Monday, August 14, 2017

India lags in pharma innovation - China has surged ahead when it comes to developing novel therapies for indigenous diseases

Pharma is bullish in 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. Johnson & Johnson’s (JNJ) portfolio includes clinical candidates for lung cancer and hepatitis B, endemic in China. Sanofi SA has a preclinical 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 preclinical candidates for lung and blood cancers and hepatitis B. Novartis committed $1 billion in 2009 and 2014 to set up a new drug discovery centre 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 anaemia and diarrhoeal diseases like amebiasis affect millions in India; then 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 markets on innovative drugs. Despite this, pharma companies are 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 is 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 a 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 the 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 risks, but all in wrong places. Five years of inspection data from the US FDA conclusively prove that.

Our pharmaceutical industry expects a return on capital deployed in 24 months (that is how long it takes to develop an Abbreviated New Drug Application), while drug discovery is a 10-year game. We just don’t have the business risk-appetite to compete; let’s 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.

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. 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 expat 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 incentivised 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!

Finally, the Chinese government overhauled its ageing regulator. It modernised 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 the “Chinese market” and another for “export-markets” like we do.

China has leapfrogged India 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!
The author is a public health activist and chairman of Medassure Global Compliance Corporation. Views expressed are personal.

Source: DNA-10th August,2017