Comments on CDSCO’s Brand Name Extension Policies

Earlier this month, we had shared the news of CDSCO inviting comments on the long standing problem of Brand Name Extensions (BNE) practices. While this problem is one with severe consequences, it appears to have very little public discourse around it. Thanks to the quick work of 2 very industrious SpicyIP Summer School alumni, Rishabh Upadhyay and Umeshawari Ranjan, we were able to put together and send some comments just in time for the deadline. Instead of putting out the explanation and justifications for the need to address this problem (available in the submission, or any of the links below), I think merely pasting the example below shows the obvious issues – if one imagines that they or their loved ones are required to take any of these medicines regularly and may have life-threatening consequences if they are taking the wrong one!

Example 1:
Linamac (API: Lenalidomide, for cancer)
Linamac (API: Lenagliptin, for Type 2 diabetes)
Linamac D (API: Lenagliptin + Dapagliflozin, for diabetes)
Linamac M (API: Lenagliptin + Metformin, for diabetes)

Neither this, nor the other examples that we mention in the submission, are new. While the issues have not found their way in popular discourse, there is still a decent amount of writing on the area, much of which has already found some mention on the blog, for eg: Prashant Reddy & Dinesh Thakur (linked piece as well as of course their book The Truth Pill, more generally), Aparajita Lath, as well as Murali Neelakantan, Parth Sharma and Ashish Kulkarni, an earlier coauthored piece of mine with Murali Neelakantan, and this piece by Aditya Bhargava.

We hope that CDSCO does finally take some concrete steps to address this long standing problem!