The Indian pharmaceutical industry came into existence in 1901, when Bengal Chemical & Pharmaceutical Company started its maiden operation in Calcutta. The next few decades saw the pharmaceutical industry moving through several phases, largely in accordance with government policies. The development, present status and scope of pharmaceutical industry in India.

1. PRESENT STATUS AND SCOPE OF
PHARMACEUTICAL INDUSTRY IN INDIA
-MADHURA NEWREKAR
1

2. INDIAN PHARMACEUTICAL
INDUSTRY
 The Indian pharmaceuticals
market is the third largest in
terms of volume and thirteenth
largest in terms of value.
 India is the largest provider of
generic drugs globally with the
Indian generics accounting for
20 per cent of global exports in
terms of volume.
2

3. HISTORY
 The Government started to encourage the growth of drug
manufacturing by Indian companies in the early 1960 and
with the Patents act in 1970.
 However the economic liberation in 90s by the former prime
minister P.V.Narsimha Rao and then the finance minister Dr
Manmohan Singh enabled the industry to become what it is
today.
 The Indian pharmaceutical industry came into existence in
1901, when Bengal Chemical & Pharmaceutical Company
started its maiden operation in Calcutta.
 The next few decades saw the pharmaceutical industry
moving through several phases, largely in accordance with
government policies.
3

4. EVOLUTION OF PHARMACEUTICAL
SECTOR IN INDIA
4

5. PHARMACEUTICAL INDUSTRY
PHARMACEUTICAL
INDUSTRY
API
1.Largest segment
2. Second largest number in ANDAs
3.World’s leader in DMF application s with US.
CONTRACT RESEARCH AND
MANUFACTURING SERVICES(CRAMS)
1.Fragmented market with 1000 players
2.CRAMS industry is estimated to reach USD
18 billion in 2018
FORMULATIONS
1. Largest exporter of formulations in terms of
volume
2.Domestic market size USD 11.2 billion
3.Double digit growth is expected over the next
five years
BIOSIMILARS
The sector is expected to grow annualy at a
rate of30 percent.
5

6. CURRENT SCENARIO
 Leading pharma producer:
Indian pharmaceutical sector accounts for about 2.4 per cent of the
global pharmaceutical industry in value terms and 10 per cent in
volume terms.
 One of the highest exports:
India accounts for 20 per cent of global exports in generics.
 One of the fastest growing industries:
 Rapidly growing health care sector:
 Growing generics market:
 Ranked 5th in terms of attracting FDI:
6

7.  India has more drug-manufacturing facilities that have been
approved by the U.S. Food and Drug Administration than any
country other than the US.
 Presently over 80 per cent of the antiretroviral drugs used
globally to combat AIDS (Acquired Immuno Deficiency
Syndrome) are supplied by Indian pharmaceutical firms.
 The Indian pharmaceutical market is highly competitive and
remains dominated by low priced, domestically-produced
generics.
 The industry is export-oriented and the larger domestic
companies are competing in the global market for both
generics and original products.
7

8. GENERIC DRUGS,OTC AND PATENTED
DRUGS
 With 70 % of market share (in terms of
revenues), generic drugs form the
largest segment of the Indian
pharmaceutical sector.
 India supply 20 per cent of global
generic medicines market exports in
terms of volume, making the country
the largest provider of generic
medicines globally and expected to
expand even further in coming years.
 Over the Counter (OTC) medicines
and patented drugs constitute 21 per
cent and 9 per cent, respectively, of
total market revenues of USD20
billion.
8

9. Indian pharmaceutical market segments by
value
Top five segments contribute nearly 57 per cent to the total drugs
consumption
9

10. NOTABLE TRENDS
R&D :
 Indian pharma companies spend 8-11 per cent of their total
turnover on R&D
 Expenditure on R&D is likely to increase due to the
introduction of product patents; companies need to develop
new drugs to boost sales.
Export Revenue:
 India’s pharmaceutical export market is thriving due to strong
presence in the generics space.
10

11. Joint Ventures:
 Multinational companies are collaborating with Indian pharma
firms to develop new drugs.
 Cipla formed an exclusive partnership with Serum Institute of
India to sell vaccines in South Africa.
 Six leading pharmaceutical companies have formed an alliance
‘LAZOR’ to share their best practices, so as to improve efficiency
and reduce operating costs.
11
NOTABLE TRENDS Continued….

