| REGULATORY AGENCY | India Ministry of Commerce and Industry, Department of Commerce, Directorate General of Foreign Trade (DGFT) |
| REGULATION NAME | Pharmaceuticals and Drug Consignments |
| COMPLIANCE DATES | (DGFT), under the ministry of commerce and industry, has announced the withdrawal of mandated Track and Trace system for export consignments of drug formulations. The implementation of the authentication system for drug formulation being exported shall be undertaken by Ministry of Health and Family Welfare in line with the provisions under drug rules 1945 (i.e. Rules for 300 drug brands) |
| APPLIES TO | Drug manufacturers who export drugs to any other countries. |
(A carton containing one or more primary packs and includes a “mono carton” containing one primary pack)
| BARCODE SYMBOLOGY | Previously : Linear, or 2D Datamatrix following GS1 standards (as per latest update, regulation has been withdrawn) |
| BARCODE CONTENTS |
|
| SERIAL NUMBER RANDOMIZATION | No |
| SERIAL NUMBER REUSE | Not Specified |
| HUMAN READABLE EXPIRY DATE FORMAT | YYMMDD |
| BARCODE DATA ENCODING | Earlier GS1 Standards (as per latest update, regulation has been withdrawn) |
| 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 |
(A shipper containing one or more secondary packs)
| BARCODE SYMBOLOGY | Earlier GS1-128 linear (as per latest update, regulation has been withdrawn) |  | |
| BARCODE CONTENTS | Product code (use of the GS1 GTIN is now optional), Lot Number,Expiration Date, GS1 SSCC (SSCC may appear in a separate barcode) | ||
PARENT-CHILD MAPPING AGGREGATION CAPTURE? | Not Required |
| SEND UNIT DATA TO GOVERNMENT REPOSITORY? | No (as per latest update, regulation has been withdrawn) |
| SEND UNIT DATA TO THIRD-PARTY REPOSITORY? | As applicable |
| SEND UNIT DATA TO TRADING PARTNER? | As applicable |
| SEND AGGREGATION DATA TO GOVERNMENT REPOSITORY? | No (as per latest update, regulation has been withdrawn) |
| SEND AGGREGATION DATA TO THIRD-PARTY REPOSITORY? | As applicable |
| SEND AGGREGATION DATA TO TRADING PARTNER? | As applicable |
| WHO OFFERS DATA REPOSITORY FOR AUTHENTICATION? | No (as per latest update, regulation has been withdrawn) |
| MANUFACTURERS MUST REGISTER SHIPMENTS IN REPOSITORY? | No (as per latest update, regulation has been withdrawn) |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON RECEIPT? | No (Future) |
| DOWNSTREAM TRADING PARTNERS MUST AUTHENTICATE ON SHIPMENT? | No |
| MANUFACTURER ACTIVITY REPORTED? | No (as per latest update, regulation has been withdrawn) |
| DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED? | No |
| 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 |
(Packaging which is in direct physical contact with the active ingredient)
| BARCODE SYMBOLOGY | As per the GS1 standards |
| BARCODE CONTENTS |
|
| 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 |
| FREE SAMPLES MUST BE MARKED? | Not Specified |
(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 |
|
| 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 |
(A shipper containing one or more secondary packs)
| BARCODE SYMBOLOGY | As per GS1 standard | | |
| BARCODE CONTENTS | GS1-128 (SSCC)
| ||
PARENT-CHILD MAPPING AGGREGATION CAPTURE? | Not Specified |
| 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 |
| 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 |
| MANUFACTURER ACTIVITY REPORTED? | Yes |
| DOWNSTREAM TRADING PARTNER ACTIVITY REPORTED? | No |
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Built on the cornerstone of strong quality focus, we deliver excellent solutions with very high quality & reliability.
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For Further Information, please contact our Compliance Team at info@kevision.in
