Authority: Ministry of Health and Family Welfare of India

Request Source: Indian Ministry of Health and Family Welfare Tender Conditions

Data Carrier: GS1-128 / GS1 Data Matrix

Details: Although the compliance deadline for drug traceability in India was announced as 1 April 2020, it was later updated to 1 October 2020. According to the decisions of the Ministry of Health and Family Welfare of India, pharmaceutical products should be serialized according to GS1 standards, and all drug boxes that will be transported should be marked with SSCC. The Ministry has a digital portal developed for suppliers to upload their information regarding SSCCs. According to the official gazette published on January 18, 2022, pharmaceutical manufacturers and importers must comply with the traceability requirements as of January 2023. The implementation date of the traceability system for the export of pharmaceutical formulations for maintaining the parent-child relationship at the packaging level and the date of uploading the data to the Central Portal have been updated to be March 31, 2023. According to the latest information, on June 14, 2022, the Indian Ministry of Health issued draft rules on barcodes and QR codes for 300 brands. According to the information contained in the draft, the serialization implementation will begin on May 1, 2023.

16 Digit Secondary Pack Coding

• Pack Level (1)
• Packager Code (3)
• Pack Type (1)
• Serial Number (10)
• Check Digit (1)

14 Digit Shipper Code

• Pack Level (1)
• Packager Code (3)
• Pack Type (1)
• Serial Number (8)
• Check Digit (1)

Coding Requirements for APIs:

Unique product identification code
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 license no. or import license no.
Special storage conditions required (if any)

Links:

https://www.mohfw.gov.in/
https://main.mohfw.gov.in/
https://cdsco.gov.in/opencms/opencms/system/modules
https://content.dgft.gov.in/Website/dgftprod
https://cdsco.gov.in/opencms/opencms/system/