After years of dilly-dallying and several rounds of postponement due to stiff resistance from the industry, the Union Commerce Ministry has announced the implementation of track and trace system for export of pharmaceuticals and drug consignments on secondary level packaging including mono cartons, which is being introduced by the government to check the spread of spurious and fake drugs in the international market.

The Commerce Ministry had initiated the steps in this direction as early as in 2010 to put in place some system after repeated stories in the foreign media continued to malign the image of the domestic pharmaceutical industry. Reports, allegedly backed up by the multinationals, sought to project India as a hub of spurious medicines, notwithstanding the official clarifications and tests that confirmed only a minuscule quantity of drugs in India was spurious or substandard.

As per the Ministry's initial plan, the trace and track system for pharmaceutical export was to come into effect in the country from July 1, 2011. But the Ministry revised the implementation at the eleventh hour as per that the system was to be enforced in phased manner from October 1, 2011. The trace and track technology was to be made compulsory for tertiary level packaging with effect from October 1, 2011 and that on secondary level packaging was to become effective from January 1, 2012. Likewise, the new technology was to be made mandatory on primary level packaging only from July 1, 2012.

Earlier in June 2013, the commerce ministry had deferred the implementation of barcoding on export consignment of pharmaceuticals and drugs on primary level packaging till further notification from the ministry. The requirement of affixing barcodes on primary level packaging was to be effective from July1, 2014. Now this date has been deferred till a new date is notified by the ministry.

But, due to stiff resistance from the industry, the Ministry was forced to postpone repeatedly the implementation of bar-coding on secondary level packaging. The bar-coding on tertiary level packaging has already come into effect in the country from October 1, 2011.

The industry was especially peeved at the Commerce Ministry's recent action in which the ministry had notified that the mono cartons will be treated as secondary level packaging. Earlier through Public Notice No. 31 dated October 17, 2013, mono cartons were to be treated as part of primary level packaging. Now this has been modified to treat mono cartons as secondary level packaging, the DGFT in its notification dated June 26, 2014 had said.

According to a recent notification, the track and trace system for export of pharmaceuticals and drug consignments on secondary level packaging including mono cartons has come into effect in the country from April 1, 2015.

In the notification, the Directorate General of Foreign Trade (DGFT) has said that the ministry has inserted Para 2.89 A in Handbook of Procedure, 2015-2020, under which the manufacturer of drug for formulations will print the barcode as per GS1 Global Standard at different packaging levels to facilitate tracking and tracing of their products.

As per the notification, on the Primary Level packaging, the ministry has mandated incorporation of two dimensional (2D) barcode encoding unique and universal global product identification code in the format of 14 digits Global Trade Item Number (GTIN) along with batch number, expiry date and a unique serial number of the primary pack.

The bar code labelling at primary level is exempted till further notification, however the above mentioned details are required to be printed in human readable form.

On Secondary Level packaging, the ministry has mandated incorporation of one or two dimensional (1D or 2D) barcode encoding unique and universal global product identification code in the format of 14 digits GTIN along with batch number, expiry date and a unique serial number of the secondary pack.

On Tertiary Level, the ministry has mandated incorporation of one dimensional (1D) barcode encoding unique and universal global product identification code in the format of 14 digits GTIN along with batch number, expiry date and a unique serial number [Serial Shipping Container Code (SSCC)] of the tertiary pack.

The manufacturer shall maintain the data in the parent-child relationship for all three level of packaging i.e. Primary, Secondary and Tertiary and their movement in its supply chain. The data mentioned above, shall be uploaded on the central portal of the Government of India by the manufacturer or its designated agency before release of the drugs for sale or distribution. The responsibility of the correctness, completeness and ensuring timely upload of data on the central portal shall be with the manufacturer, the notification said.

The above rules will not be applicable to those drug formulation manufactured for export purposes, where the government of the importing country has mandated a specific requirement and the exporter intends to avail the option of printing the barcodes in their format with the permission of licensing authority appointed under Rule 21.

However, the tertiary level of packaging will have additional printing of barcode as per (i)(c) above in addition to importing country’s requirement, if any.

The exports of the drugs having manufacturing date prior to April 1, 2015 will be exempted for requirement of barcode labelling and data uploading on central portal. The drugs with manufacturing date on or after April 1, 2015 will compulsorily carry barcode on tertiary and secondary packages as per the Notification No. 68 dated August 6, 2014.

However the requirement of data uploading on central portal will be exempted till June 30, 2015. With effect from July 1, 2015, all drugs with manufacturing date on or after April1, 2015 can be exported only if both the tertiary and secondary packaging carry barcoding as applicable and the relevant data as prescribed by DGFT is uploaded on the central portal.

In the notification, the Commerce Ministry has explained that primary packaging means the package which is in direct physical contact with the drug, secondary packaging means the carton containing multiple primary packs including a mono carton and tertiary packaging means a shipper containing multiple secondary packs.

Meanwhile, there were protests from the industry against the implementation of barcode, especially on mono-cartons on export consignment of pharmaceuticals and the exporters in the country have been demanding to the ministry to exempt barcodes on mono cartons as a secondary level packaging on export consignment of pharmaceuticals and drugs as the pharma exporters, especially the SMEs, are struggling to come to complete terms in complying with barcoding on tertiary and secondary packs.

In a representation to the ministry, Indian Drug Manufacturers Association (IDMA) president S V Veerramani explained that each mono cartons contains just one strip of the medication, the size of the mono cartons for the blister packings and the ampoules is too small to accommodate the barcoding. These mono cartons are then packed in another outer cartons which has the barcoding. Since the pack in which the mono cartons are packed has the barcoding for the purpose of trace and tracking, so the barcoding on mono cartons should be exempted and maintained only on the immediate outer pack of the mono cartons.