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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