Ref: PXL/H.O./CIR-020/2015-16 Date: 24.05.2015
All the Members of Council,
Subject: "Procedure for Implementation of Track & Trace System for export of Drug Formulations"-DGFT Public Notice dt: 22nd May 2015.
Members are kindly aware, based on the feedback/inputs received from our member companies, Pharmexcil made several representations to Commerce Ministry for making amendments in the DGFT notification of 1st April 2015. With kind support of Department of Commerce, Pharmexcil has also organized a hearing with industry. After considering our submissions sympathetically, Government / DGFT has issued a revised notification where in most of the submissions made by industry / associations / pharmexcil have been favorably considered. The details major changes in the requirements are given below:
1. Primary pack: 14 digit human readable GTIN on optional basis only.
2. Secondary pack: need for affixing bar code on mono cartons with one primary pack , on optional basis only.
3. Parent - Child relationship between Primary and Secondary packs:
The need for maintenance of parent-child relationship between primary and secondary packaging is on optional basis only.
4. Data loading on central server:
The need for uploading data on central server to be maintained by Government has been revised from 1.4.2015 (effective 1.7.2015 ) to 01.10.2015.
We are thankful to Department of Commerce, especially Shri Sudhanshu Pandey, Joint Secretary, Sri Rajeev Kher, IAS, Secretary, Smt. Nirmala Seetharaman, Honorable Minister for their very kind understanding of the issues / problems of industry and their commitment to promote pharma exports in a sustainable manner.
A copy of the DGFT Notification on the Procedure for Implementation of the Track and Trace system for export of drug formulations is enclosed(click here) for your kind information.
Madan Mohan Reddy
Dr. P V Appaji