# \[e-drug\] Barriers to generic ARVs in (South) Africa **URL:** \ **Category:** e-drug\ **Created:** [June 4, 2004, 8:21am UTC](https://talk.edrugplus.org/t/e-drug-barriers-to-generic-arvs-in-south-africa/19762 "2004-06-04T08:21:40Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![graya11](https://avatars.discourse-cdn.com/v4/letter/g/43a26b/32.png) [@graya11](https://talk.edrugplus.org/u/graya11)\ **Post date:** [June 4, 2004, 8:21am UTC](https://talk.edrugplus.org/t/e-drug-barriers-to-generic-arvs-in-south-africa/19762/1 "2004-06-04T08:21:40Z")
E-DRUG: Barriers to generic ARVs in (South) Africa ------------------------------------------------ [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](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 --- To send a message to Druginfo, write to: druginfo@healthlink.org.za To subscribe, write to: lyris@healthlink.org.za leave the subject line free and in the body of the message type: subscribe followed by your name and surname Or join online at: [http://lists.healthlink.org.za/cgi-bin/lyris.pl?join=druginfo](http://lists.healthlink.org.za/cgi-bin/lyris.pl?join=druginfo) To visit the list archives go to: [http://lists.healthlink.org.za/cgi-bin/lyris.pl?visit=druginfo](http://lists.healthlink.org.za/cgi-bin/lyris.pl?visit=druginfo) Enquiries and e-mail address changes: listadmin@healthlink.org.za -- To send a message to E-Drug, write to: e-drug@healthnet.org To subscribe or unsubscribe, write to: majordomo@healthnet.org in the body of the message type: subscribe e-drug OR unsubscribe e-drug To contact a person, send a message to: e-drug-help@healthnet.org Information and archives: [http://www.essentialdrugs.org/edrug](http://www.essentialdrugs.org/edrug)