New
Delhi: Drug maker Roche Holding AG has granted a sub-license
to Hyderabad's drug firm Hetero Drugs in India to produce
Tamiflu (generic name oseltamivir) for developing nations.
This is the second such deal to boost output of the scarce
anti-viral drug.
Hetero
Drugs, has succeeded in becoming the first company in
India to obtain the licence to manufacture the bulk drug
for the Indian markets. Ranbaxy and Cipla are other Indian
companies, which had expressed interest.
Dr
Ashwani Kumar, the Drug Controller General of India has
said the licence for Ranbaxy Laboratories will soon be
given. He said Roche has also been given permission to
market the drug in India. "We just had three applications,
no other drug company applied," said Dr Kumar.
The
agreement with Hetero covers India and other developing
nations and allows the Indian firm to produce the flu
treatment specifically for governments wishing to create
emergency stores.
Roche's
decision to outsource the manufacture of Tamiflu to other
companies is due to pressure on the Swiss drug maker to
increase output as governments around the world are stockpiling
the drug, regarded as the best defence against the bird
flu pandemic.
Roche
said the agreement with Hetero would have an immediate
effect on the availability of the drug. Roche has also
granted a sub-license for the overall production of Tamiflu,
for pandemic use to Shanghai Pharmaceutical Group.
By
receiving a production sub-license from Roche, Hetero
has to adhere to the new legislation governing patents,
which comes into effect on January 1, 2005, in India,
Roche said.
Roche
holds an exclusive licence to produce Tamiflu, first discovered
by the US firm Gilead Sciences Inc. The World Health Organisation
has asked governments to create stockpiles of drugs like
Tamiflu, part of a class called neuraminidase inhibitors,
to protect their populations in the event of an outbreak
of avian flu.
Apart
from Chinese pharma company Shanghai Pharmaceutical Group,
Roche has identified 12 other partners in various countries
and is in talks with local players in these countries
including India for similar deals. These companies reportedly
include major pharmaceutical companies, generic manufacturers
and speciality chemicals producers.
The
bird flu virus also known as the H5N1 bird flu virus has
killed 70 people since it swept through Asia in 2003.
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