PHA-Exchange> Generic AIDS drugs on UN list

[aviva]

      Generic AIDS drugs on UN list  
          
      Donald G. McNeil Jr The New York Times  Thursday, March 21, 2002 



 
Inclusion of products is setback for pharmaceutical giants 

PARIS In a move that delighted activists campaigning for cheaper AIDS
drugs, the World Health Organization on Wednesday made public its first
list of drug companies that meet its quality standards, and it included
a large Indian generic manufacturer and three smaller European ones. 
.
The decision represented a setback for major multinational
pharmaceutical companies, who want only patent-holders to be allowed to
sell drugs and decide what discounts to offer. It means that there will
be price competition among manufacturers of important anti-retroviral
drugs. Of the 41 drug formulations on the list, which included 11
anti-retroviral drugs and five drugs for the opportunistic infections,
funguses and cancers that attack AIDS patients, 26 were no surprise;
they come from the major international pharmaceutical manufacturers
GlaxoSmithKline, Bristol Myers Squibb, Roche and Abbott Laboratories. 
.
But 10 were from Cipla Ltd., the generic drug maker based in Bombay
that was the first to try breaking the patent monopolies of large
Western companies a year ago by offering AIDS triple-therapy for $350 a
year to charities and African governments. 
.
"I am delighted," said Yusuf Hamied, chairman of Cipla. "This proves
that we adhere to good manufacturing practices on a par with other
companies. It says Cipla is kosher, so now the multinationals can't
throw at us what they have said: 'They're Indian, they're Third World,
the quality might be iffy.'" 
.
Cipla products whose quality the WHO accepted include the
anti-retrovirals nevirapine; zidovudine, better known as AZT, and
lamivudine, better known as 3TC. Those three make up one common AIDS
cocktail. 
.
The WHO also accepted Cipla's acyclovir for shingles infections,
ciprofloxacin for bacterial infections and vinblastine and vincristine
sulfate for cancers. 
.
Companies were asked a year ago to apply for WHO approval, and teams of
inspectors from the WHO and Unicef spent up to two weeks at each
factory. Hamied said his factories around India have passed 22 U.S.
Food and Drug Administration inspections for various generic products
they make for the American market, so he was not surprised he passed.
He said he has several other drugs, including the anti-retroviral
stavudine, or D4T, that he said he hoped would make the WHO's next
list, which is expected in a few weeks. An Indian competitor, Ranbaxy,
which makes a three-anti-retroviral combination that it offers for as
little $295 a year to customers with 5,000 or more AIDS patients, did
not make the list. A company spokesman, Paresh Chaudhary, said the
company was not yet ready to export but hopes its factory in Dewas will
pass WHO muster in April. Its antibiotic-production-lines have already
passed U.S. inspections, he said. 
.
Dr. Bernard Pecoul, director of a campaign by Doctors Without Borders
to force drug prices lower, said he was "totally supportive" of the
WHO's inspection and approval plans and said of the first list,
"Theoretically, it's excellent because it creates competition." 
.
But he expressed frustration that some important drugs were missing.
There was not a single approved supplier for fluconazole, the
anti-fungal that suppresses cryptococcal meningitis, which gives some
AIDS patients agonizing headaches before killing them. 


+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

Dr. Unnikrishnan PV       (E-mail: unnikru at yahoo.com)
-------------- next part --------------
A non-text attachment was scrubbed...
Name: logo_v2.gif
Type: image/gif
Size: 5569 bytes
Desc: not available
URL: <http://phm.phmovement.org/pipermail/phm-exchange-phmovement.org/attachments/20020327/0170feef/attachment-0014.gif>
-------------- next part --------------
A non-text attachment was scrubbed...
Name: null.gif
Type: image/gif
Size: 43 bytes
Desc: not available
URL: <http://phm.phmovement.org/pipermail/phm-exchange-phmovement.org/attachments/20020327/0170feef/attachment-0015.gif>