DGFT defers track and trace deadline for pharma exports to October 1, 2020

MSMEs, SSIs continue to find it difficult to maintain a 'parent-child' relationship at the packaging level and uploading on central portal

By Usha Sharma On Mar 31, 2020

The Directorate General of Foreign Trade (DGFT), an arm of the Ministry of Commerce and Industry, Government of India extended the deadline for implementation of the track and trace system for export of drug formulations with respect to maintaining the ‘Parent-Child’ relationship at packaging levels and its uploading on the central portal up to October 1, 2020 for both SSI and non-SSI manufactured drugs.

A system was introduced by the DGFT for barcoding of pharmaceutical products exported from India. The requirement was for barcoding of secondary and tertiary packaging with UID and 14 digits GTIN along with the batch number, expiry date etc. Subsequently, the requirement of maintaining ‘parent-child’ relationship was introduced.

Under this system, exporters are required to upload the data on a portal named DAVA managed by National Informatics Centre (NIC).

The portal has had serious glitches since its inception resulting in hardship to exporters such as inability to upload data and difficulty at the port level for verification of data uploaded by exporters.

This results in export consignments being rejected at the customs level resulting in undue hardship to the industry particularly MSMEs.

BR Sikri, Chairman, FOPE expressed, “Based on the representations from the industry, the original notification, which was issued in 2016 has been revised and extended numerous times, the last deferment being on March 30, 2020 and fixing a new date of implementation of October 1, 2020. The industry feels that the requirement of maintaining a ‘parent-child’ relationship is difficult to be implemented in the absence of proper infrastructure at DAVA and if implemented, pharma exports from the country may suffer. Further barcoding shall be as per the requirement of the importing country where in many countries the system of tracing or authentication of imported consignments is not in place.”

Dr PV Appaji, Founder Executive Director and retired Director General, Pharmexcil said, “The government’s intention is very good, but it looks like some factors have not been taken into consideration like technical complications, low capacities and very high costs involved in the implementation particularly to MSMEs./ SSIs . He continued explaining, “During my tenure in Pharmexcil as DG, I had raised the concerns on behalf of MSMEs. However, the government’s objective, behind implementing this scheme in toto is to protect India Pharma brand image in overseas markets . However, it may take further more time than its extended timeline (October 1, 2020).

Dr Appaji also suggested that MSMEs could be excluded from the requirement of compulsory parent-child track and trace packaging. His reasoning was that almost 80 per cent of formulations export is done by larger companies who would not find it difficult to meet this requirement.

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