India Reschedules Drug Export Track And Trace Plan
This article was originally published in SRA
India has deferred the implementation of its track and trace system for pharmaceutical exports - measures that are essentially aimed at curbing the menace of fake products and also enhance supply-chain safety1.
India's Directorate General of Foreign Trade said that the dates for implementation of the track and trace system for exports of drug formulations along with maintaining the "parent-child relationship" in packaging was being "extended" to April 1, 2016, for non-SSI [small scale industries] manufactured drugs and to April 1, 2017, for SSI-made ones.
"All drugs manufactured by non SSI units with manufacturing date on or after April 1, 2016, and all drugs manufactured by SSI units with manufacturing date on or after April 1, 2017, can be exported only if both the tertiary and secondary packaging carry barcoding as applicable and the relevant data as prescribed by the DGFT is uploaded on the central portal," a government notice dated Jan. 5, said.
In May last year, India specified that effective October 2015, all drugs with a manufacturing date on or after Oct. 1, 2015 would be permitted for export only if the barcoding and data uploading requirements were met.
The latest notice, however, specifies that drug exports with a manufacturing date prior to March 2016 (in the case of non-SSI units) and prior to March 2017 (for SSI units) are exempt from the "requirement of data uploading" on the central portal.
A one-time exemption for all manufactures from maintenance of parent-child relationship in packaging and its uploading on the central portal till March 31, 2016, has also been specified. However, printing of barcoding on the different levels of packaging will be applicable.
The bulk of Indian pharma exports are from large firms.
Small and medium-sized firms have been pressing for more time for the implementation of the bar coding requirements, citing the huge investments required for machinery and the limited availability of skilled personnel in the area.
Large firms, though, have in general welcomed the government's rules, hoping that it will help check baseless allegations against Indian generic exports as seen in the past when counterfeits made elsewhere were falsely touted as being of Indian origin.
Some years ago, Nigeria's National Agency for Food and Drug Administration and Control had detained a large consignment of counterfeit generic antimalarials labelled "Made in India" but produced in China.
Barcoding
Indian formulation manufacturers or exporters are expected to print barcodes as per GS1 Global Standard at different packaging levels to facilitate the track and trace system.
At the tertiary level, India had earlier mandated the incorporation of a one dimensional (1D) barcode encoding unique and universal global product identification code in the format of 14 digits Global Trade Item Number (GTIN) along with the batch number, expiry date and a unique serial number [Serial Shipping Container Code]2.
At the secondary level, India similarly requires the incorporation of one or two dimensional (1D or 2D) barcode. Exporters, though, can affix bar codes on mono cartons containing one primary pack on an optional basis, till further notification, the latest notice said. The Indian Drugs Manufacturers' Association had earlier urged the government to restrict the requirement of barcoding only to the outer package for mono cartons.
At the primary packaging level, India has ordered the incorporation of a two dimensional (2D) barcode encoding unique and universal global product identification code in the format of 14 digits GTIN along with the batch number, expiry date and a unique serial number of the primary pack.
Bar code labeling at the primary level is, however, "exempted" till further notification, though the details specified therein are to be printed in readable form on an "optional basis" till further notification, the latest notice added.
India had implemented the requirement of affixing bar codes on tertiary level and secondary level packaging with effect from October 2011 and January 2013 respectively.
The new rules, though, will not apply to those formulation exports, 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 subject to permission of the Drugs Controller General of India or his nominee. However, the tertiary level of packaging will require additional printing of a barcode as specified by India in addition to an importing country’s requirement.
References
- DGFI. Implementation of the track and trace system for export of pharmaceuticals and drug consignments, Jan. 5, 2016, http://dgft.gov.in/Exim/2000/PN/PN15/pn5216.pdf
- India notifies track and trace implementation for pharma exports, Scrip Regulatory Affairs, April 7, 2015
This article has also been published in Scrip Intelligence. Scrip Regulatory Affairs brings selected complementary coverage from our sister publications to our subscribers.