Monday, October 23, 2017
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!
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