12. Expansion by Indian players abroad:
 Cipla, the largest supplier of anti-malarial drugs to Africa, set up a
USD32 billion plant in Africa for the production of anti-retroviral and
anti-malarial drugs.
 Sun Pharma, become the world’s fifth largest company worldwide
having 48 manufacturing sites more than 3000 marketed product.
Draft patents (Amendment Rules)2015:
 The time limit given for submitting the application for grant has
been reduced to 4 months from 12 months, providing an extension
of 2 months.
 Necessary permissions to be taken from the concerned authority
before the grant of patents.
12
NOTABLE TRENDS Continued….

13. Product Patents:
 The introduction of product patents in India in 2005 gave a
boost to the discovery of new drugs.
 India reiterated its commitment to IP protection following the
introduction of product patents.
Less time for approval:
 In order to compete with global players in pharmaceutical
industries, approval process of
 drugs have been simplified by the authorities and approval
time for new facilities has been
 drastically reduced
13
NOTABLE TRENDS Continued….

14. 14

15. TOP 10 PHARAMA COMPANIES IN
INDIA
1.SUN PHARMA
2.LUPIN
3.DR REDDY’S LABORATORIES
4.CIPLA
5.AUROBINDO PHARMA
6.CADLAC’S PHARMACEUTICALS LTD
7.DIVI’S PHARMACEUTICALS
8.GLAXOSMITHKLINE
9.GLENMARK
10.TORRENT PHARMA
15

16. TOP 5 COMPANY PROFILES
16

17.  It is an Indian multinational pharmaceutical company
headquartered in Mumbai, Maharashtra that manufactures
and sells pharmaceutical formulations and active
pharmaceutical ingredients (APIs) primarily in India and the
United States.
 Sun Pharmaceuticals was established by Mr. Dilip
Shanghvi in 1983 in Vapi with five products to
treat psychiatry ailments.
 The 2015 acquisition of Ranbaxy made the company the
largest pharma company in India, the largest Indian pharma
company in the US, and the 5th largest speciality generic
company globally.
17

18.  Lupin Limited is a transnational pharmaceutical company
based in Mumbai . It is the seventh-largest company
by market capitalization ;and the 10th-largest generic
pharmaceutical company by revenue globally. Lupin is the
fifth-largest generic pharmaceutical company in the US by
prescription-led market share and 3rd largest Indian
pharmaceutical company by revenue.
 Lupin was founded in 1968 by Desh Bandhu Gupta ,then an
Associate Professor at BITS-Pilani, Rajasthan.
 Lupin first gained recognition when it became one of the
world’s largest manufacturers of tuberculosis drugs.
18

19.  Dr. Reddy's Laboratories is an Indian multinational
pharmaceutical company based in Hyderabad, Telangana,
India. The company was founded by Anji Reddy.
 The company has over 190 medications, 60 active
pharmaceutical ingredients (APIs) for drug manufacture,
diagnostic kits, critical care, and biotechnology products.
 Dr. Reddy's originally launched in 1984 producing active
pharmaceutical ingredients. In 1986, Reddy's started
operations on branded formulations.
19

20.  Cipla Limited is an Indian multinational pharmaceutical
and biotechnology company, headquartered
in Mumbai, India.
 It was founded by Dr. Khwaja Abdul Hamied as
'The Chemical, Industrial & Pharmaceutical Laboratories' in
1935 in Mumbai.The name of the Company was changed to
'Cipla Limited' on 20 July 1984.In the year 1985, US FDA
approved the company's bulk drug manufacturing facilities.
 They are the world's largest manufacturer of antiretroviral
drugs.
20

21.  Aurobindo Pharma Limited is a pharmaceutical
manufacturing company headquartered in Hyderabad, India.
The company manufactures generic pharmaceuticals and
active pharmaceutical ingredients.
 The company’s area of activity includes six major
therapeutic/product areas: antibiotics, anti-retrovirals,
cardiovascular products, central nervous system products,
gastroenterologicals, and anti-allergics.
21

22. STATES HOLDING KEY
PHARMACEUTICAL VENTURES
22

23. STRATEGIES ADOPTED
 Cost leadership:
Players in the sector are trying to
achieve cost leadership in various
ways. For example,
Sun Pharma is trying to achieve the
same by
Vertical Integration: Complex API,
which require special skills and
technology, are developed and scaled
up for both API and dosage forms.
23

