Thursday, October 11, 2007

It all Action in India!

Over the last week, I have seen so many stories about big pharma operations in India. I can't help wondering if these are new news stories, or the Indian press is very good at highlighting the success India is having attracting and rapidly expanding a very active clinical research environment.

Wyeth, GSK Plc., AstraZeneca Plc., Pfizer Inc. and Sanofi Aventis, are just a few of the big pharma companies with their fingers in the Indian pie, according to reports just over the past 2 weeks. I'm sure it doesn't stop with those few companies. Additionally, the CRO market is also expanding at a rate of knots. One report suggest the Associated Chamber of Commerce and Industry of India (Assocham) projected the domestic Indian CRAMS (Contract research and manufacturing services) market will reach $ 900 million by 2010 and the demand in clinical research will grow from $200 million by end of 2007 to $ 1 billion by 2010 ( Pharma Industry in West Bengal: The Road Ahead). That kind of growth potential is enough to get any budding entrepreneur or company executive excited over the possibilities.

One has to ask - how does India plan to maintain control and quality with such rapid growth over so short a period of time. Just getting the trained staff (or training the staff) to meet that demand for services could only be described as an Everest climb at best. Initiatives like the recently announced launch of a new course by The Institute of Clinical Research (India), a global post-graduate diploma in clinical research in association with the Institute of Clinical Research, United Kingdom, will certainly help. But there is no better experience builder than time itself provides, in addition to formal training and mentoring.

If India knows the secret to managing this growth, then it's a secret we could do well to learn here if we are going to continue attracting clinical research to the Pacific and the opportunity that provides for Australia/NZ consumers to access the latest potential cutting edge treatments early.

It will be an interesting journey for all involved I suspect in developing a quality clinical research culture in all the developing nations, seen as the latest hope for controlling spiralling R&D costs through cheaper labour and expansive, relatively naive, population pools.

If these populations are not to be taken advantage of, it is important that consumers involved in the research are also well educated as to their rights, choices and the principles of informed consent. Big pharma and CRO's must take some responsibility in facilitating this education, if only to help develop trust and transparency in their intentions. Only educated consumers will make truly informed decisions about whether to participate in research, and not just participate because it offers a hope of treatment that they wouldn't otherwise have access to due to underfunded or non-existent health facilities. The challenge of educating consumers in a relatively well educated society such as Australia is difficult enough, without adding the challenges of language, education, poverty and access into the mix, as is the case in developing nations.

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