The Hindu Business Line : Pfizer evaluating products for launch in India

THERE may not be a flood of new drugs into the Indian market, once the product-patent regime comes into force on January 1, 2005 — but the date is not going unnoticed either.

Pharma major Pfizer, for instance, is evaluating products that could be introduced in the Indian market, following the introduction of the patent-protected regime.

The Indian arm, Pfizer Ltd is currently in a "business dialogue" with parent company Pfizer Inc to assess what products would be introduced in India and when, Pfizer Ltd top brass told Business Line.

Multinational pharma companies have in the past said that the lack of patent protection had thwarted the flow of investments and new drugs into the local market.

The country has steadily progressed towards putting in place a framework to protect intellectual property rights (IPR) and this development is being watched closely by the multinationals.

"The company is evaluating all its products that are launched worldwide," said Dr Shoibal Mukherjee, Senior Director, Medical and Research Division, Pfizer Ltd.

However, he indicated that the decision-making process will be guided with more than an element of caution, given that several regulatory issues are still to be ironed out.

It is also a question of balancing the parent company's commercial interests with the local arm's capacity to deliver these products, Pfizer officials said.

Meanwhile, a similar situation arises in the case of bringing more clinical trial projects into the country as well, says Dr Mukherjee.

"We started doing clinical trials in India in 1995, with a couple of molecules and now there are about 20 projects in the country, in segments such as psychiatry, cancer, ophthalmology and infectious diseases," he said.

And though there is potential to bring in much more work from the global parent, efforts in this direction get delayed by the lack of clarity on IPR-related issues.

Despite India having an advantage in terms of "the quality matrix, the hospital sector and the ethical requirements," it ends up losing out to East European countries, besides countries such as Singapore and Taiwan on issues related to capacity and accessible markets, he said.

Patent protection regimes are already in place in the East European countries and countries like Taiwan allow easy market access, since they are smaller markets, he said and added that India would have to be much more dynamic if it wanted to mark its presence worldwide.

At present, India accounts for less than one per cent of the global pharma market.

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