In a landmark move to strengthen drug traceability in India the Union Ministry of Health and Family Welfare has notified amendments to the Drugs Rules, 1945. These amendments significantly expand the ambit of Schedule H2, bringing additional categories of critical drugs under the QR code-based drug track-and-trace framework.

What Has Changed in India’s Drug Traceability Rules Under Schedule H2?

Previously, the QR code-based identification requirement was applicable only to the top 300 pharmaceutical brands in the country. Under the amended provisions, the government has now expanded this coverage to include four major categories of drugs:
  1. All vaccines
  2. All antimicrobials (including antibiotics)
  3. All anti-cancer medicines
  4. Narcotic and psychotropic drugs covered under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985
This expansion marks a significant broadening of the traceability framework, extending safeguards against counterfeit and substandard medicines to entire categories of drugs considered critical from a public health perspective.

How Will the QR Code Drug Traceability System Work in India?

Under the amended rules, manufacturers of these drug formulations will be required to print or affix a Bar Code or Quick Response (QR) Code on the primary packaging label of the product. Where there is inadequate space on the primary packaging, the code can be placed on the secondary packaging label. The QR Code will be accessible through software applications and will carry nine key data elements for each drug product:
  1. Unique product identification code
  2. Proper and generic name of the drug
  3. Brand name
  4. Name and address of the manufacturer
  5. Batch number
  6. Date of manufacture
  7. Date of expiry
  8. Manufacturing licence number
  9. Details of excipients (inactive ingredients)
This comprehensive set of information will facilitate seamless verification and tracking of medicines across the entire supply chain, from manufacturing to distribution to the end consumer.

Why Are Vaccines, Antimicrobials, and Anti-Cancer Medicines Covered Under the QR Code Framework?

The government has strategically chosen these categories for several compelling reasons:
Public Health Priority
Vaccines, antimicrobials, and anti-cancer medicines are critical to public health. Counterfeit or substandard versions of these drugs can have devastating consequences, particularly for cancer patients whose treatment depends on timely access to genuine, quality-assured medicines.
Combatting Antimicrobial Resistance (AMR)
The inclusion of antimicrobials is expected to contribute significantly to the national fight against Antimicrobial Resistance. Better traceability will help identify and monitor counterfeit and substandard antimicrobial products, which contribute to inappropriate treatment and drug resistance.
Curbing Misuse of Narcotic Drugs
Bringing NDPS drugs under this framework will help track and authenticate the supply chain of these controlled substances, supporting the government’s efforts towards a “Nasha Mukt Bharat” (Drug-Free India).
Schedule H2 QR Code Compliance Timelines: What Pharma Companies Need to Know
Recognising the need to provide adequate time to the industry and other stakeholders for implementation, the Ministry has prescribed phased timelines for compliance:
  • July 1, 2027: Provisions relating to vaccines, narcotic and psychotropic drugs, and anti-cancer medicines shall come into force
  • July 1, 2028: Provisions relating to antimicrobials shall become effective
Manufacturers are encouraged to undertake voluntary early adoption of these provisions prior to the notified dates to accelerate the benefits of enhanced drug authentication, traceability, and supply chain transparency.

Expected Impact of QR Code Drug Traceability on India’s Healthcare and Pharmaceutical Sector

The enhanced traceability mechanism is expected to deliver multiple benefits:
  • Strengthened Regulatory Oversight: Improved tracking and verification of drug products will help regulators identify counterfeit and substandard products more effectively
  • Patient Safety: Healthcare providers and patients will be able to verify the authenticity of medicines more easily, providing greater confidence in the quality of drugs being administered
  • Global Pharmaceutical Leadership: The initiative aligns with India’s continued efforts to strengthen the regulatory framework for drugs and medical products, promoting transparency in the pharmaceutical supply chain and safeguarding global public health

Conclusion

This expansion of the QR code framework represents a significant step forward in India’s fight against counterfeit medicines. While experts note that QR codes are not a complete solution as they can potentially be copied, the measure substantially improves tracking and verification capabilities. The move also addresses broader concerns about medicine affordability and access. As some experts point out, addressing the root causes that create demand for medicines sold outside regulated channels, such as high medicine prices, remains crucial for comprehensive reform. The expansion of Schedule H2 to include these critical drug categories demonstrates the government’s commitment to ensuring that every Indian has access to safe, authentic, and high-quality medicines. As the implementation dates approach, the pharmaceutical industry, healthcare providers, and patients alike can look forward to a more transparent and secure pharmaceutical supply chain.

This post is contributed by:

Rishita Yadav

Fifth year, SLS Noida (Intern at Kngtechlaw)
 

About K&G Techlaw

As a leading healthcare tech law firm in India, we specialise in corporate, commercial and tech law with a special focus on pharmaceutical, healthcare and life sciences. We provide pharmaceutical regulatory compliance support India, healthcare legal advisory, and general corporate consultations. As a trusted drug traceability legal consultant India, we assist pharmaceutical and healthcare companies in navigating complex policy shifts, legal amendments, and regulatory enforcement matters including Schedule H2, QR code compliance, and drug labelling requirements.
Reference notification

Tags: QR Code Drug Traceability, Schedule H2, Drug Traceability India, Counterfeit Medicines India, Drugs Rules 1945 Amendment, Antimicrobial Resistance India, Pharma Regulatory Compliance

FAQS:

Under the amended Drugs Rules, 1945, manufacturers of specified drug categories must print or affix a QR code or barcode on the primary (or secondary) packaging of their products. The QR code must encode nine mandatory data elements including batch number, expiry date, manufacturer details, and manufacturing licence number, enabling end-to-end drug traceability across the pharmaceutical supply chain in India.

The amended rules expand mandatory QR code drug traceability beyond the earlier top-300-brands requirement to cover all vaccines, all antimicrobials (including antibiotics), all anti-cancer medicines, and narcotic and psychotropic drugs regulated under the NDPS Act, 1985. These categories have been prioritised due to their critical importance to public health and patient safety.

The Ministry has notified a phased implementation: manufacturers of vaccines, anti-cancer medicines, and narcotic/psychotropic drugs must comply by July 1, 2027, while manufacturers of antimicrobials have until July 1, 2028. Early voluntary adoption is encouraged by the government to accelerate the benefits of the track-and-trace framework.

The QR code on each drug pack allows regulators, healthcare providers, and patients to instantly verify the authenticity, origin, and supply chain journey of a medicine. By encoding nine key data points per product, the system makes it significantly harder for counterfeit or substandard drugs to enter the market undetected, thereby strengthening patient safety and pharmaceutical supply chain integrity across India.

The Schedule H2 QR code requirement applies to all manufacturers of the specified drug categories, both existing and new, who produce vaccines, antimicrobials, anti-cancer medicines, or NDPS drugs for the Indian market. All such manufacturers must ensure their packaging is compliant before the respective notified dates, regardless of when they received their manufacturing licence.