime that was earlier only applicable to India’s top 300 selling drug brands.

Regulations issued under Schedule H2 of the Drugs Regulations 1945 require manufacturers to print them QR codes or barcodes, unique to each product, on packaging that allow regulators and consumers to verify product authenticity, lot details and manufacturing history by scanning.

The government has expanded this system to ensure that counterfeit products do not reach patients.

The implementation will take place in two different dates to give companies time to adapt. Provisions covering Vaccines, narcotics, psychoactive drugs and cancer drugs will take effect from July 1, 2027, while companies making antimicrobial drugs have until July 1, 2028 to comply, the ministry said in a gazette.

The aim of the expansion is to reduce the circulation of counterfeit and substandard medicines and to support India’s fight against antimicrobial resistance by improving the tracking of counterfeit or substandard antibiotic products throughout the supply chain.

“The current amendment significantly expands its coverage to include all vaccines, antimicrobials, anti-cancer drugs and narcotic and psychotropic drugs, thereby expanding the scope of traceability and strengthening safeguards against the circulation of counterfeit and substandard drugs,” the Ministry of Health said.

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The health ministry said the tracking mechanism will enable verification of the authenticity of drugs at various stages supply chain for monitoring and verification of medicinal products.

“The measures are expected to strengthen regulatory oversight and support efforts to curb the distribution of counterfeit drugs in the market,” the Ministry of Health said.

According to the rules, manufacturers must place a barcode or QR code on the label of the primary packaging or, in the absence of space, on the label of the secondary packaging. This code must contain detailed manufacturing data that software applications can read.

“The QR code will contain key product information including the unique product identification code, generic and trade names, manufacturer’s name and address, batch number, date of manufacture and expiry, manufacturing license number and details of excipients wherever possible,” the health ministry said. Excipients are inactive ingredients or substances formulated together with the active pharmaceutical ingredient (API) of the drug.