The Indian pharmaceutical industry has grown significantly over time and is expected to reach $45 billion by 2020, making it the 6th largest pharmaceutical market. It has evolved over four epochs from 1850 to the present. Currently, anti-infectives make up the largest part of the market. The industry faces major challenges including competition from large multinational companies and generic manufacturers, government price controls, lack of strong intellectual property protection, and managing drug portfolios. However, the industry also provides opportunities such as growth in exports, partnerships with multinationals, and clinical trials. The major players are Sun Pharma, Lupin, Cipla, Dr. Reddy's, and Aurobindo, and the government supports

1. Indian Pharmaceutical
Industry
Presented By:
Shashikant Mathur
MBA- Ist Semester

2. CONTENTS
Introduction Regulatory Bodies
Evolution of Industry Major Player
Industry Overview SWOT Analysis
Major Challenges PESTLE Analysis
Import & Export Porter’s Five Force
Investments & Govt Initiatives References

3.  To analyze the current situation and major challenges of the Indian
pharmaceutical industry.
To identify major players of the Indian pharmaceutical industry and make a
comparative analysis of their business practices
Introduction

4. Evolution
The history of the evolution of the Indian pharmaceutical industry can be
divided into four principal epochs.
The first epoch is from 1850 to 1945.
The second epoch from 1945 to the late 1970s.
The third epoch for development is from the early 1980s to the early 1990s.
The fourth epoch spans from the early 1990s to the present time.

5. India's pharmaceutical sector will touch US$ 45 billion by 2020
. In the period 2002-2012, the country's healthcare sector grew three times
in size, touching US$ 70 billion from US$ 23 billion
. India's pharmaceutical market experienced a similar boom, reaching US$
18 billion in 2012 from US$ 6 billion in 2005.
the Indian pharmaceutical market will be the sixth largest in the world by
2020.
Industry Overview

6. Anti-infective has led the market with market size of Rs. 4973.1 crore.
Gastro intestinal market has stood at 2nd position following anti-infective with
value of Rs. 3500 crore.
Cardiovascular ranked 3rd with value of Rs.3480 crore.
Followed by respiratory, analgesics, nutrients and vitamins, gynecology,
neurology, dermatology, anti-diabetic and others.
Industry Overview

7. Industry Overview
Sr. No. Therapeutic category Market size
(in crores)
Expected growth
2008-2013
1 Anti-infective 4973.1 14%
2 Gastro intestinal 3500 14%
3 Cardiovascular 3480 15.90%
4 Respiratory 2880 10.40%
5 Analgesics 2840 7.40%
6 vitamins 2530 8.80%
7 gynaecology 1810 14%
8 Neurology 1760 12.40%
9 Dermatology 1750 12.40%
10 Anti-diabetic 1600 18.80%

8. Major Chellenges
Competition
First, obviously, “Big Pharma” companies compete among themselves
Secondly, “Big Pharma” companies experience significant profit losses due to
competition from the generic drug manufacturers.
Finally, the whole pharmaceutical industry competes with other health care
industries.

9. Price control
Pharmaceutical companies have to operate in a highly
regulated environment
government regulation for pharmaceutical companies is
price regulation
Major Chellenges

10. Protection of patents
Moreover, generic drugs manufacturers sometimes start production of
patent-protected drug analogues even before a patent expires.
Non-efficient legislation that does not provide the necessary level of
patent protection.
Major Chellenges

11. Drugs portfolio management
First, it takes an extremely long time to develop a new drug, and only a very
small portion of all projects is successful.
Second, insofar as patents keep exclusivity of drugs only during a limited
time, and soon after the expiration of the patent the sales of the drug sharply
go down.
Major Chellenges

12. Import
Year Value of Import of “Medicinal and
Pharmaceuticals Products”
Growth (%)
2003-04 2,956 3.18
2004-05 3,139 6.19
2005-06 4,515 43.84
2006-07 5,866 29.92
2007-08 6,734 14.79
2008-09 8,649 28.43
2009-10 9,959 15.15
2010-11 11,114 11.60
2011-12 14,385 29.43
(Source: Directorate General of Commercial Intelligence and Statistics (DGCIS), Kolkata)

13. Export
Year Value of Export of “Medicinal and
Pharmaceuticals Products”
Growth (%)
2003-04 15,213 18.61
2004-05 17,228 13.25
2005-06 21,230 23.23
2006-07 25,666 20.89
2007-08 29,354 14.37
2008-09 39,821 35.66
2009-10 42,456 6.62
2010-11 48,810 14.97
2011-12 63,347 29.78
(Source: Directorate General of Commercial Intelligence and Statistics (DGCIS), Kolkata)

14. According to data released by the Department of Industrial Policy and
Promotion (DIPP), the drugs and pharmaceutical sector attracted FDI worth Rs
60,100.91 crore (US$ 9.94 billion) between April 2000 and June 2014.
As per extant policy, FDI up to 100 per cent, under the automatic route, is
permitted in the pharmaceutical sector for Greenfield investment.
Hundred per cent FDI is also permitted for investments in existing companies
under the government approval route.
Investments

15. Government of India has also put in place mechanisms such as the Drug
Price Control Order and the National Pharmaceutical Pricing Authority to
address the issue of affordability and availability of medicines.
India plans to set up industrial parks in the pharmaceutical.
Govt Initiatives

16. Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare,
Government of India provides general information about drug regulatory requirements in India.
Drugs (Price Control) Order 1995 and other orders enforced byNational Pharmaceutical Pricing
Authority (NPPA),Government of India. View the list of drugs under price control.
The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in
India
The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India.
The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council
for Medical Research (ICMR)has come out with draft guidelines for research in human subjects.
These GCP guidelines are essentially based on Declaration of Helsinki, WHO guidelines and ICH
requirements for good clinical practice.
The Narcotic Drugs and Psychotropic Substances Act, 1985 is an act concerned with control and
regulation of operations relating to Narcotic Drugs and Psychotropic Substances.
Regulatory Bodies

17. Major Player
Net sales = 69.77 billion INR
Net sales = 66.86 billion INR
Net sales = 53.64 billion INR
Net sales = 40.15 billion INR
Net sales = 63.03 billion INR
Source: http://www.mbaskool.com

18. Strength
Cost Effective
Strong Manufacturing Base
Availability of high quality skilled workforce.
Excellent marketing and distribution network
Diverse ecosystem
Opportunities
Increased export potential
Marketing ties ups with multinational
companies to sell their products in
domestic market.
Immense scope to position India as a
centre for international clinical trials.
Key player in global pharmaceutical R&D.
Export of generic drugs to developed
markets
Weakness
Less investment in research and
development
Lack of coordination between industry and
academia.
Negligible expenditure on healthcare in the
country.
Manufacture of fake and low quality
medicines bring
Threats
Lack of investment in infrastructure
R&D restricted by lack of animal testing
and outdated patient office
Counterfeiting threat
Drug Price Control Order puts undue
pressure on product prices, affecting the
profitability of the pharmaceutical
companies.
The new MRP based excise duty regime
threatens the business of smaller
pharmaceutical companies
SWOT
Analysis

19. PESTLE Analysis
Source: http://www.strategic-planet.com

20. Porter's Five Force
Source: https://www.equitymaster.com

21. http://www.mbaskool.com
www.business-standard.com
https://www.equitymaster.com
http://www.ibef.org
http://www.strategic-planet.com
References