Date:

To,

Sub: Pharmexcil/CDAC proposal on track & trace and barcoding

Dear

On behalf of our members who are exporters of pharmaceutical drugs, we wish

to make the following submissions for your consideration and action to enable
the Indian pharmaceutical Industry to comply with both domestic and
international regulations on track & trace and barcoding, in a uniform and
affordable manner.

1. We understand that there is a move to redesign the existing DAVA portal and
modify DGFT notification on track & trace and barcoding, based on our recent
discussions with Pharmexcil and CDAC.

2. We are concerned that the proposal of Pharmexcil/CDAC would require our

member exporters to implement a parallel and additional system for track &
trace and barcoding which does not consider global standards for
identification and traceability and which is not in line with existing global
practices and regulations. This would isolate India from the rest of the world,
while imposing huge additional costs and efforts on each member exporter,
without any commensurate benefit beyond what is already available through
the DAVA portal.

3. We wish to point out that several international regulations and guidelines, in

particular those issued by US FDA, EU Commission (EU Falsified Medicines
Directive implemented since Feb.19), England NHS, USAID, UNFPA, Global
Fund, GAVI the Vaccine Alliance, UNICEF, and others specifically require
interoperability at a global level in supply chains for exchanging information
to enable global track & trace based on global standards and therefore
avoidance of parallel and competing structures. In September 2019, 25
African countries and 6 international organisations signed the “Africa Strategy
for Pharmaceutical supply chain traceability” confirming the commitment of
the signatories to fight against falsified medicines using global standards.
 Consequently, stepping away from this harmonised approach would not
benefit markets and companies receiving these products either, as most
countries applying traceability requirements today use global standards.

4. Over the past years, each member exporter has already invested very
substantive costs & efforts in compliance with the DGFT notification of 2011
and over 500 pharma companies had been successfully uploading daily
production data into the DAVA portal as per DGFT’s requirements.

5. There were some issues faced related to performance of the DAVA portal, like
e.g. aggregation etc, which can be sorted out without having to reinvent a
new system altogether which is different from global practices/
implementations on track & trace and barcoding which requires using GS1
global identification standards.

6. Despite the DAVA portal not being optimally functional, 120 pharma
exporters have still voluntarily uploaded 5,816 product files, 10,504 batch
files and 74,654 tertiary files into DAVA portal between April and November
19. They are doing so as they have already implemented DGFT requirements
for drugs for export as a part of their standard operating procedures and as
part of compliance with prevalent and emerging global regulations. A
substantial change instead of resolving the identified issues would create
significant burden to the industry. More importantly, it could undermine
efficient and successful implementation as well as the interoperability of the
track and trace system.

In light of the above, we strongly urge your reconsideration and request a

meeting at an early date to enable us apprise you of the ramifications and
negative implications of the proposal.

Please advise on a mutually convenient date for the above.

With kind regards,