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

AI Summary

Indian Government Amends Rule 96 of Drug Rules 1945, Mandates QR Codes on APIs to Combat Counterfeiting A discussion on a forum addresses the Indian government's amendment to Rule 96 of the Drug Rules 1945, requiring QR codes on all active pharmaceutical ingredients (APIs) imported or manufactured in India from January 1, 2023. Concerns are raised about compliance difficulties for foreign suppliers and the status of shipments in transit. A response highlights the benefits of this regulation in combating drug counterfeiting and enhancing supply chain traceability. It notes India's pioneering role in mandating API serialization and mentions that implementing QR code systems is feasible and not costly for companies with existing setups.