Wednesday, February 26, 2014

More trouble for Ranbaxy

Ranbaxy Laboratories, once one of India's great pharma success stories, continues to be in trouble. Shipments of active pharmaceutical ingredients (APIs) from all four of its Indian plants, meant for export to foreign markets, have now been suspended. In effect, Ranbaxy can no longer export drugs to its biggest market, the US.

The bans were put in place by the US Food and Drug Administration (FDA), after Ranbaxy failed to meet FDA quality standards for their products. On a recent visit to India, FDA commissioner Margaret Hamburg made it clear that Indian pharma companies wanting to do business with the US will have to play by their rules. 
"If Indian pharmaceutical companies want to sell in the US, they need to comply with our standards, practices and expectations."
In case anyone thinks the FDA's being unnecessarily harsh, let me direct you to this excellent and painstakingly researched article that explains, in frightening detail, exactly what was going wrong at Ranbaxy's manufacturing plants.
"...Ranbaxy had to recall millions of pills after tiny glass particles were discovered in some of them."
"...the company culture was for management to dictate the results it wanted and for those beneath to bend the process to achieve it." 
"Lying to regulators and backdating and forgery were commonplace..." 
"The company not only invented data but also fraudulently mixed and matched data..." 
If these statements are true (and given the amount of research that's gone into the article, I think they are), I'm not touching a Ranbaxy-made tablet with a ten-foot barge pole until they clean up their act.

Sadly, this attitude of "regulations are meant to be bent and/or broken" is something I've come across before. When you're making medicines that are meant to cure sick people, those regulations are there for a reason. There are plenty of Indian pharma companies who rigorously follow all the rules relating to good manufacturing practices. But bad apples like Ranbaxy, who not only break the rules but thumb their noses at them, make the Indian generics industry look very bad indeed, and that's the kind of negative publicity we really don't need.

Thursday, February 20, 2014

An accelerator for genomics startups?

This week, the sequencing company Illumina announced a tie-up with Russian billionaire Yuri Milner to fund an accelerator for genomics startups. Illumina will provide lab space, sequencing equipment and $100,000 for initial costs of operation. Milner will provide additional financial support.

Seems like it's a win-win for both partners; Illumina builds the machines, and gets young entrepreneurs to discover cool things to do with them, in turn fueling demand for their product. Both Illumina and Milner will get good press as well. Milner, in particular, is already funding prizes for breakthroughs in physics and the life sciences, although the life sciences prizes, in particular, have so far largely been awarded to scientists who are already big names in their fields and are well funded.

The challenge in genomics, unlike some other areas of biology, is not so much the generation of data as figuring out what to do with it. It lends itself well to the current trend of "big data" and network analytics, and is definitely cheaper and faster than, say, generating a transgenic animal model to study a specific disease.  It'll be interesting to see what comes out of this collaboration, and whether there is potential for more such tie-ups between companies and private investors.

Thursday, February 13, 2014

Spurring innovation in Indian pharma-where do we start?

I had an interesting email discussion with well-known pharma blogger Derek Lowe, about the state of innovation in Indian pharma, and what kind of drug discovery model would work best for us.

The post itself, as well as the comments to this post are quite thought-provoking, and generally touch on two major points:

1. It's a bad idea to try and adopt the same pharma model as the big Western companies.
This should be pretty obvious, given that the global pharma industry is in a downturn, with empty pipelines, expensive failures and expiring patents. Which is not to say that a company run along those lines would definitely fail, but it's probably not the best use of our money. What should our model be, in that case? Suggestions ranged from having government-funded initiatives (like the Open Source Drug Discovery programme), to focusing on traditional Indian medicine like Ayurveda, soliciting funds from NGOs, working on disease areas most relevant to our country, and so on. Another more radical solution was that we stop looking at small molecules altogether, and focus on biologics instead. All of these approaches have their own merits, and it would probably need a combination of all of these and more to develop a flourishing drug discovery ecosystem in India.

2. It's too risky a business for Indians, who aren't very entrepreneurial anyway.
This is one argument I don't completely buy. Yes, in practical terms, it makes a lot more sense to try and build a software startup, since you don't need much by way of startup capital, and the chances of quickly building a revenue-generating product are higher. But there's no shortage of entrepreneurs here, and I've personally heard of several interesting start-ups in the life sciences space. What they really need, however, is solid financial support, whether it's from venture capitalists or even from the government. Drug discovery is an inherently risky, time-consuming and capital-intensive business which requires long-term vision from investors. Perhaps the way to make it more attractive an investment is to start small, with more modest goals-pick a small but relevant problem to solve. R&D can be balanced with, say, a generic drug/biologics production programme (Biocon is probably the best-known example) to offset risk.

To me, the idea that India continues to largely depend on foreign companies to do all the messy work of drug discovery is a dangerous one. There are so many contentious issues to deal with - drug pricing and patent validity being two big ones - that this relationship cannot continue to remain one-sided. We already have several big players in the pharma space, which is good news. But rather than letting the status quo continue undisturbed, it's a good time to start thinking about what we can do with our resources to allow more drugs to be developed in India.