1. DRL CASE STUDY
Prepared by –
Astha Bishnoi
Ashutosh Ranjan
Diksha Uniyal
Nikhil Sharma
Nirankar Royal
Swimmi Alaska

2. 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

3. 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)

4.  Started research programs by investing 4% of
revenue
 Molecularrestructuring
 Set up new drug development research (NDDR)

5. 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

6. 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

7. 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

8. Contd:
OTC and NDDS
Value added and
Branded
Generics
Conventional
Dosage Forms
Commodity
Generics
Intermediate
and Bulk
Drug
Substances

9. 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

10. R & D expenditure of DRL
number
40
35
30
25
20
nu
15
10
5
0
2005 2006 2007 2008 2009

11. Patents granted in USPTA
number
60
50
40
30
number
20
10
0
UPTO 2005 2006 2007 2008 2009
2004

12. ANDA Fillings
ANDA fillings
60
50
40
30
number
20
10
0
UPTO 2004 2005 2006 2007 2008 2009

13. THANK YOU