Where is the India’s own blockbuster NCE? Or why there is not one !
In pharmaceutical industry the holy grail is a NCE finally approved and reaching blockbuster sales. As Gilead lifesciences has shown even a billion dollars a quarter could be an easily attainable figure for a new drug that meets a hitherto large unmet need and is efficaious. While developing markets may be targets for many pharma companies ( they show higher growth compared to developed markets), the reality is there is a dearth of companies outside the developed world which have NCE’s.
India itself has had mixed success here. While Ranbaxy’s Synriam ( an anti-malarial) could be the first NCE, Saroglitazar (Lipaglyn) by Zydus could be the true NCE. However Syriam had a non developed countries market and Lipaglyn has still not cleared any developed country drug regulator and has been approved only in India. That itself is a question mark?
Sun Pharma has licenced drugs in phase 2/3 and has its own pipline but there is still no billion dollar molecule drug there.
WHy does India lag? A couple of reasons come to my mind:-
a) Our late adoption of patenting of drugs:- Until 2000 or so India did not recognize drug patents. This gave a boost to the generics industry but also killed any incentive for genuine research. Thus few companies were serious in India about R&D until the late 90’s/early 2000’s
b) The drug life-cycle: It takes an estimated 18 to 25 years to bring a drug to market. Taking a) into consideration the time just hasnt come yet.
c) Costs: The cost to get a new drug to market is today nearly a billion dollars. The odds are also not great. Out of 1000’s of molecules screened , a 100 get selected for early studies and of them 5 make it to phase 1/2 and only one drug if lucky will get into phase 3 and final approval. These sheer odds were intimidating at a point where foreign drug makers subsidiaries ruled the market and no Indian company had the resources to invest.
Investments were made. It’s interests the NDDS division of Ranbaxy was retained by Daichi Sankyo and not sold to Sun Pharma. They saw the value
Today of course a host of Indian drug makers are lying in wait with phase 2/3 candidates. But a true NCE and a billion dollar at that is still far away.
Conflict of Interest declaration- I worked with Ranbaxy/ Sun Pharma earlier.