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Madhumathi D.S.

Bangalore , Nov. 10

TWO years ago, AstraZeneca Pharma India Ltd shook off the IDL tag and became a majority-owned subsidiary of AstraZeneca, one of the big 5 in the pharma world.

Although the Bangalore-based Rs 136-crore pharma company has quickly consolidated its operations and come back on the growth path through its portfolios in oncology, cardiovascular, respiratory and anaesthetic drugs, the course is not without issues, such as the avowed global goal of 100 per cent ownership. There are also problems unique to a research-driven MNC company, as Mr Lars Walan, Managing Director, says in this interview. Excerpts:

How has the year been so far?

We have done reasonably well. We are 1 or 2 per cent behind our targets, but I am confident that we will catch up. ... We have had an increase in sales of the order of 30 per cent (for the first half) compared to last year. The growth was due to a combination of factors such as refocussing on the product portfolio and training the sales force.

Which are the new products you have brought in?

Meronem (an anti-infective) that we launched last year is doing very well. This year, it was breast cancer drug Arimidex. Symbicort was launched a couple of weeks ago for asthma and Seloken XL (a cardiovascular drug) a few months ago. These are big areas and we are growing in them.

In recent months, domestic pharma companies have launched their versions of rosuvastatin. What chances would that leave for your anti-cholesterol drug Crestor in India?

Globally, Crestor is a very important rosuvastatin product and the best (in its category.) In India, for the reasons I mentioned, (its entry) is very uncertain. We are looking at what is happening in this small segment. If we had the same playing rules as in the rest of the world, it would have been a huge product. By definition of the IPR regime, such products will never get product patents (here).

Which will be your growth areas?

We will continue to strengthen our presence in oncology, respiratory, cardiovascular, maternal care and anaesthetic drugs. Oncology is an important area.

The company's global R&D pipeline is rich, particularly in cardiovascular and oncology. These happen to be areas of similarly big interest in India. Cardiovascular - including metabolic disorders - and oncology are perhaps of particular interest for the next medium term. We are strengthening our positions in those areas.

We have a slightly different approach in India due to the different market conditions now. Perhaps in 10 years, we will be more aligned with our global strategies.

Have you taken up clinical trials in India for new drugs?

That is an area of increasing importance to us. India is a fantastic market place for doing clinical research.

We have been active, though on a small scale, in involving India in global clinical trials. These are for products in phase 3 of trials. Yes, we have already started participating in global trials in three or four different areas, but I cannot talk about it.

Where does AstraZeneca India figure in AstraZeneca's global plans?

Currently, we (AZPI) are not visible. We are around No.35 among 100 countries (where the MNC operates) or less than one per cent of the total combine. But this will change. When that will be, I cannot say.

AstraZeneca has been focussed on the US, Europe and Japan but the focus towards Asia is changing. We have started to look at the emerging markets and see where it would be lucrative for us to put our money.

India does not come on top of that list - yet. But if the BRIC (Brazil-Russia-India-China) perspective is true, India can be in the top 10 league.

What have been your problems specific to India?

A number of positive regulatory policy steps have happened in the three years since I've been here. But there are still many hurdles that are unheard of in other emerging markets. Customs duty, for example. If India is serious about catching up with China, it must be much, much quicker in lowering the customs duty. Some of the drug prices are so high because the taxes are high. You must also remember that we (AstraZeneca) put $11 million every day in R&D. Think of the price differences, with a duty of 25 per cent here and four per cent in China.

Do you expect things to improve in the post-2005 TRIPS scenario?

The intents of the Government about implementing it are honourable, but there is a great amount of suspicion in the West about India's capability to live up to expectations. Knowing the situation in India, with so many domestic players (likely to get) frustrated by this, I can also foresee long-lasting legal battles that nobody has seen before. It happened in China, Brazil and elsewhere some 5-6 years ago. It's only that we are late. China has 100 times more patent lawyers than in India; the preparedness, the seriousness and the signals it sends to the world are different.

The IPR issue is the most important but most misunderstood thing. The focus now is on looking at what is at stake for the domestic pharma players who have not yet realised their potential and are engaged in copying and reverse engineering.

Unfortunately, I do not yet believe that India is prepared to implement it in a way that it is credible. It is India's last chance. If it does not (go ahead), then India will lose credibility in the developed world and that will be a disaster for India.

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