India baulks at barcoding domestic drugs; report

India’s slow progress towards implementing a coding system for medicines circulating within its borders has moved on a step, according to local news reports.

A proposed system for adding unique alphanumeric codes – rather than 2D barcodes – to the packaging of medicines that can be used for verification purposes has been put forward by the Drug Controller General of India (DCGI) and approved by the Drugs Technical Advisory Board (DTAB), according to a Pharmabiz report.

India operates a barcoding system for exported pharmaceuticals – although recent reports suggest that compliance with it is far from optimal – and for years has been negotiating a way to extend the system to medicines distributed and sold domestically.

A perennial stumbling block has been the impact of such a system on small and medium sized enterprises (SMEs), known as small-scale industry or SSI companies in India, and the risk that compliance could disrupt their operations and the supply of medicines.

Recognising that, the DCGI’s proposal is for a step-wise introduction of the system starting with 300 brands that will carry the unique code plus a contact telephone number.

By texting the code to the number they will receive a response indicating whether the code is genuine, and detailing the drug manufacturers’ name, batch number, manufacturing date, and the expiry date of the medicine. It’s a method that has been adopted in a number of countries around the world, particularly in Africa, but falls short of the rigour of a full track-and-trace or end-to-end verification system.

The 300 or so brands account for 90 per cent of counterfeiting activity in India, according to the Pharmabiz report, which cites DCGI Dr S Eswara Reddy as saying that alphanumeric codes will suffice to tackle the problem as barcoding would be too costly and “it is not required to introduce track and trace system for all drug manufacturers.”

In 2015, India’s government published a proposal that called for track-and-trace for all pharmaceutical drugs produced for domestic use, based on serialization to provide a unique ID for medicine packs, barcoding at the primary, secondary and tertiary pack levels and reporting – including aggregation – via the Drug Authentication and Verification Application (DAVA) portal used for exported medicines.

SecuringIndustry.com is trying to find out more about the proposals approved by the DTAB and will update readers in due course. Have an opinion on this development? Don't hesitate to reach out to us at newsdesk@securingindustry.com.