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Drug Politics: WHO Attacks Indian Drug Manufacturers

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Dear Forum,

It smells something " fishy " in the whole businesses of

withdrawing anti-AIDS drugs from the market by Indian manufacturers

one by one; and recent WHO-attack on Indian drug manufacturers to

prove the bio-equivalence of generic ARV drugs these companies are

manufacturing. WHO-India hits at the right time when the entire

country is embarking on to upscale the free anti-retroviral treatment

for its HIV positive people. It seems there is a little

" politics " of procuring and selling foreign-made ARVs in the

gigantic market of the developing world including South and South

East Asia and Sub-Saharan Africa. The Indian manufacturers already

share a big proportion of HIV-drug market in these countries. The

striking correspondence of WHO's involvement in developing the

4th round Global Fund country proposal on ARV and its simultaneous

attack on indigenous manufacturers gives me a sense of global HIV-

politics, which I admit is a " guess " in the absence of any concrete

evidence. To prove that there is no politics involved, we must answer

the following few questions:

Why WHO came on heavily on the indigenous manufacturers to prove the

bio-equivalence of their drugs " only when " the country

planned to provide free ARV treatment to HIV positive people?

If WHO were so much obsessed with " ensuring quality treatment,

safety and efficacy of the drugs that people use, " why they could

not do so 5-10 years before when the indigenous manufacturers started

manufacturing these drugs?

If WHO is so " certain " about the quality and safety of these

drugs, how can they prescribe continue using these drugs in the

absence of any other? Is it not contradictory and unethical?

In the absence of these so called " banned " drugs that people

are already using which drugs will be used: foreign-made, India-made

or licensed trademark in India? What is their implication for drug

prices and affordability?

Why did Indian manufacturers withdraw their drugs after WHO-attack? I

guess they could not clinically prove the data WHO is asking them to

submit: it is all about few " well-managed " numbers and figures, and

not about how " good " or " equally " these drugs work as can be proved

from longevity in life-span, decreasing viral load, etc. It is also

not possible for the manufacturers to produce the data in short-term.

WHO indeed caught the right pulse of the manufacturers and hits them

where it hurts the most!! Do we need a WHO-policing on the quality

of " our " drugs at all? Why should we attribute such an

enormous " power " to an institution that bears so many question marks

on itself?

Sincerely

Subir K. Kole

---------------------------------------------------

Graduate Research Fellow

East-West Center- Center for Cultural and Technical Interchange

Between East and West Inc.

904-C Hale Manoa, MSC 836

1711 East-West Road

Honolulu, Hawaii 96848-1711

USA

Phone: + 808 944-6199

Email: subir@...

Website: www.EastWestCenter.org

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