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Access to ARVs in Developing Countries

Access to ARVs in Developing Countries. Dr. Arun Purohit Ranbaxy Laboratories Limited. The global need…. Bridge the treatment gap…. ±2 million*. Ideally 6.5 million. 10-15 million. WHO’s 10x10 or Pepfar’s “2x8” directional/motivational. * Media reports, June, 2007. The challenges….

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Access to ARVs in Developing Countries

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  1. Access to ARVs in Developing Countries Dr. Arun Purohit Ranbaxy Laboratories Limited

  2. The global need… Bridge the treatment gap… ±2 million* Ideally 6.5 million 10-15 million WHO’s 10x10 or Pepfar’s “2x8” directional/motivational * Media reports, June, 2007

  3. The challenges… • Externally • Several million patients to be started on therapy:1st line/2nd line/Paeds • Large volume of high quality drugs, when required, where required • Fragmented demands, more initially • Drugs tailored for compliance and longevity of treatment: fixed dose combinations & co-packs • Limited Funding => Each dollar counts • Internally • Limited setup time • => Existing facilities and skilled human resources for developed markets to be allocated $$$

  4. Ranbaxy response…….Corporate will!. • Opportunity • Create a significant difference in treatment landscape in DCs & LDCs • Establish Ranbaxy credentials as a responsible MNC generic company • => In 2001, Ranbaxy decided to use its infrastructure to facilitate access to affordable quality generic ARVs • Today • Over 400,000 patients worldwide on Ranbaxy ARVs • Leading supplier of ARVs to global NGOs, institutions & government programs • Agreement with Clinton Foundation to provide affordable ARVs in 62 countries • First in the world Pediatric 3-in-1 ARV dispersible tablet for children • 15 WHO pre-qualified and 3 USFDA approved ARVs • Over 380 approvals of ARVs across 50 countries, with 300 more in pipeline*

  5. How we delivered? • R&D competence to develop various innovative fixed dose combinations and generics • ARVs manufactured at very large manufacturing facility approved by the most stringent of regulatory agencies • Modular facility => capacity ramp-up • High volumes => economies of scale => Affordable ARVs • Regulatory capacity: ability to register products on all continents esp. in affected countries • e.g., >1000 approvals in Africa with an equal number in the pipeline • Access: Marketing and distribution infrastructure in the most affected countries => pre & post sales support • Ranbaxy has ground presence in more than 125 countries

  6. ARVs Product Portfolio * WHO pre-qualified ▪ USFDA Approved

  7. Availability across the globe RANBAXY ARVs have been exported to… AFRICA Zambia Ethiopia Mauritius Central Africa Republic Mozambique Nigeria Mali Senegal Benin Kenya Botswana Burkina Faso Cameroon Chad Congo Gabon Guinea Ivory Coast Madagascar AFRICA contd… South Africa Tanzania Burundi Morocco Togo Uganda Zimbabwe Ghana Egypt Malawi Mauritania Namibia Niger South East Asia India Cambodia China Hong Kong Malaysia Myanmar Philippines Thailand Vietnam Latin/Central America Columbia Dominican Republic El Salvador Guatemala Honduras Jamaica Mexico Peru Trinidad & Tobago Venezuela CIS Ukraine Kazakhstan

  8. The road ahead… • The required capability, capacity and domain knowledge for facilitating access and delivery is here • What could be improved • Harmonization of regulatory requirements across countries • Common goal for various treatment/funding agencies • Consolidation of demand • Centralization of procurement processes • Funding generic research and development for innovation • Innovator-Generic partnering to enhance access for newer treatments Our commitment continues…

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