E-DRUG: Barriers to generic ARVs in (South) Africa
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[The excellent analysis below (crossposted with thanks to Andy from
DRUGINFO) shows the difficulties that generic companies have in getting to
the market.
After clearing a long and delayed registration process, Cipla still has to
get a voluntary license (promised by Boehringer in December 2003 after a
deal with AIDS activists) before they can sell to the South African
government ARV programme.
Secondly, all need WHO prequalification if they want to sell their product
after December 2004 to one of the ARV projects supported by the Global Fund,
as the South African Drug Regulatory Authority is not considered "stringent"
by Global Fund. From all developing countries, so far only Singapore and
Malaysia have qualified as PIC/S countries. Interestingly, even the
efavirenz originator products of MSD have not yet been prequalified by WHO!
Finally, generics cannot be sold to PEPFAR projects unless they get FDA
approval...
The December 2004 prequalification demand by Global Fund is applicable to
ALL countries; I predict this is going to be a very serious hurdle for ART
projects globally! And they need that once-a-day 600mg efavirenz quickly!
Wilbert Bannenberg, E-drug moderator]
Hi all
The latest MCC list of new registrations for May 2004 (see
http://www.mccza.com/documents/12.01%20Notification%20of%20Registration%20Ma
y04%20v1.doc)
contains some urgently needed products:
* Aspen's didanosine 25mg, 50mg, 100mg, 150mg tablets
* Cipla's nevirapine 200mg tablet
* MSDs efavirenz 600mg tablet
These three products provide great examples of the tangled mess facing
procurement officials.
The Aspen product can be marketed if the company has a voluntary
license from the patent-holder (BMS). However, even if it is available
to the SA market, those buying with Global Fund monies will not be able
to purchase the product after 31 December 2004, unless it is
prequalifiied by the WHO. This is because the MCC is not considered a
"stringent" regulator by the GFATM ("stringent" being defined as a
member of the ICH or PIC/S). Those paying with US PEPFAR funds cannot
buy this product, as it is not approved by the FDA - an expedited
"registration" process has been set up, but quite how easy that will be
remains to be seen. However, what clinicians really want is not the
buffered tablets, but the enteric coated version - the BMS Videx EC is
awaiting final registration (has been for months), and there are as yet
no prequalified or registered generic EC versions available. Videx EC
has not been WHO prequalified, but is FDA approved.
Cipla's nevirapine would be a very useful alternative supplier to the
national programme, but cannot be sold until the company completes
voluntary license negotiations with BI. Once that hurdle is cleared,
GFATM funds can be used to buy it (even after December 2004 as the
product is already WHO prequalified), but PEPFAR funds cannot - the same
FDA approval process would be needed.
The MSD efavirenz can be launched immediately (stock is expected next
week), can be bought with GFATM and PEPFAR funds, but is not yet WHO
prequalified - in fact, MSD has not had any products prequalified. Aspen
has a license to make a generic, but still has to negotiate the MCC
hurdle (and probably most of the formulation process as well), as well
as WHO preqialification and FDA approval.
regards
Andy
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Dept of Experimental and Clinical Pharmacology
* Study Pharmacist
Centre for the AIDS Programme of Research
in South Africa (CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net
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