Barcoding Regulation For India’s Domestic Drug Supply

India has recently made moves to impose a new barcoding requirement for all drugs procured by state and federal governments for domestic public consumption.  The new requirements are part of the preference to “Make In India” program that is intended to “…promote manufacturing and production of goods and services in India with a view to enhancing income and employment.”

On January 1, 2019 the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals published Policy #31026/4/2018, which establishes deadlines for the minimum percentage of ingredients for drugs that are marketed in India.  Apparently, drugs that do not meet those minimums will no longer be included on the list of drugs acceptable for procurement.  At least, that’s my interpretation of the program.

The Policy includes a description for how to calculate the percentage of “local content” for your drugs.  Drugs manufactured in India have a different requirement (percentage) than drugs NOT manufactured in India.  For drugs manufactured in India, the minimum local content percentage scale is:

For drugs not manufactured in India, the minimum local content percentage scale is:

You can download a copy of this Policy here.

But I’m guessing they quickly realized there was a problem with this plan.  How can you quickly tell which drugs are compliant, and which are not?  The original Policy did not contain a bar coding requirement.  So two weeks later, on January 14, 2019, the same Department of Pharmaceuticals issued a partial modification to the original policy that spelled out a new barcoding requirement.  You can download a copy of this notice of modification here

That modification set a deadline of April 1, 2019 for drug manufacturers marketing drugs in India for public procurement to add, what they call, a “barcode/ QR code” on their packages.  The barcode/ QR code must contain the following data:

  • Name of the product including strength;
  • Brand name (if any);
  • MRP (Maximum Retail Price);
  • Name and address of the manufacturer;
  • Batch number;
  • Manufacturing date;
  • Expiry date;
  • Special storage conditions (if any); and
  • Manufacturing license number.

(Note in particular that there is no serial number.  This is not a serialization mandate…yet…but see “India Proposes Serialization of Domestic Drug Supply”.)

Obviously, this is too aggressive for manufacturers to meet, both in terms of timeline and barcode data content.  This type of data should be contained in a database with only the product identifier (preferably a GS1 Global Trade Item Number, or GTIN), Batch Number and Expiry date included in the barcode.  But that assumes internet access at every point in the supply chain—particularly at all pharmacies.  This may not be the case in India. 

So far the Department of Pharmaceuticals has not faced the problem of the volume and formatting of the data in the barcode yet, but they have realized that the original deadline was way too aggressive.  So, on February 1, 2019 under Policy #31026/45/2016, they pushed out the deadline to “April 2020”, giving companies an extra year to meet it.  I can’t share the copy of this document because I can’t find it yet on the open internet, but I have seen a copy through my membership in GS1 Healthcare.  It appears that the Department of Pharmaceuticals hasn’t yet had time to post it on their website at this moment.  Check back on that site in the coming days because that is where I believe it will show up when they catch up.  Or, if you are a member of one of the pharma industry associations in India you can check with them because the Policy contains a long list of CCs to those organizations.

The fix to the deadline may be sufficient for companies to prepare, but that assumes the Department of Pharmaceuticals provides some indication in the near future of the formatting of this data.  We will likely see GS1 Healthcare raise concerns about the lack of a GTIN and the use of a QR Code for product identification, rather than the GS1 Datamatrix that is in use pretty much everywhere else.  GS1 and others will certainly object to the data contents.  Depending on how long the Department of Pharmaceuticals takes to address these concerns and publish more technical details, the new deadline may not be long enough. 

The government of India has a long history of imposing impossible deadlines, and then pushing them out, sometimes multiple times, and providing insufficient information needed to implement (see “India Posts New Deadlines (Again) For Serialization Of Drug Exports”).  This looks like it might be another one of those times.