Even as the D-day of July 1, 2014 for implementation of barcoding on primary pharma packaging comes closer, the exporters in the country have demanded to the union commerce ministry to keep the ministry's decision in abeyance. They feel that bar-coding on primary packs is neither practical nor possible and imposes a huge financial burden on the industry.
Pleading that the implementation of bar-coding at all levels of pharma packaging, especially on primary packs, is impractical both economically as well as logistically, the exporters have pointed out that barcoding on all stages of formulation packs is not implemented in any country. This is because many formulation packs like strips, vials, etc are so small that even mandatory details such as names of ingredients, warnings, batch number, price, name and address of manufacturer are very difficult to print.
Citing a US FDA example, exporters said that it is physically not possible to put barcodes on primary packs which was evident from the fact that a similar drug tracking system was dropped from the Generic Drugs User Fee Act in USA earlier, as even the largest pharma market in the world considered tracking every individual units as 'too expensive and burdensome for manufacturers, suppliers and healthcare professionals'.
Although the US has reconsidered the matter, US FDA has been directed to issue Guidelines by 1st January, 2015 so that trace and track on individual packs could be considered two years later, the industry informed the commerce ministry.
Bringing to the notice of the government about the financial burden, exporters said that every manufacturer and exporter will have to buy or upgrade machines, digitalise huge data and set up a whole new team which would require large investments and would be difficult to execute. The small and medium companies would not be able to afford setting up machinery that costs more than Rs. 1 crore and also requires additional manpower, the industry pleads.
The trace and track technology, which was adopted by the government to address the issues and apprehensions about the export of spurious drugs from India, was made compulsory for tertiary level packaging from October 1, 2012 and for secondary level packaging from January 1, 2013.
As per the latest notification from the ministry dated 5th April 2013, barcoding on primary package is to come into force from July 1, 2014.
Now the exporters have demanded to the commerce ministry to withdraw the notification or at least keep the notification in abeyance.