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FEATURE |
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| Cheap Indian AIDS Drugs under
cloud |
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| As India moves to meet a New Year's Day deadline to comply
with the Trade Related Aspects of Intellectual Property Rights
(TRIPS) regime of the World Trade Organisation (WTO), the cheap
generic anti-AIDS drugs that this country is famed for could
become a thing of the past. Ranjit
Devraj of Inter Press
Service Reports. |
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| New Delhi (India): On November 19, 2004,
the World Health Organisation (WHO) announced that the Hyderabad-based
pharmaceutical Hetero Drugs Limited in India, had voluntarily
withdrawn all six of its generic Antiretroviral (ARV) drugs
from the world body's list of approved drugs following concerns
about their laboratory tests. ARVs are substances used to kill
or inhibit the multiplication of retroviruses such as HIV. |
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| It was the third time since June that an Indian
company has removed anti-AIDS drugs following WHO inspections,
which claimed that bioequivalence tests - meant to show the
drugs have the same effect as the original patented brands -
were faulty. And this has deeply upset those involved in fighting
the global HIV/AIDS epidemic. |
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| Earlier in November, Indian pharmaceutical giant
Ranbaxy pulled its AIDS drugs off the WHO's list after the global
body also claimed there were discrepancies in the equivalency
tests. It followed the removal by India's pharmaceutical Cipla,
of two HIV/AIDS drugs in June for similar problems. |
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| Cipla is the Indian company credited with introducing
the 'dollar-a-day' treatment that dramatically transformed drug
access for HIV-infected people around the world. |
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| Both Ranbaxy and Cipla were able to prove to
WHO, before the voluntary pull-off, that their ARVs met the
global body's bioequivalence standards - though not before their
world business had taken a knock that benefited the manufacturers
of costlier patented drugs. |
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| ''We are concerned over the withdrawals. Earlier
it was WHO which dropped the drugs. This time the companies
are doing it own their own. We may ask the Drugs Controller
of India (DCGI) to look into the issue,'' a senior health official
told IPS. |
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| WHO's pre-qualification list was created to guide
procurement by aid agencies and donors interested in fighting
the global HIV/AIDS epidemic and includes more than 60 ARVs
made by both patented and generic drug manufacturers. |
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| According to the internationally-known drug policy
expert, Mira Shiva, the actual culprit in the whole debacle
involving Hetero, Ranbaxy and Cipla was actually the WTO and
not WHO. |
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| Shiva who is attached to the Voluntary Health
Association of India (VHAI), a leading health NGO, said Indian
pharmaceutical companies that specialise in cheap generics drugs
could face legal action, initiated by the WTO, if they continued
to manufacture and sell them after January 1, 2005. |
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| ''The TRIPS regime (in the WTO structure) has
been identified as one of the worst international trade regimes
and resistance to it in developing countries has come from farmers,
public interest and human rights minded social action groups,
as well as drug and health activists,'' Shiva said. |
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| TRIPS agreement, introduced in the late 1990s,
defines how products can be protected from piracy. A major criticism
has been that in its current form, Intellectual Property Rights
regimes (IPR) - like TRIPS - serve to stifle competition. For
poor nations it makes developing their own industries independently
more costly, if at all possible. |
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| ''Excessively high levels of intellectual property
protection required by TRIPS have shifted the balance away from
the public interest, towards the monopolistic privileges of
IPR holders,'' said Martin Khor of the Malaysia-based Third
World Network. ''This undermines sustainable development objectives,
including eradicating poverty, meeting public health needs,
conserving biodiversity, protecting the environment and the
realisation of economic, social and cultural rights.'' |
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| Shiva pointed out that a TRIPS review was due
in 2000 but was never carried out although the WHO was both
aware and concerned about the effect the regime would cause
to drug prices and access, especially in the developing countries.
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| So far, India's pharmaceutical business has followed
the fiercely nationalistic India Patents Act of 1970 that fostered
the phenomenal growth of the industry that came to be hailed
by the United Nations Council for Trade and Development (UNCTAD)
as a model for developing countries. |
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| According to a World Bank study in the mid-1990's
prices for four typical drugs were ten times more expensive
in neighbouring Pakistan, 17 times more expensive in Britain
and 37 times more expensive in the United States than in India.
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| The Indian law has safeguards for both inventors
as well as users but recognizes process patents as against the
product patents regime required by TRIPS/WTO. India signed the
relevant WTO agreement on the issue in 1995 as part of its economic
liberalisation. |
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| An amendment to the Act, designed to meet the
WHO deadline is slated to be tabled by the government during
the winter session of the Indian Parliament. If the government
fails to get a consensus, it is expected to resort to an ordinance.
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| Meanwhile, Poornima Mane, director for social
mobilisation and communication at UNAIDS, the UN body charged
with fighting HIV/AIDS said People Living with HIV/AIDS (PLWHA)
should continue using Ranbaxy and CIPLA drugs that are available
in the market. |
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| ''We want to clarify this so that PLWHA do not
panic. This (the voluntary withdrawals) does not mean that the
drugs are not good. The worst thing will be if people stop using
these drugs and develop resistance,'' she said. |
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| But Mane said both UNAIDS and WHO were monitoring
the situation in India ''since this country will have to follow
the WTO restrictions coming up next year and also because it
is the biggest producer of generic drugs.'' |
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| India itself has 5.1 million people afflicted
with HIV according to the 'AIDS Epidemic Update', an annual
report prepared by UNAIDS and WHO. Globally, the number of the
HIV-afflicted people has reached 39.4 million up from the 36.6
million estimated in 2002. |
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| © Inter Press Service. The feature
may not necessarily reflect the views of the United Nations
or its agencies. |
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| Inter Press Service (IPS), a leading
news agency, was set up in 1964 as a non-profit international
cooperative of journalists. In 1994, in order to strengthen
its non-profit identity, IPS changed its legal status to that
of a 'public-benefit organisation for development cooperation',
open to journalists, professional communicators and bodies active
in the fields of information and communication. |
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