DRL CASE STUDYPrepared by –

Astha Bishnoi

Ashutosh Ranjan

Diksha Uniyal

Nikhil Sharma

Nirankar Royal

Swimmi Alaska

Basis of success of DRL prior to mid-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 Molecular restructuring 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:

Intermediate and Bulk Drug Substances

Commodity Generics

Conventional Dosage Forms

Value added and Branded Generics

OTC and NDDS

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

2005 2006 2007 2008 20090

5

10

15

20

25

30

35

40

number

number

Patents granted in USPTA

UPTO 2004

2005 2006 2007 2008 20090

10

20

30

40

50

60

number

number

ANDA Fillings

UPTO 2004

2005 2006 2007 2008 20090

10

20

30

40

50

60

ANDA fillings

number

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