The Hindu Business Line : `8% of patient allocation in clinical trials from India'

"I'm happy I left the country in `85, when things were probably at the lowest. And I'm happy that I came back in 2000, when things were beginning to change," quips Mr S. Kalyanasundaram, Vice-President, South Asia and Managing Director India of GlaxoSmithKline Pharmaceuticals Ltd.

"Kal", as he is referred to in industry circles, has steered GSK Pharma's local operations through 2005, when India transitioned into a regime where product-patents would be honoured and me-too versions of new medicines outlawed.

He now prepares for a new assignment with GSK International from January 2007. In his "exit" interview to Business Line, Mr Sundaram gives an insight into his "battle-seasoning" experience at the helm of the company - changing overseas perceptions of India and GSK here, from scepticism to credibility, in the six years he has been here.

How do you look back at your stint here, particularly the transition into the product-patent regime?

GSK India is almost 100 years old, with a lot of history and respect. But, as a company, there were lot of changes required within the company. The good thing is, people were looking for it.

The operations I've handled (in New Zealand and Singapore), were more sophisticated but much smaller. The scale, complexity and the ability to communicate and motivate, initially two-and-a-half thousand people in sales and later a larger force, was a defining experience.

GSK India's turnaround was more a leadership challenge than a business strategy. The company needed direction and when they knew that the management was there and willing to support them in the change, they made the rest happen. That's a positive experience for me.

But if you think that things are good here, the better times are yet to come. The inflection point, in terms of the country's prosperity and the parent company's focus on India for global activities, India is on the radar. The motivation is here, so all in all going out, it's been a battle-seasoning experience.

What are some of the milestones achieved by GSK Pharma in this period?

A major milestone experience for us was the commercial turnaround. As a company, from where we were to where we are now, more looking out, changing the culture of the company to become more market-oriented and the spirit of the company to support the field-force, is a major change.

When me and my boss Thyagi (Mr V. Thyagarajan) came here, the group was very sceptical of India as a country, GSK India as a company. Changing that scepticism, and when overseas people came and saw the talent and energy in the company, that was encouragement for them to bring global activities including clinical trials. Today if we make a statement, it is considered quite seriously. That amount of credibility for the country and the management as a team here (has increased).

Any milestones that you can quantify?

Within two years of us talking about clinical trials, outside the United States and Europe, India has become the largest trial centre. At the end of last year, we have something like eight per cent of patient allocation; the US FDA carried out an audit. There were no major adverse reports. This has created a confidence, so from phase III (clinical trials), we want to start considering earlier stages (of doing human trials).

If I have a vision for the science component of our activity, long term, given our strengths in chemistry (and I'm sure going forward, we will develop our strengths on the biology side as well), one day we should have a basic research centre of GSK. But for that to happen, the policy framework of the country should encourage innovation in India. We have the talent that companies like GSK are willing to utilise, the government should make this place thriving on science and knowledge.

Could you elaborate on the eight per cent patient allocation?

If there are 100 patients on a clinical trial, eight of them came from India. The US will probably be the largest, then Europe. (It is not from a business point of view, but from a confidence point of view, Indian trials are meeting good clinical practice standards.)

When I was in Singapore, we started clinical research for the company in Singapore at that time. And number of companies followed. If you want basic science to take deeper root in the country, bringing activities like clinical research or the off-shore GSK collaboration for cancer, amongst other things will facilitate this.

Our doctors are getting experience of the product when it is on experiment, getting an understanding of the underlying science behind the product, and because of researchers interacting, there is global networking.

What is the status on GSK's anti-diabetic medicine Rosiglitazone? Are you concerned at the flurry of litigations as the patent-regime gets off the ground?

On Rosiglitazone, it is a matter of intellectual property linked directly to the parent company. The exclusive marketing right was rejected. I am concerned on the pre-grant opposition issue, the spirit of the (Patent) law can be abused if left unchecked.

Last time you said success begets more success. So, has more work come to GSK India now?

In terms of volumes of clinical research, India will gain a bigger share of clinical activities. India and China have been identified as major sources for manufacturing and procurement of global supplies. Some of the European countries' back-office operations have come to India. So all in all, more and more work will come to India.

So will the new man in, Mr Hasit Joshipura, have it easier when he takes charge at the helm next year?

In a country like India, making a policy will not make all interested groups happy. For every issue, there are many dimensions that need to be appreciated, and our parent company appreciates that. There is more work to be done in areas like counterfeit medicines and labour reforms, for instance.

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