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In a major move to curb counterfeit medicines and improve drug traceability across the country, the Ministry of Health and Family Welfare (MoHFW) has proposed mandatory barcoding or Quick Response (QR) codes for all vaccines, antimicrobials, anticancer, and narcotic and psychotropic drugs. The proposal, outlined in a draft amendment to the Drugs Rules, 1945, was recently published for public feedback and aims to expand India’s pharmaceutical tracking framework beyond its existing Schedule H2 provisions .
What the Proposal Entails
The draft Drugs (Amendment) Rules, 2025, seek to widen the scope of Schedule H2 to include all drugs in the following categories:
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Vaccines used in immunization programs and clinical settings
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Antimicrobial agents, including antibiotics and antifungals
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Anticancer medications, both oral and injectable formulations
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Narcotic and psychotropic substances governed by the Narcotic Drugs and Psychotropic Substances Act, 1985
Each product will be required to carry either a barcode or a QR code on its label — preferably on the primary packaging. If the space is insufficient, labeling on the secondary package will be accepted. The codes will store essential data including the drug’s generic and brand names, unique product identification code, batch number, manufacturer details, manufacturing and expiry dates, among other regulatory identifiers .
The Ministry has invited public objections and suggestions within 30 days of the draft notification’s release. Written feedback can be submitted to the Director (Drugs Regulation), MoHFW, or via email to [email protected].
Strengthening Drug Safety and Traceability
According to the MoHFW, this measure is an extension of the Drugs (Eighth Amendment) Rules, 2022, which came into effect on August 1, 2023. That amendment introduced QR-based traceability for 300 drugs listed under Schedule H2, including widely used formulations like metformin, atorvastatin, and azithromycin.
Expanding this mechanism to all vaccines and critical drug categories represents an attempt to establish a comprehensive “track and trace” network across the Indian drug supply chain. The initiative aims to enhance transparency, prevent diversion of narcotic substances, and protect patients from substandard or counterfeit products — a problem that, according to the World Health Organization (WHO), affects an estimated one in ten medical products in low- and middle-income countries.
Dr. Rakesh Kumar, a regulatory affairs expert and former consultant to the Central Drugs Standard Control Organization (CDSCO), emphasized the public health implications:
“Introducing universal barcoding is a critical step towards real-time monitoring and accountability in pharmaceutical logistics. It will not only safeguard patients but also strengthen India’s credibility as a global drug manufacturer,” he said.
Industry Reactions and Implementation Challenges
While the pharmaceutical industry broadly supports digital transparency, the proposal may pose logistical and cost-related challenges for small and medium-scale drug manufacturers. Implementing new labeling technology requires investment in specialized printing equipment and data management software.
Dr. Meena Reddy, Professor of Pharmaceutical Quality Assurance at the National Institute of Pharmaceutical Education and Research (NIPER), warns that smaller firms may struggle to comply without government support:
“Compliance mechanisms like barcoding improve accountability, but capacity-building programs and subsidies may be necessary to ensure uniform implementation across all manufacturers,” she noted.
Past experiences show that large-scale traceability programs require coordination between regulators, manufacturers, distributors, and pharmacists. In India’s vast supply chain, where millions of medicine batches move across hundreds of distribution channels daily, ensuring consistent code readability and data integration will be critical.
Context: Expanding on Earlier Steps
The idea of using QR codes for drug monitoring isn’t new. The Drug Technical Advisory Board (DTAB) had already approved such mechanisms for oncology products during its 91st meeting in August 2024 . The expansion to all critical drug categories marks the next phase of India’s digital regulatory transformation under the Drugs and Cosmetics Act, 1940.
Globally, countries like the United States, members of the European Union, and China have already adopted similar serialization systems under the Drug Supply Chain Security Act (DSCSA) and other frameworks. These international models demonstrate the potential of digital labeling to reduce counterfeiting, increase recall efficiency, and improve pharmacovigilance.
Implications for Healthcare Providers and Consumers
For healthcare professionals, barcoded medicines could simplify drug authentication, help prevent medication errors, and improve prescription tracking. Pharmacists may be able to verify origin data instantly through handheld scanners or smartphone apps, minimizing the risk of dispensing falsified drugs.
For consumers, improved traceability could promote trust and safety in medicine purchases — especially for online pharmacy transactions, which have surged in India post-pandemic.
“Digital labeling enhances transparency at every stage — from manufacturing to dispensing. It means consumers will soon be able to confirm a medicine’s authenticity with a simple scan,” said Dr. Anjali Bhatnagar, a clinical pharmacologist at AIIMS, New Delhi.
Potential Limitations and Next Steps
Despite its promise, experts caution that technology alone cannot ensure drug safety. Effective enforcement, regular audits, and cybersecurity safeguards will be essential to prevent misuse of tracking data. Moreover, interoperability between national and state-level drug monitoring systems must be prioritized to prevent data silos.
Once finalized, the new amendment will come into force from a date specified in the official gazette. The government plans to issue detailed implementation guidelines in consultation with the Central Drugs Standard Control Organization (CDSCO) and industry stakeholders.
If successfully enforced, India could become one of the few countries with a unified digital framework for tracking all vaccines and high-risk drugs — setting a global standard for pharmaceutical accountability and patient safety.
Medical Disclaimer:
This article is for informational purposes only and should not be considered medical advice. Always consult with qualified healthcare professionals before making any health-related decisions or changes to your treatment plan. The information presented here is based on current research and expert opinions, which may evolve as new evidence emerges.
References:
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Medical Dialogues. “Health Ministry Proposes Barcoding Rule for All Vaccines, Antimicrobials, Anticancer, and Narcotic Drugs.” Published October 2025 . https://medicaldialogues.in/news/industry/pharma/health-ministry-proposes-barcoding-rule-for-all-vaccines-antimicrobials-anticancer-and-narcotic-drugs-157343
