SUSTAINABILITY REPORT 2013-15

People Overview Self Managed Teams Mechanisation Safety Overview The Parivartan     Journey Progress on     Roadmap Incident Statistics Robust Governance Standardised     Processes Enhanced Awareness Capability Building Safety Infrastructure Safety Audits Quality Overview Top-down    Accountability Quality by Design Quality Culture     Transformation Quality Assurance Quality     Best Practices All Time Audit     Readiness Availability Overview Strategic Sourcing Risk Management Product    Rationalisation Success stories Environment Overview Roadmap Energy Management Emissions Water Waste Case Study KPIs Community Overview Focus Areas Education Livelihoods Healthcare Infrastructure     Initiatives Creating Change     Makers Productivity Overview Productivity Streams Case Study PACE Update Initiatives Engineering Excellence Overview Digitisation Automation Mechanisation Lean Manufacturing Capital Equipment Strategy Predictive Maintenance Continuous Improvement Overview Continuous     Improvement     at Work Best Practices Annexures GRI Index Acronyms Assurance Statement   Summary Report     ECONOMIC PERFORMANCE AFFORDABLE & INNOVATIVE MEDICINE Overview    |    AIM Timelines    |    Global Generics    |    PSAI    |    Proprietary Products Global Generics It is ironical that on one side, science is making advances to find cures for untreatable diseases increasing the average mortality, while on the other, there are patients who are dying or suffering due to the unaffordability of medicines. It has been our continuous commitment to find innovative solutions that address the unmet needs of patients and to accelerate access to much-needed medicines for people around the world.   Our Global Generics business is a very important component in fulfilling that commitment, offering lower cost alternatives to higher priced drugs, either directly or through collaborations, to provide affordable and innovative medicines to enable people to lead healthier lives. It includes branded and unbranded prescription as well as over-the-counter (OTC) drugs.   To achieve these objectives, we pursue a three-pronged strategy:   Launching new products and promoting the growth of existing ones   Expanding to new geographies   Augmenting capabilities   New Products & Growth in Existing Products Geographic Highlights:   INDIA FY14 Approximately 15% of our Global Generics segment's revenues in the year ended March 31, 2014 were derived from sales in the Indian market. We continued to grow. Sales in India increased by 12.2%, outgrowing the Indian pharmaceutical market which experienced a growth of 9.9% during the same period. This growth was primarily fuelled by new product launches and an increase in sales volumes of key brands such as: Omez  |  Omez-DSR  |  Nise  |  Stamlo Reditux   FY15 India sales contributed approximately 15% to our Global Generics segment's revenues in the year ended March 31, 2015. The Indian growth story continued, clocking a 13.1% rise over last year's numbers, while the growth in the Indian pharmaceutical market in the same period was 12.1%. EUROPE FY14   Our sales of generic medicines in Europe for the year ended March 31, 2014 accounted for 7% of our Global Generics segment's sales. In Germany, we offer a wide range of generic pharmaceutical products under the 'Betapharm' brand, although the pharmaceutical market has a tender-based supply model instead of the prescription-based model. We market our generic products in the United Kingdom and other EU countries through our U.K. subsidiary, Dr. Reddy's Laboratories (U.K.) Limited. FY15 Europe sales contributed approximately 6% to our Global Generics segment's sales for the year ended March 31, 2015. In Germany, we continued to offer a broad range of generic products under the 'Betapharm' brand, although the tender-based supply model instead of the prescription-based model continued to hamper our ability to grow our market. United Kingdom and other EU countries were served through our U.K. subsidiary, Dr. Reddy's Laboratories (U.K.) Limited.   RUSSIA FY14 Russia accounted for 16% of our Global Generics segment's revenues in the year ended March 31, 2014. Our sales value and volume growths for the year ended March 31, 2014 were 7.7% and 4.1% respectively, as compared to the Russian pharmaceutical market value growth and volume decrease of 1.9% and 5.0%, respectively. The growth was driven by our top brands such as: Nise  |  Omez  |  Ketorol  |  Cetrine Ciprolet   Ibuclin, a cold and flu product, was switched from prescription to over-the-counter during the year. FY15 12% of our Global Generics segment's revenues in the year ended March 31, 2015 came from Russia. Our sales growth for the year ended March 31, 2015 was 10.1%. We continued to be the top ranked Indian pharmaceutical company in Russia in this period. The growth was driven by our top brands such as: Nise  |  Omez  |  Ketorol  |  Cetrine   