The date for implementation of track and trace system for export of drug formulations with respect to maintaining parent-child relationship in packaging levels and its uploading on Drug Authentication and Verification Application (DAVA) portal has been extended upto November 15, 2018 for both non-SSI manufactured drugs as well as SSI manufactured drugs.
A notification issued by the Directorate General of Foreign Trade (DGFT) on May 9, 2018 stated that export of drugs manufactured by SSI and non-SSI units and having manufacturing date on or before November 15, 2018 are exempted from maintenance of data in the parent-child relationship for three levels of packaging and its uploading on the central portal.
All drugs manufactured by SSI or non SSI units and having manufacturing date after November 15, 2018 can be exported only if both tertiary and secondary packaging carry barcoding as applicable and the relevant data as prescribed by DGFT is uploaded on the central portal.
For this, DGFT has amended Para 2.90A of Handbook of Procedure - 2015-20 (as notified vide Public Notice No.43/2015-20 dated 05.12.2017) read with Public Notice No. 52 / 2015-20 dated 05.01.2016, for laying down the procedure for implementation of the track and trace system for export consignments of drug formulations. The amended Para 2.90 A (vi) and (vii) which outlines the implementation date of track and trace system for export of drug formulations for non SSI as well as SSI units has been substituted and would read as above.
The DGFT notification has brought relief to pharmaceutical exporters who have been in the soup since last month following a notification by DGFT directing customs authority at Jawaharlal Nehru Port Trust (JNPT) not to allow export consignments failing to adhere to barcoding norms and data upload on DAVA portal.
A couple of weeks back, customs authority at Chhatrapati Shivaji International Airport, Mumbai also received the notification in this regard. It is learnt that 300-500 pharmaceutical containers were stuck at JNPT port following DGFT notification.
Meanwhile, pharmaceutical exporters have welcomed the DGFT notification. Says Nipun Jain, CEO, SME Panel, Pharmexcil who was instrumental in ensuring exemption from bar-coding for exports, “The DGFT notification has brought cheers to exporters. We appreciate the DGFT's efforts in addressing exporters' concerns and extending implementation of barcoding by six months giving them time to comply with it.”
Jain further said, “Glitches in functioning of DAVA portal has deterred exporters/manufacturers from uploading their products’ data on the portal for two level of packaging i.e. secondary and tertiary maintaining parent-child relationship. Now Union commerce ministry has directed National Informatics Centre (NIC) which developed the portal to upgrade it in six months to ensure its hassle free operation.”
The ministry also instructed DGFT to defer the implementation of bar-coding on pharmaceutical consignment for export to six months and start its execution in November when NIC resolves glitches of the central portal. It asked DGFT to issue a notification in this regard.
Echoing Jain's view Bhavin Mehta, director, Kilitch Drugs said, “The DGFT circular postponing implementation of barcoding by six months is a positive step in addressing problems faced by pharma exporters while adhering to track and trace norms. Now they have six months' time to get ready for the barcoding.”
We hope functioning of DAVA portal would get improved by then and exporters/manufacturers would be able to upload data on the portal smoothly, he added.