- Why in news
- On 25 June 2026 the Union Health Ministry notified amendments to the Drugs Rules, 1945. They add all vaccines, antimicrobials, NDPS drugs and anti-cancer drugs to Schedule H2, which requires a QR Code for track and trace.
- What it is
- The Drugs Rules, 1945 are made under the Drugs and Cosmetics Act, 1940. They regulate the import, manufacture, sale and distribution of drugs in India. Schedule H2 is the part of the Rules that lists drugs whose labels must carry a Bar Code or QR Code for authentication.
- Rules amended
- The Drugs Rules, 1945 were amended to widen Schedule H2.
- Newly covered drugs
- Vaccines, antimicrobials, NDPS Act narcotic and psychotropic drugs, and anti-cancer drugs now fall under Schedule H2.
- Where the code goes
- Manufacturers must put the code on the primary packaging label, or on the secondary label if space is short.
- Earlier coverage
- Earlier the QR Code rule applied only to the top 300 pharmaceutical brands.
- Phased dates
- Vaccines, narcotic and psychotropic drugs and anti-cancer drugs: 1 July 2027. Antimicrobials: 1 July 2028.
- Parent law
- The Drugs Rules, 1945 are framed under the Drugs and Cosmetics Act, 1940.
Don’t confuse with Schedule H vs H1 vs H2: Schedule H and H1 deal with prescription-only drugs. Schedule H2 here is the list requiring a QR Code for track and trace.
Don’t confuse with Drugs Rules, 1945 vs Drugs and Cosmetics Act, 1940: The Act is the parent law passed by Parliament. The Rules are subordinate legislation made under it by the Centre.
Laws, judgments and statutory bodies: 30 Prelims questions since 2013 (what the law says, who chairs, legal basis). In Mains, 44 news-triggered questions, most in GS2, asking for provisions and challenges.
Why it matters
- Helps authenticate medicines across the supply chain and curb spurious and substandard drugs.
- Supports the fight against antimicrobial resistance and misuse of narcotic drugs.
Problems
- Compliance cost and packaging changes for small manufacturers.
- Consumers, chemists and regulators need apps and digital capacity to verify codes.
Way forward
- Keep the phased timelines and build a common verification platform.
- Support MSME manufacturers and train retailers and inspectors.
- 2013Mains GS3 · Q14Meaning, merits and demerits of Fixed Dose Drug Combinations
- 2014Mains GS3 · Q11Free antibiotic availability causing drug resistance; mechanisms for monitoring and control
UPSC’s own questions that come close to this issue, from our Prelims and Mains banks.
Prelims practice · Statements
Ours, not from a UPSC paper
Consider the following statements:
- 1.Before this amendment, the QR Code requirement under the Drugs Rules, 1945 applied to the top 100 pharmaceutical brands.
- 2.Under the amendment, a manufacturer may put the Bar Code or QR Code on the secondary packaging label where the primary label has inadequate space.
- 3.The provisions for antimicrobials come into force on 1 July 2027, the same date as those for vaccines.
Which of the statements given above is/are correct?
True or false?
1 of 6
Statements the way Prelims prints them. Say first, then see the fact.
1.The amendment places all vaccines under Schedule H2 of the Drugs Rules, 1945.
True. Vaccines, antimicrobials, NDPS drugs and anti-cancer drugs are now in Schedule H2.
2.Where the primary label has inadequate space, the code may be placed on the secondary packaging label.
True. Secondary label is the fallback when primary space is inadequate.
3.The provisions for antimicrobials take effect on 1 July 2027, together with those for vaccines.
False. Antimicrobials take effect on 1 July 2028; vaccines on 1 July 2027.
4.The QR Code is meant to carry details such as batch number, expiry date and manufacturing licence number.
True. The code carries batch, dates, licence number, manufacturer and similar details.
5.The Drugs Rules, 1945 are framed under the Drugs and Cosmetics Act, 1940.
True. The Drugs and Cosmetics Act, 1940 is the parent Act.
6.The measure is also expected to help the fight against Anti-Microbial Resistance by curbing counterfeit antimicrobials.
True. Better identification of counterfeit and substandard antimicrobials supports the AMR fight.
Written by us from the release, not by UPSC; checked by a second model.
Worth revising until Prelims 2028: most news questions come within two years of the event.