1. Status of national production capacity of generic medicines – private sector perspective Aruldass Nithyanathan Zambia Pharmaceuticals Business Forum nithya@bpmcl.com Zambia TRIPS workshop 3 Oct 2013

2. Manufacturing Facilities in Zambia There are 5 facilities in Zambia having ZAMRA’s licence to manufacture Pharmaceuticals. IV Fluid (LVP) Sterile injectables (SVP), eye and ear drops Non sterile products –Tablets, Capsules, Liquids, Ointments & Creams and Powder ( sachets) Beta lactum Injectables and beta lactum non sterile products

3. Installed Capacity per Annum Tablets – 2 billion Capsules – 50 million 100ml Oral Liquids – 20 million bottles 2.5 ltrs Bulk packing Oral Liquids – 200000 jerry cans Powder Sachets – 30 million sachets Disinfectatnt / Antiseptic solutions – 10 million packs Ointment and creams – 1 million packs IV Fluids – 3 million packs Ampoule Injectables – 10 million packs Vials injectables – 10 million pack Eye and ear drops – 2.5 million packs Dry Powder Betalactum Injection – 6 million packs Betalactum Pediatric dry syrup – 3million packs

4. Capacity utilisation Over 200 different products are licenced by ZAMRA Capacity utilisation ranges from 30 – 70 % of installed capacity Only one plant has the long term contract with MoH. Others produce to compete - in the private market with other importers. - compete in the MoH tenders with other international suppliers.

5. Challenges With in  Lack of expertise in the country  Dependency on the manufacturing inputs from abroad.  Lack of service and maintenance support for the equipments.  Holding high level of inventory  No R & D facility Government  Duty up to 25% and VAT 16% on the manufacturing inputs and machineries.  Lack of deliberate enforcement policies on certain LAW.  Insufficient preference for local manufacturers  Poor payment practices for the goods supplied External High cost of borrowing Cost of electricity and fuel Cheaper imports Market size Support industries

6. WAY FORWARD Local Industries to upgrade the facilities Exempt duty and VAT on the inputs Identify and Protect locally produced products – Float tenders for locally manufactured products exclusively Tax Incentives for the existing companies – not only for the new Investors

7. Acknowledgements: ZPBF, Pharmanova (Z) Ltd, IDC ltd, BPMCL & Tejay Pharma THANK YOU Aruldass Nithyanathan nithya@bpmcl.com