India’s Pharma Export Serialization Deadlines: April Fools!

animated ashok chakraOn 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 admit, I fell for it.  Did you?  In my essay on April 17 titled “India’s Pharma Export Regulations Update And The NECC Story” I said of the original notice,

“The new requirements will either result in the shutdown of the country’s entire drug export business, or they will force the Directorate General of Foreign Trade (DGFT) to push out the deadlines to avoid that business calamity.”

How embarrassing.  But in my defense, I did not know that the DGFT was such a big fan of April Fools’ Day.  And now, looking back, it seems so obvious.  I mean, look at the date it was published.  How could we have taken it seriously when it was so obviously impossible.  Or I should say, “how could I have taken it so seriously…”.  You probably caught what I missed.

Anyway, now we have the serious version with an effective date of October 1, 2015 rather than July, everyone exporting drugs from India had better pay attention.  I’m not sure an extra three months makes it workable, but this new serious version also says the following things must be done on an “optional basis” until further notice, which will help a lot:

  • human readable serial number on primary packaging (the serial number encoded within the barcode was already exempted until further notice);
  • aggregation data collection and reporting between primary and secondary packaging;
  • the barcode on mono cartons.

These were the things that made the April Fools’ version such a good joke.  My only complaint is that the DGFT took so long before letting us all know their first version was not intended to be taken seriously.  Good April Fools’ jokes usually start out sounding really serious and shocking–this one did a great job of that–but then, by the time you get down to the end, they make it clear that it’s just a joke.  Waiting an additional seven weeks before letting us in on the joke kind of takes the humor out of it.

Adam Fein is king of this kind of thing.  I look forward to April 1st every year because I know Dr. Fein will post a really great April Fools’ joke on his Drug Channels blog.  Here are some great examples to help the DGFT improve its act next year:

All classic April Fools’ jokes.  And even though yours wasn’t quite as good as Dr. Fein’s, thanks DGFT for that zany original document! Now I have two reasons to look forward to April 1st each year!


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?


  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.

Comments are closed.