As part of its efforts to further streamline the procurement and tracking of drugs, Union health ministry has made barcodes using GS1 identification standards compulsory for all drugs, medical devices and other medical supplies purchased by the government. The mandatory use of GS1 barcodes will be implemented in two phases, with the first phase starting from October 1, 2011 and the second phase starting from April 1, 2012.
The primary objectives of barcode implementation are to enable efficient management and monitoring of stock levels of all medical supplies including drugs, medical devices etc procured under various programmes and schemes and also to enable track and trace of all medical supplies to facilitate detection of spurious/counterfeit products and product authentication.
In the first phase of implementation beginning from October 1, 2011, all suppliers of drugs have to incorporate barcode using GS1 standards at various packaging levels, encoding: product identification code (GTIN—global trade identification number) at primary level packaging; product identification code (GTIN), expiry date and batch no at secondary level packaging; and product identification code (GTIN), expiry date and batch no and SSCC (Serial Shipping Container Code) at tertiary level packaging.
For primary packaging of small pharma products where due to space constraints barcoding may not be possible, these information should be printed in human readable form using GS1 standards.
In fact, the ministry had proposed to implement barcoding from April 1, 2010. But, the ministry decided to postpone the implementation as it received representations from the industry asking the government to consider differentiating between medical devices and drugs from the implementation time line.
The ministry held several rounds of meetings with the industry representatives and finally it was decided at the meeting held on March 16 this year to adopt a phase-wise approach to facilitate compliance by the industry.
The implementation of GS1 barcodes for medical devices has been deferred till April 1, 2012.