Indian Drug Exporters Ask For Halt Of Primary Packaging Barcode Regulations
Exporters in India are asking for the government to stop the implementation of its barcode packaging regulations. The barcode packaging regulations are set to take effect on July 1st, 2014, and a significant number of drug exporters have been lobbying the government for more time. The drug companies maintain that the packaging regulation is not practical, and some believe that it would actually be an economic impossibility to carry out. So far, the Indian government has remained steadfast in its commitment to regulate barcode packaging in the nation’s pharmaceutical industry, as it receives pressure from US regulators and other western drug makers.
The regulations would affect all levels of pharmaceutical packaging in India. Domestic pharmaceutical companies have stated that no other country requires barcoding on all stages of manufacturing and distribution. They’ve maintained that it would be extremely difficult to print barcodes on formulation packs such as strips, vials, and other small products. In many instances, drug makers say that ingredients, warnings, batch numbers, prices, names, and manufacturers’ addresses can’t all be printed on products because of how small they are.
The Indian pharmaceutical industry cited how the U.S.’s Generic Drugs User Fee Act dropped a similar tracking system, as it was considered too cumbersome, and too much of a financial burden for even the largest drug companies in the world.
New Indian regulations in 2012 and 2013 have already made trace and track technology compulsory for tertiary and secondary level packaging. Still, Indian drug producers are saying that they’ll have to upgrade machines and create huge digital databases for data if the July 1st date stays in effect.