DGFT Update: iVEDA will be the New Web Portal for Validation and Authentication of Drugs Export from India

The Directorate General of Foreign Trade (DGFT) has extended the date of implementation of track and trace system for drug formulations with respect to maintaining the parent-child relationship in packaging levels and its uploading on central portal till October 1, 2020 for both SSI and non-SSI manufactured drugs.

The Union commerce ministry, through the Centre for Development of Advanced Computing (C-DAC), was supposed to launch the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal for drug authentication and tracking and tracing of the drug supply from April 1, 2020.

The DGFT has taken the decision to defer the implementation of track and trace system for drugs meant for export by six months in view of the coronavirus outbreak and lockdown announced by the government to contain its spread.

As per the new directive, Pharmaceutical exporters in India will now have to implement the Track and Trace system. The Central system will be changed from DAVA to iVEDA (Integrated validation of exports of drugs from India and its authentication) portal from 01.10.2020.

The iVEDA portal is envisaged to help manufacturers and merchant traders to generate and utilise tertiary and secondary level coded data in a user-friendly manner. The manufacturers and exporters are required to upload data on barcode on secondary and tertiary packaging of drugs meant for export on the portal. According to Public Notice No. 52/2015-2020 dated the 05 January 2016 specified specific dates of implementation of the parent-child relationship for all manufacturers/exporters as below:

A one-time exception was granted to all manufacturers/exporters, that they were exempted from maintenance of parent-child relationship in packaging and its uploading on the central portal (https://dava.gov.in) till 31.03.2016.

After 31.03.2016, the exemption was removed and all maintenance of the parent-child relationship in packaging and its uploading on the central portal (https://dava.gov.in) became mandatory.

The manufacturer uploading data on the central portal must have manufacturer code and product code allotted by GS1 India. The manufacturer can get C-DAC codes in case it has not yet subscribed to get codes from GS1 or any other agencies. The manufacturer must have Digital Signature Certificate of Class-II or Class-III issued by any Certifying Authority (CA) in India.

The DGFT barcoding requirement initially talked about putting a 2D Data matrix encoded with the required information and in human-readable form on the Secondary packaging level (including mono cartons) and a 1D linear barcode on the Tertiary packaging level.

The responsibility of the correctness, completeness and ensuring timely upload of data on the central portal shall be with the manufacturer. However, the manufacturer may extend the responsibility to anyone next to it in its supply chain i.e. wholesalers/distributors/retailers etc. in its supply chain.

To register in the central portal (IVEDA), Manufacturers and Merchant exporters need to visit the IVEDA website (click here to visit iVEDA) and register. Once registration and verification are done, approval will be done by Pharmexcil (Pharmaceutical Export Promotion Council of India) and then user can see the dashboard. Every company will have a profile in the iVEDA portal. The iVEDA has provision to upload product and production data.

The new update also states different requirements for GS1 and non-GS1 pharmaceutical manufacturers and exporters.

Another addition to the update was that Veterinary products will also be now included under DGFT barcoding requirements.

The test run workshop on iVEDA portal was held by Pharmexcil at 4 places in India i.e Mumbai and Ahmedabad on February 10 & February 11 and in Hyderabad and Chandigarh on March 3 & March 5. The workshop was attended by manufacturer-exporters, merchant exporters, contract manufacturer exporters, etc. The objective of the workshop was to provide industry hands-on experience and get their feedback to make the portal more robust and industry friendly.

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Source :

• https://pharmexcil.com/circulars.html
• https://www.pharmasecure.com/iveda/
• https://www.pharmabiz.com/NewsDetails.aspx?aid=122238&sid=1

Data assembled and proposed by : Awnish Singh, Consultant at tracekey solutions GmbH ((B.Sc. (Biotechnology), MBA (Finance & Marketing)).