'REST OF THE WORLD' MARKETS FY14 We refer to all markets of our Global Generics segment other than North America, Europe, Russia and other countries of the former Soviet Union, and India as our 'Rest of the World' markets. Our significant Rest of the World markets include Venezuela, South Africa and Australia. Our revenues from our 'Rest of the World' markets in the year ended March 31, 2014 showed an increase of 33% as compared to the year ended March 31, 2013. FY15 The business in Venezuela showed a great promise with sales value and volume growth for the year ended March 31, 2015 pegged at 149.7% and 141.2% respectively, as compared to the Venezuela pharmaceutical market value growth and volume decrease of 52.5% and 1.65% respectively. It accounted for 7% of our Global Generics segment's revenues in the last year.   N. AMERICA (USA & CANADA) FY14 During the year ended March 31, 2014, North America (the United States and Canada) accounted for 53% of our total Global Generics segment sales. We also started supplying products for private label customers for prescription products this year.   FY15 North America (the United States and Canada) accounted for 54% of our total Global Generics segment sales during the year ended March 31, 2015. In December 2014, we acquired from Novartis Consumer Healthcare Inc., the title and rights to its Habitrol® brand (an over-the-counter nicotine replacement therapy transdermal patch) and related U.S. marketing rights.   ANDA Dashboard We constantly seek to expand our pipeline of generic products. During the year ended March 31, 2015, we filed 13 ANDAs in the United States, including 8 Paragraph IV filings. During the same period, the U.S. FDA granted us 6 final ANDA approvals. As of March 31, 2015, we had filed a cumulative total of 220 ANDAs in the United States, out of which 68 ANDAs were pending approval at the U.S. FDA, including 8 tentative approvals. As of March 31, 2015, we had also filed two NDAs, one of which is tentatively approved and awaits final approval. We have also filed two new Investigational New Drugs (INDs) - our proposed biosimilars to Rituximab and PEG-GCSF. We have received permissions from the U.S. FDA to conduct Phase I trials for both of these IND filings. The trials are under progress for both IND approvals. During the year ended March 31, 2015, we in-licensed three ANDAs in the United States, of which two are Paragraph IV filings. As of March 31, 2015, we have in-licensed a cumulative total of five ANDAs in the United States, out of which four were pending approval with the U.S. FDA.   New Geographies Accessibility is key to our motto of Good Health Can't Wait. To accelerate the access to much-needed medicines for people around the world, we are committed to expand to more areas, alone and with collaborations. ALLIANCE WITH GSK Our alliance with GSK continues to expand our reach to emerging economies and new geographies. The products are manufactured by us, licensed and supplied to GSK in markets such as Latin America, Africa, the Middle East and Asia Pacific, excluding India.   PARTNERSHIP WITH MERCK SERONO The partnership with Merck Serono is poised to expand our presence in the bio-similar space in select emerging market countries. As part of the collaboration arrangement, we are currently conducting early product development, technology transfers and Phase I trials.   CHANGES IN OCTOPLUS N.V. OPERATIONS We have acquired the Netherlands-based specialty pharmaceutical company OctoPlus N.V. in the year ended March 31, 2013. OctoPlus was previously engaged in our internal drug development projects as well as providing pharmaceutical development services to external customers. During the year ended March 31, 2015, we decided to significantly increase the utilisation of OctoPlus' technical know-how plus its time and effort on internal drug development projects, and to scale-down its external pharmaceutical development services.   New Capacities We are dedicated to increase the availability of affordable medicine by augmenting capacities, leveraging technology and increasing production efficiencies. We are in the process of obtaining approvals from the U.S. FDA for products to be manufactured at our recently commissioned oral solid dosage form facility in a SEZ in Devunipalavalasa, Srikakulam, Andhra Pradesh, India. We have expanded our biosimilars facility in Hyderabad, Telangana, India to meet the growing demand in emerging markets. We have set up and commissioned a new manufacturing facility in a Special Economic Zone in Duvvada, Visakhapatnam, Andhra Pradesh, India, for the manufacture of parenteral (injectable form) products.   With this, as of March 31, 2015, we have 13 manufacturing facilities within this segment. 11 of these facilities are located in India and two are located in the United States (Shreveport, Louisiana; and Bristol, Tennessee). We also have one packaging facility in the United Kingdom.