1. Introduction

The amendment extends the QR code-based track-and-trace system to several high-risk categories of medicines, making it easier to verify their authenticity and trace their movement through the supply chain.

Under the revised provisions, all vaccines, antimicrobials, anti-cancer medicines, and narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985 have been included under Schedule H2. The move is part of the government’s broader effort to combat counterfeit and substandard medicines while improving regulatory oversight and patient safety through digital technologies.

2. Origin and Intent

The amended rules require manufacturers of the specified medicines to print or affix a barcode or Quick Response (QR) code on the primary packaging label. Where the primary package does not have sufficient space, the code may be placed on the secondary packaging. The QR code will enable regulators, distributors, healthcare providers and consumers to instantly verify a medicine’s authenticity using software applications or compatible scanning devices.

Each QR code must contain nine essential data elements: the unique product identification code, the proper and generic name of the drug, the brand name, the name and address of the manufacturer, the batch number, the date of manufacture, the expiry date, the manufacturing licence number, and details of excipients. By making this information digitally accessible, the system will improve traceability throughout the supply chain, facilitate faster verification, and support timely identification of counterfeit or defective products.

The expanded QR code framework also complements India’s ongoing efforts to modernise pharmaceutical regulation by promoting greater transparency, accountability and digital monitoring across the sector.

3. Significance of the Amendment

The inclusion of additional categories of medicines under Schedule H2 serves multiple public health and regulatory objectives.

For vaccines, digital traceability will strengthen confidence in immunisation programmes by ensuring that only genuine products reach healthcare facilities and beneficiaries. Anti-cancer medicines, which are often expensive and susceptible to counterfeiting, will benefit from improved authentication, helping protect patients receiving life-saving therapies.

The inclusion of antimicrobials supports India’s National Action Plan on Antimicrobial Resistance by strengthening oversight of medicine quality and reducing the circulation of substandard antibiotics that contribute to drug resistance. Bringing narcotic and psychotropic medicines under the QR code framework will also improve monitoring of their legitimate medical use while helping authorities reduce diversion, illegal distribution and misuse.

Overall, the amendment strengthens India’s pharmaceutical regulatory framework by leveraging digital technology to improve product verification and supply chain security.

4. Impact

The expanded traceability requirements will significantly improve the ability of regulators and supply chain stakeholders to verify the authenticity of medicines. Manufacturers will now be responsible for ensuring that eligible products carry machine-readable QR codes containing complete product information. Distributors, pharmacists, hospitals and consumers will be able to quickly confirm details such as batch number, manufacturing licence, manufacturing and expiry dates before dispensing or using the medicine.

The measure is expected to make it easier to identify counterfeit, diverted or substandard medicines, improve product recalls where necessary, and enhance post-market surveillance. It will also promote greater transparency across India’s pharmaceutical supply chain while increasing public confidence in the quality and safety of medicines available in the market.

5. Conclusion

The expansion of Schedule H2 marks another important milestone in India’s transition towards technology-enabled pharmaceutical regulation. By extending QR code-based traceability beyond selected medicines to critical therapeutic categories, the government is creating a stronger and more transparent system for monitoring the movement of medicines from manufacturers to patients.

The initiative strengthens efforts to combat counterfeit and substandard medicines, supports the National Action Plan on Antimicrobial Resistance, and enhances oversight of vaccines, anti-cancer medicines and controlled substances. As India continues to modernise its healthcare ecosystem, digital traceability will play a crucial role in improving medicine safety, facilitating efficient recalls, strengthening post-market surveillance, and building greater trust in the country’s pharmaceutical supply chain.

The initiative is in line with the Government’s continued efforts to strengthen the regulatory framework for drugs and medical products, promote transparency in the pharmaceutical supply chain, and safeguard global public health. This will also aid in the efforts of the Government towards a “Nasha Mukt Bharat”.