Deadline to affix barcodes on drugs extended till July 2012 -Governance Now

Deadline to affix barcodes on drugs extended till July 2012

Pharma industry had sought more time for implementation

PTI | July 1, 2011

The Commerce Ministry on Thursday extended the deadline for mandatory barcoding of pharma products meant for overseas markets till July 2012, a move which will provide relief to drug exporters.

Earlier this year, the Directorate General of Foreign Trade (DGFT) had said that from July 1, 2011, medicines exported from India would be required to have barcodes.

A barcode is an optical machine-readable representation of data on the product it is attached to and facilitates its tracing and tracking.

"Earlier the requirement of affixing barcodes was to come into effect from 1.7.2011. Now more time is being allowed," DGFT said.

The Indian pharmaceutical industry had sought more time to implement the process required for mandatory barcoding.

DGFT said the deadline for barcoding on primary packaging -- the material that first envelops the product and is in direct contact with the contents such as ampoule, vial, bottle, cartridge, blisters -- is extended till July 1, 2012.

For secondary packaging -- intermediate medical packing) -- it has been extended till January 1, 2012 and for tertiary packaging -- used for bulk handling, warehouse storage and transport shipping such as cartons -- the deadline is October 1, 2011.

DGFT said exporters will need to affix barcodes entailing unique product identification code, unique serial number of the respective packs, batch number and expiry number.

"Under the track and trace system, manufacturers would be required to maintain serialised record of exported pharmaceutical products for a minimum period of six months after the expiry date of the product," it added.

It also said the Government will set up a Central Portal for tracing and tracking exported pharma products.

According to experts, the move is not only aimed at improving reputation of the Indian pharma industry in the international market but it also aims at curbing illegal channels of trade. For instance, spurious drugs found in Nigeria in 2009 were labelled 'Made in India' but were finally traced to China.

Pharmaceutical companies and exporters had raised concerns that affixing barcode is expensive and it cannot resolve the problem of spurious drugs.

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