Ref: PXL/H.O./CIR-111/2015-16                                  Date: 14.01.2016

Hyderabad

Dear Sir / Madam

We wish to inform that based on representations from Industry, Council took up with Department of Commerce for giving some more time for exporters, particularly small exporters, for implementation of barcoding. We are pleased to inform that Government issued a Notification on 5th January 2016 extending the time for implementation of  additional requirements  for barcoding for SSI  and non SSI manufactures with different dates.  Members may click hereto see the Notification issued by DGFT.

For the benefit of members, we would like to highlight the effects of above Notification as follows:

a)   All  Non-SSI  manufacturers  are exempted from maintenance of Parent-Child relationship (between secondary and tertiary pickings) and its uploading on DAVA portal till 31.3.2016

b)   All SSI manufacturers are exempted from maintenance of Parent-Child relationship (between secondary and tertiary packaging)  and its uploading on DAVA portal till 31.3.2017

c)   All manufacturers (both SSI and non-SSI) are required to continue upload the other required data  on DAVA portal, as per DGFT notification dated 22.5.2015, which is effective from 1.10.2015

d)   Barcoding is required for only those drug formulations which are manufactured under Drug Manufacturing License issued as per Drugs & Cosmetics Act & Rules thereunder and registered as ‘Drug’ by FDA of importing country.  This means,   products like nutraceuticals etc., which are not registered as ‘Drug’ by the importing countries are exempt from barcoding.

e)   Guidelines for availing any exemptions, data maintenance / uploading in the Dava portal etc., will be made available under DAVA portal (www.dava.gov.in).

We request the members to go through the notification thoroughly and inform us if any clarifications have to be sought from Government. Regularly updated clarifications will be made available on DAVA portal / Websites of Pharmexcil and GS1.

With regards,

Dr. P V Appaji