The Hindu Business Line : Will generic drugs from India dry up?

AS India enters the final-leg of its race to bring in the product patent regime, come January 2005, agencies working in health-related segments fear that "a major source to generic medicines is likely to dry up".

And the concern peaked last night, with the increasing likelihood of the Government bringing in product patents through an Ordinance.

"We are concerned about what is going to happen in India as it would impact the access to medicines of not just the people in India, but also in other developing countries," said Ms Ellen `t Hoen with Medecins Sans Frontieres or the `Doctors without Borders'.

Newer medicines would become more expensive and the 20-year monopoly that a product-patent grants to a company would make it difficult to bring down the price of medicines, she said on a conference call with journalists across the world.

Citing the example of anti-AIDS drugs, she said that the shift from the first line of treatment to the second line (involving newer drugs) would push up the patients' bill from $160 per person per year to about $4,000. In the past, generic or chemically equivalent AIDS drugs had played a pivotal role in forcing down prices in this segment.

Reacting to the likely Ordinance that would facilitate bringing in the product patent regime, given that Parliament may not take up the Patents Third Amendment Bill this session, Mr Anand Grover, Director with the Lawyers Collective HIV/AIDS Unit in India, said: "It is dishonest of the Government to do such a thing."

The reason: "There was no hurry, as we knew all along that the country was to go TRIPS-compliant by 2005. The Ordinance is worrisome as it would depend on what would be included. All we need is to bring in product patents for genuine products," he said.

But India is doing more than what is required as part of its international commitment, he said. "New usages or incremental developments on existing drugs should not be given patents. Other terms being used now are `near use' and such terms would only allow lawyers to make money by confusing the situation," he observed.

Ms Asia Russell, Director with the International Advocacy group Health GAP, observes: "Approximately 67 per cent of India's generics are exported to poor countries, the impact of India's changes will be felt both domestically and in importing countries. Unless the Government of India takes action to prioritise the protection of public health, both for Indian consumers and consumers in importing countries, drug prices will rise and lack of access to treatment for public health problems will worsen."