52 Perspectives: “Pharma in India…Fear of the Unknown”
This week’s contribution to ’52 Perspectives’ comes to us from Jim Worrell, CEO of Pharma Services Network, Inc. and Ameristart.
Prior to Christopher Columbus’ voyage to the New World, many people thought the world was flat: Start sailing and you will eventually fall of the edge. Because no one had actually attempted to sail to the edge, there was a natural fear of the unknown.
This same fear is present in many pharmaceutical and biotech companies today with respect to outsourcing clinical trials and manufacturing to India. With each passing year more and more sponsors are sending studies to India, but I have yet to see the “rush” to India that it truly deserves (and that I continue to expect). All I can figure is that sponsors fear the unknown: few are willing to sail to the edge and see for themselves what an amazing opportunity awaits.
Like the IT industry of the late 90’s, the life science industry is being pushed in India’s direction. The combination of cost, knowledge, and patient availability make it just too attractive to deny. I saw a recent article discussing the worldwide demand for Oncology patients. Given patient availability, finishing a study in North America alone will require 5.1 years. Utilizing patients from emerging markets cuts this down to 1.9 years.
So why is there not the expected “rush” to India’s door? Fear of the unknown. Because India remains unknown, American life science executives have an understandable (but unfounded) fear of Indian quality, difficult FDA approvals, adulterated (or invented) data, complex informed consent requirements, different metabolism rates, and more. Maybe you just share my fear of navigating the Indian automobile traffic! Like Columbus in the 1400’s, Pharma executives today will find that personal exploration will put these fears to rest.
Fortunately for us, exploration is not what it used to be. India is unknown, but not unknowable. We can fly to Mumbai non-stop on 777s and sleep in 5-star hotels. The people of India are not only hospitable, they are down-right inviting! Very few places on the planet have people that will treat you as well as the Indian population. A welcoming spirit is part of Indian culture.
Yes, its true that India can induce culture-shock if you compare it too closely to the USA or Europe. India’s public façade of littered streets, gritty buildings, and dense populations is sometimes difficult for Western visitors. But I believe that we should experience the richness of the country for what it is, not what we want it to be.
Back to business…one of the hardest parts of doing business in India is identifying reputable, reliable, and FDA-audited service providers. You can attend all the trade shows you want, and this will not tell you 1/10th of the story that an on-site visit will tell. You must see first-hand how these companies work, their people, instrumentation, SOPs, cleanliness, and dedication. To remove the fear factor, you must ask questions, get answers, and determine for yourself if this is the place for your company to do business.
I encourage you to go to India as soon as you can. And if you find the thought still a bit daunting, please allow me to introduce our new service. Called PharmaTours, this service takes US sponsors to pre-qualified service providers, currently both clinical trial and CMC tours are available.
Its easy to remain blissfully ignorant. But the demands of the market do not allow us to do so. There are simply too many compelling reasons to check things out for yourself and make an informed decision if India is part of your company’s future.
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March 4th, 2010 at 2:55 pm
Unfortunatly Indisa is not only a distant second cousin in the world of Pharma but is has been slow to capture western buisness for problems
more closly associated with any major industry.
Change is slow to come. Old alliences are difficult to break. A new product from India, Its easier for us to just use the old reliable.
Enlightenment has to be perpetuated among western
buyers and suppliers. Staff has to be educated on the fact that India is a frontrunner.
And how much does good old jingoism play a part in regard to thia.
March 8th, 2010 at 8:29 am
The article is correct about fear of the unknown. That is why people like me help foreign companies in sourcing their requirements from India. It adds some cost but makes your task easy.
March 10th, 2010 at 1:09 am
Yes, to develop and find new horizon, should come front and understanding of capability is necessary. Most of the CRO, Pharma Companies already identified the potential of India as a platform for further business development. It has bank of knowledge, dedication, and diversity in population, hospitality and respect to the human as mentioned by Jae Chung. Thanks Jae.
Welcome to discuss more further to understand the requirements and capabilities.
March 10th, 2010 at 9:30 am
Jae, Jim,
Thanks for digging into an important topic. I think pharma partners will overcome their fears if the price, and quality, of Indian pharma is right. The explosion is happening, albeit more slowly than some have anticipated.
Paul
Paul
March 11th, 2010 at 9:44 pm
Based on our experience of running a CRO in India (Clininvent Research) over last 7 years, I can say that the scenario has been changing rapidly. The number of trials/centres keeps on grwing every year. Most CROs are aware of meetinng FDA exectations and have been making investments in site quality thru audits and training. It is difficult to FDA audited sites in India as FDA has begun inspections of Indian sites in 2005. FDA has inspected 9 sites of 5 are NAI and 4 are VAI. India is a new country but eager to meet global expectations.
March 16th, 2010 at 3:25 am
Dear Mr. Jae Chung, Mr. Jim Worrell,
Thank you for this wonderful, informative, insightful article. You have rightly commented that a country’s richness should be experienced for what it is and not what we want it to be. I too believe research should always be taken up with an open, unbiased mind.
I have more than 9 years’ experience in clinical trials (with CRO’s), out of which 5 years are in managing clinical trials. My most recent assignment has been with PPD as a Senior Clinical Team Manager.
I have seen that Indian CRO’s are keen to capture business from multinational pharma and to satisfy them with high standard of data quality.
India has periodically been the highest recuiter for many trials & has even come to the rescue of countries falling way behind their own recruitment targets. Besides the obvious fact of high patient population, this has been possible due to
- high quality investigator sites
- strong customer focus
- unflagging commitment to quality demonstrated by Indian clinical teams.
As the client contact person, I have seen that there is occasional recognition for good work performed by Indian clinical teams. Unfortunately, India is extremely complex and has its own set of issues – infrastructure, education, culture differences. India becomes difficult to decipher, even for the most seasoned ‘Westerners’. I can safely say that due to certain flawed perspectives, many a times the brickbats outweigh the bouquets. Now, it’s high time to change these misconceptions about India.
And truly, the hardest part is to ask questions & get answers. I hope your company can step in & make a valuable contribution in this direction.
With best wishes,
Sincerely,
Seema Syam