India Defers Primary-Level Drug Serialization

India's Directorate Generate of Foreign Trade today officially announced a deferment of the primary level pharmaceutical serialization requirement which was originally slated to go into force on July 1, 2014.

Barcoding and serialization of other levels of packaging have already come into force, including Tertiary Level (October 1, 2011) and Secondary Level (January 1, 2013). The primary level serialization requirement would have added significant new complexity for pharmaceutical packaging.

Mono cartons which were earlier to be treated as part of primary level packaging are now to be treated as secondary level packaging instead. The self certification process which went into effect on May 15, 2014 stayed unchanged in the latest notice.

Yet to be announced but rumored to be in development is the design of the India track and trace reporting system for exported products.