Some Indian drugmakers still aren’t coding exported drugs

A major investigation into the Indian pharma industry’s compliance with traceability requirements for exported drugs has resulted in goods worth around $150m being detained.

The large-scale sampling action by customs officials at Jawaharlal Nehru Port Trust (JNPT) – the port authority of Mumbai – was intended to check whether the exported medicines were compliant with the track-and-trace regulation of India’s Directorate General of Foreign Trade (DGFT), which was introduced in 2016 to bolster the reputation of India’s pharma industry amid claims that it was a source of falsified medicines.

While initial press reports suggested that the non-compliant consignments were from small pharma manufacturers, a senior figure in the Indian pharma industry close to the matter tells that some shipment sold by major Indian manufacturers and multinational companies (MNCs) were also found to be non-compliant.

According to the source, customs officials undertook a sampling operation to ensure that shipping cases, and in some instances the inner cartons, were properly barcoded and that they could be authenticated via India's Drug Authentication and Verification Application (DAVA) portal.

Almost 500 containers from companies both large and small were examined during the operation between April 13 and May 3 – which also included some medicine shipments destined for humanitarian aid distribution – and found multiple cases in which barcoding was not present or properly displayed on secondary and tertiary packaging.

All the offending shipments have been barred from export, while some have been sent back to the manufacturer and others have been detained at the port until corrective action could be take; it is not clear what the status of those shipments currently are.

We asked Systech International’s senior global partner Avi Chaudhuri to comment on the current situation, who said: “This reported action by Indian Customs officials illustrates the critical importance of properly complying with current and emerging serialization, traceability, and reporting regulations.

“It is widely expected that the situation will only get worse in coming months with the advent of US and EU regulations. The problem will be transformed from getting products out of India into getting them through the ports of regulated countries and into a highly regulated supply chain with demanding requirements.”

Parent-child packaging data

With companies still failing to meet the preliminary barcoding requirements it will come as no surprise that the DGFT has set back its implementation deadline for aggregation data for shipments – i.e. recording the parent-child relationship in packaging levels and uploading the data to the DAVA – to November 15, 2018.

A DGFT notice published on May 9 notes that both small (SSI) companies and non-SSI manufacturers will only have to start uploading the data for drugs produced after that date and – in theory at least – shipments without that information will not be exportable.

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