India deadline for drug export track and trace slips again

It’s all-change again in India’s verification system for pharmaceutical exports, with the government responding to widely-publicised issues with the portal used to upload data.

Earlier this year, the Ministry of Commerce and Industry confirmed that the Drug Authentication and Verification Application (DAVA) portal would be replaced with a new portal – called iVEDA (integrated Validation of Exports of Drugs from India and its Authentication) – that can be viewed here.

Criticism of the DAVA portal has been bubbling away for years, with drugmakers complaining of difficulties in complying with inflexible data uploading requirements, inadequate data security, delays at ports, and erroneous product recalls.

Specific problems have included problems uploading data in 2D barcodes in secondary and tertiary pharmaceutical packaging, and maintaining the parent-child relationship between these pack levels (aggregation data). Faced with a big overhaul of the system, the Ministry opted to scrap it and design a new portal from scratch.

Manufacturers had been required to start using the iVEDA portal from April 1, it official launch date, However, that deadline has now been extended to October 1, according to serialisation and traceability expert Dirk Rodgers on a recent webinar hosted by Systech.

The delay was announced in an update from the Ministry’s Directorate General of Foreign Trade (DGFT) dated March 31. It applies to all drugmakers, both large and small, says the notice. In the meantime, manufacturers are still required to print 2D barcodes on secondary and tertiary packaging.

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Local news reports suggest the delay has arisen in part by disruption caused by the coronavirus pandemic and the national lockdown.

Active pharmaceutical ingredient proposals

Rodgers also advised the pharma industry to keep tabs on draft proposals issued by India’s Ministry of Health and Family Welfare (MHFW) last year that would mandate QR codes with 11 pieces of data on all packaging levels of active pharmaceutical ingredients (APIs) if implemented.

The proposed data list is extensive, and includes for example the name and address of manufacturer, unique product identifier, name of the API, batch number and size, date of manufacture and expiry, serial shipping container code, and manufacturing or import license, plus any special storage conditions.

Much of that data “is more suited to databases than a barcode,” said Rodgers, who stressed the proposals are still only a draft and may well be modified after an ongoing comment period.