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DRL CASE STUDY Prepared by – Astha Bishnoi Ashutosh Ranjan Diksha Uniyal Nikhil Sharma Nirankar Royal Swimmi Alaska
Basis of success of DRL prior tomid-90s Reverse Engineering Variant of new drug at low cost Process innovation Speed Looking at drug which have high growth and less sensitive to price fluctuation like anti-ulcerants Indian patent act, DCPO were favorable Two pronged approach towards export Exported to countries where patents had expired DRL adopted the route of exporting penultimate stage intermediates for bulk drugs
Contd: Weak intellectual property rights which facilitated reverse engineering Methyldopa – choice of product and timing of entry Foreign exchange regulation act Compare to US & Europe, production cost is less in India Produce bulk drugs where margin was good In 1990, dropping of anti-dumping charges which resulted in publicity Exploitation of HW act (ANDA)
Started research programs by investing 4% of revenue Molecularrestructuring Set up new drug development research (NDDR)
Post mid 90s Focus on two different segments Capacity expansion Building brands Manufacture generics going off patent and innovator tie-ups Distribution system was reorganized Joint ventures in foreign markets Countries with high population Per capita consumption of medicines is high Proximity to markets in near by countries e.g. Egypt, Brazil Drug patent law not strongly in force
Contd: Acquisition of brands instead of company for short-term growth Tied-up with US firms for exporting drugs Fully owned subsidiary in US Marketing join ventures in Brazil Co-marketing and development agreement with Par Pharmaceuticals
Contd: Drug discovery – focus on creating a lead molecule (NCE) and selling it. DRL acquired ARL because of which it got five complementary brand, 3 manufacturing plants & 450 trained field staff. Licensed to multi-nationals for clinical trials and marketing Focused on areas of growing concern like diabetes and cancer
Contd: OTC and NDDS Value added and Branded Generics Conventional Dosage Forms Commodity Generics Intermediate and Bulk Drug Substances
Post TRIPs Era Should focus more on R&D for new chemical entities (NCE) U.S. FDI compliant to harness the growth opportunity in areas of contract manufacturing and research as US$45 billion of drugs would go off patent by 2007 in us alone Increase in U.S. ANDA fillings Exploring new markets Tie-up with foreign companies to in-license drugs Acquisition to become big firm – Roche’s API business, Betapharm
R & D expenditure of DRL number 40 35 30 25 20 nu 15 10 5 0 2005 2006 2007 2008 2009
Patents granted in USPTA number 60 50 40 30 number 20 10 0 UPTO 2005 2006 2007 2008 2009 2004
ANDA Fillings ANDA fillings 60 50 40 30 number 20 10 0 UPTO 2004 2005 2006 2007 2008 2009