QR Code (Quick Response Code) on import of APIs

[MANOHARAN ARUMUGAM]

GOI has issued a Notification duly amending Rule 96 of Drug Rules 1945 which reads as below;

“(5) Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing.'

As per the insertion effective from 1st January 2023 no import of APIs without QR code is possible. Foreign suppliers are apprehensive that within short span of time, they cannot comply with the regulations.

My question is what will happen for the shipments in transit which may land India on or after 1st Jan.2023. I pesume that if the On-Board AWB or Bill of Lading is issued prior to 1st January 2023 it can be cleared. Anybody clear my doubts or any relaxation in implementation is proposed.

A.Manoharan

[Shraddha N]

Hello,

This is great step which the Indian government is taking which will end the counterfeiting of drugs and also helps in Bulk Drug Traceability in the supply chain.

India is the first one in world to mandate serialization on API (Bulk Drug).

And many companies has started their pilot projects and successfully implemented QR code serialization on Bulk Drug and it is not that costly if one already have existing setup and it is just online software to create complied QR codes and same can be printed using any basic printer. and such softwares can also have configurations to add your existing label details on their label with QR Code. If you want to know more you can contact one such system supplier named URL Aseptic Automation Inc-which is into pharma machinery-pharma softwares (track & Trace - aggerecation-serialization) 21 CFR complied machnes and softwares, Pharma Automation. To know more about their cloud base QR Code solution for API, you can further contact on: 7573035323 or can mail on [email protected] .

AI Summary

Quick Response code requirement on APIs: imports without compliant QR codes will be prohibited after implementation, raising transit compliance concerns. The amendment to Rule 96 mandates that every active pharmaceutical ingredient (API) manufactured or imported must bear a Quick Response code on its label at each level of packaging to enable machine-readable tracking and tracing, and indicates that imports of APIs without such QR codes will not be permitted after implementation; the text queries whether shipments in transit with on-board transport documents issued before implementation will be allowed clearance.