India to make medicines export database public?

Data generated in India's barcoding initiative for exported drugs will be made publicly available, in a bid to restore the reputation of the country's pharma sector, according to local press reports.

An article in the Economic Times newspaper suggests that regulators in other countries and other stakeholders will be able to access the central database to which pharma exporters will have to upload barcoding data.

Citing an unidentified official in the Indian government, the report says that the pilot phase for uploading data will start later this month, with drugmakers such as Sun Pharma, Wockhardt and UniChem among those road-testing the system.

Pharmexcil - a body which represents Indian pharmaceutical exporters - is hosting a half-day seminar on Friday to discuss the coding requirements and introduce the central portal or Drug Authentication and Verification Application (DAVA), which has been developed by India's National Informatics Centre (NIC).

Barcoding on secondary and tertiary packing has been made mandatory by India's Directorate General for Foreign Trade (DGFT) for all pharmaceutical products, but coding for primary packing was recently exempted until further notice. The requirement to code is also exempted in cases where the drug in question is being exported to a market with comparable coding requirements.

India exported $15bn-worth of pharmaceuticals in 2013-2014, a 2.5 per cent increase on the prior year, according to Pharmexcil's latest annual report.

Last year, the country's Central Drugs Standards Control Organisation (CDSCO) started offering cash rewards to informers who help bring criminals selling spurious Indian-made drugs, devices and cosmetics to justice.

The CDSCO reported a sampling study last year that found nearly 10% of drugs made in Jammu and Kashmir were substandard but identified no spurious of falsified medicines.

An earlier nationwide survey - reported in 2009 - put the proportion of spurious medicines as low as 0.05 per cent, although there have been allegations of sampling bias in this study.