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India Regulatory

INDIA DRUG BARCODING REQUIREMENTS

 

REGULATORY AGENCY

India Ministry of Commerce and Industry, Department of Commerce, Directorate General of Foreign Trade (DGFT)

REGULATION NAME

Track and Trace System for Export of Pharmaceuticals and Drug Consignments

COMPLIANCE DATES

The date of implementation of Track and Trace system for export of drug formulations with respect to maintaining the Parent-Child relationship in packaging levels, and its uploading on Central Portal has been extended to 01.02.2025   SSI manufactured drugs.

APPLIES TO

Drug manufacturers who have manufacturing and/or packaging facilities within India, and who export drugs to any other countries.

SECONDARY PACKAGING

(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)

 

BARCODE SYMBOLOGY
Linear, or 2D Datamatrix following GS1 standards
BARCODE CONTENTS
  • GTIN
  • Serial number
  • Batch number
  • Expiry date

SERIAL NUMBER RANDOMIZATIONNo
SERIAL NUMBER REUSE

Not Specified

HUMAN READABLE EXPIRY DATE FORMAT

YYMMDD

BARCODE DATA ENCODING

GS1 Standards

PRODUCT CODE NOTES

In the case of “mono cartons”, a manufacturer or exporter shall affix the bar code on mono cartons containing one primary pack on an optional basis until further notice

FREE SAMPLES MUST BE MARKED?

Not Specified

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)

 

BARCODE   SYMBOLOGYGSl -128linearblank
BARCODE CONTENTSProduct code (use of the GS1 GTIN is now optional), Lot Number,Expiration Date, GS1 SSCC (SSCC may appear in a separate barcode)

AGGREGATION DATA CAPTURE

 

PARENT-CHILD MAPPING AGGREGATION CAPTURE?

 
Not Specified

DATA EXCHANGE

 

SEND UNIT DATA TO GOVERNMENT REPOSITORY?
Yes
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?

As applicable

SEND UNIT DATA TO TRADING PARTNER?

As applicable

SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY?
Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?

As applicable

SEND AGGREGATION DATA TO TRADING PARTNER?

As applicable

AUTHENTICATION

 

WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?

Government (iVeda for now)

MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?

Yes (Exports)

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?

No (Future)

DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT?
No

GOVERNMENT REPORTING

 

MANUFACTURER ACTIVITY REPORTED?Yes
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?

No

INDIA DRUG BARCODING REQUIREMENTS

 
REGULATORY AGENCY

The Central Drugs Standard Control Organisation (CDSCO)
REGULATION NAME

Drugs (Amendment) Rules, 2022
COMPLIANCE DATES

The new requirements will come into force on 1 January 2023.
APPLIES TO

Every API manufactured or importers

PRIMARY PACKAGING

(Packaging which is in direct physical contact with the active ingredient)
 
BARCODE SYMBOLOGY As per the GS1 standards
BARCODE CONTENTS
  • Unique product identification code (GTIN No.)
  • Name of the API,
  • Brand name (if any),
  • Name and address of the manufacturer,
  • Batch no.,
  • Batch size,
  • Date of manufacturing,
  • Date of expiry or retesting,
  • Serial shipping container code,
  • Manufacturing licence no. or import licence no.
  • Special storage conditions required (if any).
SERIAL NUMBER RANDOMIZATION No
SERIAL NUMBER REUSE

Not Specified
HUMAN READABLE EXPIRY DATE FORMAT

YYMMDD
BARCODE DATA ENCODING

GS1 Standards
PRODUCT CODE NOTES

QR code on its label at each level of packing that stored the data to facilitate tracking and tracing
FREE SAMPLES MUST BE MARKED?

Not Specified

SECONDARY PACKAGING

(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
 
BARCODE SYMBOLOGY As per the GS1 standards
BARCODE CONTENTS
  • Unique product identification code (GTIN No.)
  • Name of the API,
  • Brand name (if any),
  • Name and address of the manufacturer,
  • Batch no.,
  • Batch size,
  • Date of manufacturing,
  • Date of expiry or retesting,
  • Serial shipping container code,
  • Manufacturing licence no. or import licence no.
  • Special storage conditions required (if any).
SERIAL NUMBER RANDOMIZATION No
SERIAL NUMBER REUSE

Not Specified
HUMAN READABLE EXPIRY DATE FORMAT

YYMMDD
BARCODE DATA ENCODING

GS1 Standards
PRODUCT CODE NOTES

QR code on its label at each level of packing that stored the data to facilitate tracking and tracing
FREE SAMPLES MUST BE MARKED?

Not Specified

TERTIARY PACKAGING

(A shipper containing one or more secondary packs)
 
BARCODE   SYMBOLOGY As per GS1 standard blank
BARCODE CONTENTS GS1-128 (SSCC)
  • Unique product identification code (GTIN No.)
  • Name of the API,
  • Brand name (if any),
  • Name and address of the manufacturer,
  • Batch no.,
  • Batch size,
  • Date of manufacturing,
  • Date of expiry or retesting,
  • Serial shipping container code,
  • Manufacturing licence no. or import licence no.
  • Special storage conditions required (if any).

AGGREGATION DATA CAPTURE

 
PARENT-CHILD MAPPING AGGREGATION CAPTURE?
 Not Specified

DATA EXCHANGE

 
SEND UNIT DATA TO GOVERNMENT REPOSITORY? Yes
SEND UNIT DATA TO THIRD-PARTY REPOSITORY?

As applicable
SEND UNIT DATA TO TRADING PARTNER?

As applicable
SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY? Yes
SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY?

As applicable
SEND AGGREGATION DATA TO TRADING PARTNER?

As applicable

AUTHENTICATION

 
WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION?

The Central Drugs Standard Control Organisation (CDSCO)
MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY?

Yes (Exports)
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT?

No (Future)
DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT? No

GOVERNMENT REPORTING

 
MANUFACTURER ACTIVITY REPORTED? Yes
DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED?

No
Source and Credit: This information is fully or partly based on the GS1 master document (all rights reserved). As GS1 does not control the content of the information, GS1 shall not be held liable, under any circumstance, if it differs from the master document.

DISCLAIMER

This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just a possible interpretation of information available in the public domain and that interpretation is subject to change. This information does not constitute legal advice.

ABOUT KEVISION SYSTEMS

Kevision Systems, a part of the Kevin Group, is a leading solutions provider for complete end to end inspection of products & services for the inspection of pharmaceutical products like tablets, capsules and more. In addition to the inspection systems, Kevision’s Track & Trace Software & related equipment provide a fully integrated solution to the traceability of pharmaceutical products & Supply Chain Integrity.

Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.

Kevision Systems is dedicated and driven to provide the finest & the most optimum solutions for the Supply Chain Integrity as well as Optical Inspection Systems. We stand strong on the pillars of integrity, professionalism, innovation and expertise and have earned the credibility to work with any size of projects. We strive to excel in terms of quality and technology and be a preferred partner for our valued clientele.

For Further Information, please contact our Compliance Team at info@kevision.in

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