When we watch the status of the present Indian pharmaceuticals industry and
hover into some details we conclude that we, the Indians, have made
considerable progress though the industry in global standard is quite small.
The active pharmaceuticals ingredients (APIs) used by the industry are almost
entirely based of patent –expired chemical entities many of which are produced
locally and many others are imported. India has over 25, 000 pharmaceuticals
factories, characterized by some 500 large industries contributing to 75% of
the market, the rest being contributed by
small and tiny companies. The number of formulations marketed would be
more than 60,000, which are being produced by the use of over 2500 APIs.
Because of the very large number of farms in existence and because of
public-friendly regulatory laws in existence, the prices of pharmaceutical
formulations in India are the lowest in the world. The finished formulations
conform to the standards of the Pharmacopeias. Indian formulations are widely exported
through the world including the developed nations, meeting part of the demands
of the countries where these are exported. Indian population is server fully by
the supply of these medicines at affordable prices. It is the APIs that make a
pharmaceutical formulation useful. Novel formulations are manufactured from
novel APIs which arise from new chemical entities (NCEs). While India uses over 2500 APIs which have
arisen from 12000 NCEs, very few of these have been invented by Indians. My
story is about those Indian heroes while I shall also narrate in the passing
about the status of our pharmaceutical industry.
The
importance of the Indian pharmaceutical Industry is globally felt, perceived,
recognized and respected.
Sixteen
years ago in September 2001, US was facing a monumental crisis – the World
trade center had just collapsed on Sep 11, and a week later the country was in
the midst of another attack – this time from biological spores called Anthrax.
Letters containing anthrax spores were mailed to several news media offices and
two Democratic U.S. Senators, killing five people and
infecting 17 others. According to the FBI, the ensuing investigation became
"one of the largest and most complex in the history of law enforcement ”.
While
this story was widely covered, and well-known to everyone, what is less widely
known is the role Indian Pharmaceutical industry played in helping the US
government deal with the Anthrax scare.
Anthrax
infection is caused by the spores of the bacteria Bacillus anthracis. These spores can be multiplied in labs and can
remain active for a long time. Isolated spores would look like white powder.
When inhaled or contacted with wounds or by eating food contaminated with the
spores these would cause the disease. Once infected, if prompt treatment was
not initiated, the outcome may be fatal!
Ciprofloxacin is the antibacterial drug of choice to treat the disease
the spores in powdered form were being posted along with letters posted to the
USA by the enemy in October 2001.
Because
of the emergency situation in the USA, there was suddenly a huge demand for the
antibacterial drug by the generic name ciprofloxacin. The drug was covered
under the US Patents Act and the patent right was held by the German pharmaceutical
company Bayer. The then US President George Walker Bush was to take a decision
on whether to waive the Bayer patent as it was clear that Bayer would not be
able to produce and supply the huge demand that had suddenly arisen due to the
anthrax scare in USA. The USA government which is pro-trade and is committed to
assure the drug companies to charge higher prices on the premises those
additional profits are means to generate additional funds necessary for
conducting future R&D was at a fix whether to override the Bayer patent in
order to enable USA to find alternate sources for the drug. The emergence
condition in the country was to be tackled at any cost! Interestingly, the cost of treatment for
anthrax by using Buyers ciprofloxacin would be USD 350 against USD 10 only, if
treated by using Indian ciprofloxacin! And some 12 million US citizens were at
risk! But yet the USA government did not back out but honored Bayer’s patents
right and did not purchase the generic version of ciprofloxacin from India or
any other cheaper sources! However, the USA cashed on the opportunity and
negotiated with Bayer on one to one basis asking Bayer to reduce the price of
ciprofloxacin tablets and was able to succeed. Bayer reduced their prices of
ciprofloxacin tablets substantially to meet the USA requirements.
The
fact that cost-effective, but equally potent ciprofloxacin drugs from Indian
companies were available allowed US to successfully negotiate with the world’s
leading Pharma giant Bayer. Bayer had to back down in the end.
But
what made such solutions from Indian Pharma companies available in the first
place? It is the history of innovation at Indian companies over decades that
has enabled them to reach that state, and that is often both unknown and
underappreciated in the broader world.
Over
the next couple of posts, I plan to share some of the innovations from the
Indian Pharmaceutical industry, and innovative Indians. Stay tuned!
REFERENCES
1) 2001
anthrax attacks. (2017, October 2). In Wikipedia, The Free Encyclopedia.
Retrieved 08:18, October 23, 2017, from https://en.wikipedia.org/w/index.php?title=2001_anthrax_attacks&oldid=803471554
2)
BBC
News-America's anthrax patent dilemma dated 23 October 2001,
3) Jill
Carroll and Ron Winslow , The Wall Street Journal, ETBayer to Slash by Nearly
Half Price U.S. Pays for Anthrax Drug-The Wall Street Journal,Oct 25, 2001- https://www.wsj.com/articles/SB1003966074330899280
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