GPO to make
generic Tamiflu from January
Posted AtNationMultiMedia.com
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 |
