GPO to make generic Tamiflu from January

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The Government Pharmaceutical Organisation said it would start producing a generic version of Tamiflu in January so that the anti-viral drug is available in the event of a global influenza pandemic. Wanchai Subhachaturus, deputy managing-director of the state drug manufacturer, said the first batch of the drug, believed to be the best defence against a bird-flu pandemic, would probably come out at the end of January.

In the wake of the third wave of the avian-flu epidemic, the agency will start formulating its generic version of Tamiflu next week after the arrival of about five kilograms of oseltamivir, the active ingredient, from India.

When it achieves the best formula in terms of uniformity and dissolution, the GPO will start pilot production in January with about 100kg of oseltamivir, which will yield about a million capsules of Tamiflu by the end of January. Wichai said that was enough for 100,000 patients.

The generic drug will be equal to the original and of high quality, he said. The Indian pharmaceutical company that supplies oseltamivir is certified to global standards, and the GPO's own dissolution-profile tests have shown that the ingredient is 99-per-cent identical with the original.

The Medical Sciences Department will carry out bio-equivalent tests on humans to make sure the generic drug can be absorbed in the same way as the original so that it can be registered for mass production.

"There is no reason for the bio-equivalent test to fail with the 99-per-cent dissolution-profile test already passed," Wichai said.

But he said the GPO would be ready to produce the drug by February without the bio-equivalent study if a pandemic occurred sooner than expected.

The GPO has the capacity to produce about 400,000 Tamiflu capsules a day for 40,000 patients, and it can raise production capacity threefold if needed. He said one million capsules would have to be in stock in case of a pandemic.

"It will take us just two and a half days to produce that amount," he said.

Pisamorn Klinsuwan, the GPO's director of research and development, said Thailand was not required to seek permission from the drug's original producer, Switzerland's Roche Holding AG, because the company had not patented it in Thailand.

Despite the rise in price of oseltamivir's precursor, Shikimic acid synthesised from the Chinese spice star anise, the GPO is confident it can get a sufficient amount of the active ingredient from India.

The GPO has a long relationship with the company because it has also supplied ingredients for anti-viral drugs for HIV/AIDS treatment, Pisamorn said.

India's Times News Network recently reported that 90 per cent of the acid had been taken away by Roche, causing the price of the Chinese spice to jump from US$40 (Bt1,600) a kilogram to $700.

As a result, the oseltamivir supplier in India marked up the price of the active ingredient fivefold. The retail cost of GPO's generic version will less than double from Bt40 to about Bt70 per capsule.

"We are absolutely certain that we can launch the generic version of Tamiflu in Thailand on time," Pisamorn said.

The GPO is also negotiating with French and Chinese partners to produce influenza vaccines in Thailand in about three years.

Arthit Khwankhom

The Nation

November 04, 2005