India lags in pharma innovation

Pharma is bullish on China. Lung, liver and stomach cancers are among the top killers in China says the WHO. Novartis AG is testing a clinical candidate to treat head and neck cancer widespread in southern China. JnJ’s portfolio includes clinical candidates for lung cancer and hepatitis B, endemic in China. Sanofi SA has a pre-clinical candidate to treat a form of liver cancer that is prevalent in China. 

In 2012, JnJ opened a drug discovery laboratory in Shanghai, which has developed pre-clinical candidates for lung and blood cancers and hepatitis B.  Novartis committed $1 billion in 2009 and 2014 to set up a new drug discovery center in Shanghai; last October, it began testing its first China discovered molecule to treat nasopharyngeal cancer on Chinese patients. Eli Lilly’s team of 600 drug discovery scientists is initiating clinical studies on a China discovered molecule to treat liver fibrosis.

Typhoid, Jaundice, Sickle-cell Anemia and diarrheal diseases like Amebiosis affect millions in India; how come there are no clinical or preclinical candidates to treat these diseases in the pipelines of Pharma? Yes, the market sizes are different; but pharmaceutical pricing in China does not compare well to what these companies make in the US and European Market on innovative drugs. Despite this, Pharma is investing in building Research and Development capabilities in China. Why have we not seen similar investments in innovative drug development in India?

Of course, it is entirely unreasonable to expect our own industry, which is primarily focused on selling copies of chemical and biological drugs invented by others at cut-throat discounted prices to think of undertaking such innovative efforts. Yes, I know; there have been a few attempts in the past, and we have a few clinical candidates in development, but do we really have the appetite to develop innovative therapies? More importantly, with great fanfare and focus on Make in India, what do we have to show in the area of development of New Chemical and Biological Entities? 

While there are a myriad of reasons, all relevant I am sure that have led to where we are, let me offer you a few to think about. 

First, drug discovery and development is risky proposition. I am sure you must have heard of the astronomical costs associated with the development of a new drug; much of this comes from failure of several candidates which fall by the wayside during the rigorous risk-benefit analysis when it comes to safety and therapeutic efficacy. Unfortunately, our understanding of business risk is very different. We take plenty of risk, but all in wrong places. Five years of inspection data from the US FDA conclusively proves that. 

Our pharmaceutical industry expects a return on capital deployed in 24 months (that is how long it takes to develop an ANDA), while drug discovery is a 10 year game. We just don’t have the business risk-appetite to compete; lets be honest about it. Drug discovery doesn’t yield results in five years, and most promoters who run Indian pharma do not have the patience to persevere in the long run; plain and simple. And those who try, focus on developing drugs for the western world, not diseases endemic to our country. 

Second, we don’t have the skills to conduct drug discovery. Yes, we have become masters at reverse engineering chemical entities, our chemistry skills are a force to reckon with. But drug discovery requires biology, in addition to chemistry. And here we fail miserably. Go to any college that offers a Science curriculum and evaluate our B. Sc. and M. Sc. graduates for their ability to function in a biology laboratory. You will see what I mean. Yes, we have a lot of hoopla about “Skill India”, but when was the last time you heard about training microbiologists in the context of that programme?

Third, the Chinese government played a key role in convincing ex-pat Chinese scientists from the west to come back to China and help establish the industry. It gave them generous grants, created world-class laboratory infrastructure and incentivized these folks to come back home. Anyone who has gone through the process of applying for a DST grant will tell you what a boondoggle it is. The bureaucrats who administer these grants are the last people who know anything about innovation. They are experts in creating red-tape and revel at it. It’s a fishbowl for patronage. So much for creating a conducive environment! 
Then there is the role of the academia in fostering research. Early stage research is largely done at educational institutions. How many universities do you know in India that focus on real research as evidenced by peer reviewed publications?  

Finally, the Chinese government overhauled its ageing regulator. It modernized its laws governing research, bought competent people from the industry to administer the regulatory agency and held them accountable (including hanging an official found guilty of bribery and corruption). The result is that CFDA’s standards align with ICH, internationally acceptable norms. It doesn’t promote two sets of standards, one for “Chinese market” and another for “export-markets” like we do. This is the single biggest reason why Pharma finds confidence in the function of the Chinese regulator; ask them confidentially about what they think about the CDSCO and you will know. 

So there, while we tout India as the “Pharmacy to the world”, China has leapfrogged us when it comes to developing novel therapies for indigenous diseases. Our priorities are finding solutions to deal with problems that we have ourselves created, like Multi-Drug Resistant Tuberculosis! And in this process, we have not only lost an opportunity to create effective solutions for Public Health, we have also lost out on creating thousands of well paying jobs for our youth. 

In the end, the argument I am making is simple. Our industry is facing tough competition from the Chinese and they have started climbing the value chain. Our industry made a lot of money monetizing First-to-File generic drugs in the western markets for more than a decade now, but have failed to invest in the long term. And so have the policy makers and administrators in the government who are responsible for investments in Public Health. 

Time to think differently, don’t you think? Niti Ayog, are you listening?

Dinesh S Thakur is a public health activist and chairman of Medassure Global Compliance Corporation.