The Biosecure Act

Can a proposed US legislation provide a shot in the arm to Indian Pharma exports? If so, how?

Source: Instagram

Have you heard of the Biosecure Act about to be made a law in the US Congress? 

Why does it matter to me, you ask? 

Because it has the potential to allow Indian pharma exports to boom. As you are aware, exports constitute a little more than 50% of the size of the IPM and if this was to boom, we could *really* become the "Pharmacy to the World". 

However, we are a people who don't need enemies. Our own kind cause us enough damage! 

Our companies continue to be plagued by quality issues. As a result FDA observations and 483s have continued. This is sad on two fronts: 1) We are doing this to ourselves with no compulsion from anywhere and 2) in the post pandemic world where most countries around the world shifted to a “China + 1” approach, Indian companies have/could have benefited greatly, especially in the pharma sector where exports to the US are a very important part of growth plans. 

In the case of Intas Pharma where serious lapses led the FDA to temporarily ban product imports from that site, the availability of basic chemotherapy drugs were hampered in the US. This led the country to evaluate (gasp!) Chinese companies like Qilu Pharma, to fill in the gap. 

Optimistically, I believe that this is a temporary measure and not one that is likely to impact Indian pharma exports. Why do I do that? Because very recently it was reported that Indian pharma exports to the US grew 15%. 

Returning to double digit growth is a significant achievement for the country considering stringent FDA requirements. This leads one to believe that most companies have succeeded in putting serious quality lapses behind them and barring Intas, the observations received by Cipla, Lupin and DRL were not crucial ones. 

That said, Indian companies must get their act together to be able to produce high quality generics and not allow higher costs deter them from doing so. 

And that brings us back to the BioSecure Act that you must know.

India must take advantage of the basic geopolitical distrust between the US and China which is playing out and recently highlighted via the WuXi biologics scandal. 

India is the only other large market with manufacturing scale to meet US requirements and it must continue to scale on the back on high quality products. This will need us to not shoot ourselves in the foot on every occasion, but work smart to understand the enormity of the opportunity that lies ahead of us. 

If we don't, like most things, we will have only ourselves to blame.

Have a great long weekend and a very Happy Easter!