India’s Pharma Export Serialization Deadlines: April Fools!

On May 22nd, 2015, India’s Directorate General of Foreign Trade (DGFT) quietly published Public Notice #13 with the subject “Implementation of the Track and Trace system export of drug formulations”.  It was an amended version of Public Notice #4, dated April 1, 2015 with a similar subject.   Get it?  April Fools! I have to

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3 thoughts on “India’s Pharma Export Serialization Deadlines: April Fools!”

  1. This is definitely not the first time DGFT have done this… Ever since the 2005 disaster with substandard medicine to Africa, the government has tried to save the reputation and re-brand “Made in India”. Serialization and aggregation down to primary level have been in scope since the very first draft, but industry also knows that this is, from a technical standpoint, nearly impossible and associated with high costs. Therefore the Primary Serialization has been postponed several times. However it’s not all a joke….. Recently meet up with an India Serialization Solution Provider with an integration track record of + 300 local packaging lines. Solutions which includes Second Level (Sales Level) Serialization and aggregation to pallet. Seen the system up and running with somewhat convincing performance. So India is definitely on the move, but try to imagine if you export out of India for China import! DGFT Serialization/aggregation to get out of the country and SFDA EDMC Serialization/aggregation to get into China….. What a mess….
    For India import we’ve had Codification since 2009, and it’s expected that there will be a later consolidation and standardization between Import/Export India.

    1. Lars,
      Thanks. Your points are well taken and I agree. I was just having a little fun. My only question in your interpretation is that I thought that the DGFT exempts companies from the Indian requirements when they are packaging drugs for export to countries that have enacted their own serialization requirement. In my view, that would include China, the U.S. and maybe even the E.U. Since these are some of the largest drug importing markets in the world, doesn’t that mean that the Indian requirements can be ignored most of the time as long as the target country’s requirements are being met?

      Dirk.

  2. Dirk,
    You’re absolutely correct about this. Clause 2.v of the most recent notification states that an exporter can obtain a waiver in case the importing country already imposes a specific requirement. However, the exporter must now obtain permission in this regard from the Drugs Controller General (the Indian FDA). The requirement to obtain permission was not there in prior announcements, so this is a new step. To Lars’ point, I would interpret this to mean that the exporter can follow say China’s mandate, but only after review and acceptance by the Indian authorities. There is no double jeopardy.

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