International activists meetings with Generic Companies in Mumbai

[Guest guest]

ITPS Meetings with Generic Companies

Bob Huff will be preparing a detailed, printed report on the meeting

with generic antiretroviral drug manufacturers that occurred in

Mumbai, India this week, but I want to quickly offer some of my own

impressions from the meetings and urge others who attended to do so

as well.

1) What a wonderful group of people: I am continually amazed at the

intelligence, passion and commitment of treatment activists from

around the world. Everyone was just fantastic at the meeting. I am

a generally critical person, so I don't offer praise lightly.

2) The Indian patent law: the new Indian patent law may kill generic

production of antiretroviral drugs as the multinational companies

seek to patent their drugs under Indian statute and block Cipla,

Ranbaxy, Hetero, Strides, etc. from copying them. The older drugs

(e.g. AZT) may survive patent challenges, but even drugs like

Combivir (e.g. fixed dose combination of AZT/3TC) may be blocked

from further generic production in the future. Newer drugs like

tenofovir and the protease inhibitors are likely to be blocked from

generic production.

3) Price gouging: it is clear that a combination of local taxes, and

distributor mark-ups are driving the prices of generic medications

sky-high in many countries. The companies didn't offer any

solutions here and this may mean we have to seek other solutions to

this problem. First, is shining an light on these abuses, perhaps

in a website, which can be used to track excessive mark ups and

tariffs and pressure the guilty parties to address these issues. We

also have to seek national solutions to the tariffs and taxes issue.

4) Pediatric formulations: while some companies have either fixed

dose combos for kids or syrups, the lack of pediatric formulations

remains a problem. The companies seemed to need technical

assistance on these issues and Ben Cheng has invited them all to a

meeting on pediatric formulations in Canada that is happening in a

few weeks time.

5) WHO prequalification and bioequivalence studies: none of the

companies took responsibility for the withdrawal of their drugs from

the WHO prequalification list and they seemed to blame a change in

WHO standards for the situation saying that the BE studies on these

drugs were done a few years ago now and that WHO changed their

guidelines. They also blamed the CROs. In any case, they are

resubmitting their dossiers to WHO if they have not done so

already. They also blamed a lack of staffing at WHO for timely

review of their dossiers….

6) FDA-All of these companies are going to the US FDA to get

approval to use their drugs in the US PEPFAR program and Ranbaxy

looks like it is making FDA approval rather than WHO pre-

qualification a priority for them.

7) Prices: none of the companies would address pricing in any

significant way suggesting that the terms of pricing are based on

volume, long-term order commitments, etc.

More later, but just a snippet of what happened over two days….

Gregg Gonsalves

Email: greggg@...

Cross posted from

internationaltreatmentpreparedness/