SF Prep Notes

QR code track-and-trace extended to all vaccines, antimicrobials, NDPS and anti-cancer drugs under Schedule H2

The Health Ministry said on 25 June 2026 that it has amended the Drugs Rules, 1945 to bring all vaccines, antimicrobials, NDPS drugs and anti-cancer drugs under Schedule H2, which requires a Bar Code or QR Code for authentication and traceability.

Summary

The Ministry of Health and Family Welfare said on 25 June 2026 that it has notified amendments to the Drugs Rules, 1945 bringing all vaccines, antimicrobials, narcotic and psychotropic drugs under the NDPS Act, 1985, and all anti-cancer drugs under Schedule H2. Schedule H2 requires a Bar Code or QR Code on the primary packaging label, or the secondary label where space is inadequate, for authentication and traceability across the supply chain. The QR Code must carry nine data elements, including the unique product identification code, batch number, dates of manufacture and expiry and the manufacturing licence number. The QR requirement earlier applied to the top 300 pharmaceutical brands, and the expansion is also meant to help the fight against antimicrobial resistance.

Key facts

Rule
Schedule H2, Drugs Rules, 1945
Now covered
All vaccines, antimicrobials, NDPS drugs, anti-cancer drugs
QR data
Nine data elements
Earlier
Top 300 pharmaceutical brands

Practice MCQs 2 questions

Q1 Advanced

In June 2026 the Health Ministry brought all vaccines, antimicrobials, NDPS drugs and anti-cancer drugs under the QR Code track-and-trace framework by amending which schedule of the Drugs Rules, 1945?

Show answer

Correct answer: C — Schedule H2

These categories were included under Schedule H2 of the Drugs Rules, 1945, which provides for a Bar Code or QR Code on packaging.

Q2 Advanced

Before the June 2026 amendment, the QR Code-based identification requirement under the Drugs Rules applied to:

Show answer

Correct answer: B — The top 300 pharmaceutical brands

The requirement for QR Code-based identification was earlier applicable to the top 300 pharmaceutical brands in the country.

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