From: Life Sciences FICCI

Sent: 04 April 2022 21:30

To: mandeep@ias.nic.in
Cc: dci@nic.in; Swati Aggarwal <swati.aggarwal@ficci.com>; Life Sciences FICCI <lifesciences@ficci.com>
Subject: Introduction of Barcode/QR Code for top 300 pharma brands

Dr. Mandeep K. Bhandari

Joint Secretary
Ministry of Health & Family Welfare
Govt. of India

Subject - Introduction of Barcode/QR Code for top 300 pharma brands

Dear Sir,

This is in reference to Minutes of 87th DTAB Meeting held on 8th November 2021 wherein the
proposal for introduction of barcode/QR code for top 300 brands was discussed. We welcome
Government's efforts towards setting up a regulatory mechanism for introduction of trace and
track mechanism for the drug products sold in India.

It’s mentioned in the Minutes of the Meeting that some pharmaceutical companies have already
introduced bar coding system in some of the brands. On behalf of our members, we would like
to clarify here that the codes implemented by these companies are used only for commercial
purpose and include different data sets as against that required for authentication or
identification of pharmaceutical products.

As mentioned in the minutes of meeting, a roadmap has been prepared to identify the
technologies that can be used for barcode/QR code. We therefore request you to provide more
clarity on these technologies which are being evaluated as this will result in major change to
packaging lines, which requires significant time & cost to implement, and most manufacturers
must make these changes to multiple packaging lines.

We also understand that the Government is already aware on various parallel requirements
being mandated regarding the use of different technologies (QR codes for API’s, Barcodes on
Exported Products & QR code/Bar code for PPO) for achieving the same objective resulting in
complexity on ease of doing business in India.

The industry would like to understand which data set is to be included into barcode/QR code
and the manner in which the same would be required to be done to ensure that different
systems of different stakeholders are able to read and interpret the code. We would like to
inform you that a wrong interpretation of fields like the expiry date of the product lead to many
issues i.e. a date100322 may be interpretated in different formats by different service providers
i.e. MMDDYY, DDMMYY or YYMMDD.
It should be clear which key elements would need to be encoded into the barcode/QR code and
the manner i.e., format, field length, identifiers, in order to tell which data means what etc. The
clarity will also ensure interoperability, i.e., ability to scan the codes in different systems. With
today’s technologies it’s not needed to encode all data into the barcode/QR code as just a small
set of data like Product code, Batch and Expiry date can be displayed whereas all other
information could be extracted from the Central Database hosted by the Government
authorities (CDSCO/State FDAs).

We would suggest avoid using proprietary systems or standards developed by a particular vendor
and use only international standards so that the codes can be read by anyone who complies with
those standards and the available scanners/equipment in the market can be used.

We, therefore, request you to hold a stakeholders’ consultation at this stage i.e. before the
draft notification is released and to provide more clarity regarding the introduction of QR
code/Barcoding requirements for the top 300 pharmaceutical brands in the domestic market
so that stakeholders are aligned on this issue.

Thanking you

Kind regards,

CC: Dr. VG. Somani, Drug Controller General of India, CDSCO

Swati Aggarwal
Additional Director

Federation of Indian Chambers of Commerce and Industry

Industry's Voice for Policy Change
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