India – Domestic

v. 20 – Q4 2021

Market Executive Summary Ministry of Health is currently working on requirements for introducing QR code for traceability of drugs in the domestic market. Details of what will be encoded within QR code is not available at this time.

Draft amendments have been made to the Drugs and Cosmetics Act that regulates the import, manufacture, distribution and sale of drugs and cosmetics in India. The draft amendments (G.S.R 449(E)) include identification requirements as listed:

  • Packaging level: Case / Shipper, secondary packaging, primary packaging
  • Data elements: GTIN, Batch/Lot Number – AI (10), Expiration Date – AI (17), Serial Number – AI (21)

These are draft rules and shall apply 180 days after the publication of the final rule.

The August 8, 2019 draft amendment (G.S.R 567(E)) is under discussion. This amendment proposes that every active pharmaceutical ingredient manufactured or imported in India should bear a QR code on its label at each packaging level and include the following data elements: Unique product identification code, name of the API, brand name, name and address of manufacturer, batch number, batch size, date of manufacturing, date of expiry or retesting, serial shipping container code, manufacturing license number or import license number, special storage conditions required- if any.

India domestic requirements have been in discussion for several years.

Focus is on public procurement, with previous deadline of April 2019 postponed to April 2020: From 1st April 2020, all medicines purchased under the PPO to carry a 2D Barcode/QR code. The previous compliance date was April 2019. Details on the order are provided in the Summary below. Note: Serialisation is not part of the 1st April 2020 public procurement requirements for primary packaging.

End of 1-year transition period is April 2021.

Key Dates
  • April 2021: Updated compliance date (previously April 2019) for Public Procurement Order (PPO) 2017 is April 2020, but includes a transition time of one year = effective compliance date is April 2021
  • September 2019: Serialization is not part of the April 1, 2020 pubic procurement requirements for primary packaging. Meeting held in August 2019 to discuss new direction for drug exports.
  • April 2019: Public Procurement Order (PPO) of 2017.
  • March 2015: GS1 India and Indian Insurance Bureau sign a MOU to build a GLN registry for hospital management systems.
  • April 2014: Two federal states start implementing GS1 standards in drug procurement and hospital management systems.

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