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