24.  Differentiation:
• In 2015, Lupin opened a research and development centre
for inhalation products in Florida, US.
• Sun Pharma is trying to develop technically complex APIs,
such as steroids, sex hormones, peptides, carbohydrates and
taxanes, which require special skills and Technology.
• Dr Reddy’s is investing in technology platforms. It acquired
OctoPlus N.V, a Netherlands-based company, to get access to
the Poly Lactic-Co-Glycolic Acid (PLGA) technology for the
formulation of complex injectables
24

25.  Focus on new markets:
Certain players in the sector are focussing on entering new
markets with new opportunities. For example
• Lupin is making inroads into new markets such as Latin
America, Russia and other East European countries.
• Sun Pharma decided to focus on specialty and chronic
therapies such as neurology, oncology, dermatology segments.
25

26. SWOT ANALYSIS
Key strengths:
 Cost competitiveness .
 Well developed industry with strong manufacturing base .
 Well established R and D infrastructure .
 Third largest English speaking scientific and technical manpower
in the world .
 Strong marketing and distribution network .
 Rich biodiversity .
 Competencies in chemistry and process development.
 No. Of DMFs filed with U.S. FDA : higher than Spain ,Italy, China
and Israel .
26

27.  OTC market : Approx. Rs. 35 billion , Growth 18 – 20 % .
 Manufacturing Facilities : Largest number of U.S. FDA
approved manufacturing facilities outside U.S.A.
 Alternative Medicine : Herbal ,Ayurvedic , etc. – about Rs. 38
billion .
 India will now have a TRIPS compliant patent regime . This
will help in attracting more foreign investment .
 Move towards a liberal price control regime : scope for profit
and growth
27

28. Major Weaknesses:
 Low investments in innovative R and D .
 Volume driven but low priced markets – limits value
realization .
 Low healthcare spends .
 Highly fragmented industry .
 Inadequate regulatory standards .
 Spurious drug sales .
28

29. Key Opportunities:
 Significant export potential .
 Licensing deals with MNCs for NCEs and NDDS.
 Contract Manufacturing for MNCs .
 Opening up of the health insurance sector .
 Potential for developing India as a centre for international
clinical trials .
29

30. Threats:
 2005 IPR regime implies drying up of product pipeline for
Indian Companies .
 Lack of R and D enabling regulatory environment .
 Pricing pressure imposed by DPCO .
 China threat .
 Loopholes in the patent Bill .
30

31. PHARMEXCIL-facilitating agency
for Indian pharma exports
 The Pharmaceutical Export Promotion Council of India(PHAREXCIL)
has been set up in 15.05.2014 by Government of India to promote the
Indian pharmaceutical industry around the world.
 Key functions of PHARMEIL:
1. Facilitation of exports of drugs , pharmaceuticals ,biotechnology
products, herbal medicines and diagnostics etc.
2. Authorized to issue registration-cum-membership certificate(RCMC)
which is one of the requirements for the importers and exporters of the
commodities.
3. Concerned with giving export thrust to the various products through
visits of delegations to various markets abroad ,organizing the
seminars ,workshops and exhibitions.
4. It also holds buyers/sellers meets and complies detailed data base to
the pharma exports and problems in exporting pharma products.
31

32. NPPP 2012
32

33. The main objectives of this policy are :
 Ensuring abundant availability at reasonable prices within the
country of good quality essential pharmaceuticals of mass
consumption.
 Strengthening the indigenous capability for cost effective quality
production and exports of pharmaceuticals by reducing barriers to
trade in the pharmaceutical sector .
 Strengthening the system of quality control over drug and
pharmaceutical production and distribution to make quality an
essential attribute of the Indian pharmaceutical industry and
promoting rational use of pharmaceuticals.
33
NPPP 2012

34.  Encouraging R and D in the pharmaceutical sector in a
manner compatible with the country’s needs and with
particular focus on diseases endemic or relevant to India by
creating an environment into R and D in pharmaceuticals in
India .
 Creating an incentive framework for the pharmaceutical
industry which promotes new investment into pharmaceutical
industry and encourages the introduction of new technologies
and new drugs
34

35. 35

36. OPPORTUNITIES
36

37. FUTURE GROWTH
 Competitive and technological changes in the pharmaceutical
industry-from powerful new drug chemistries to innovative
R&D partnerships and marketing plans-are reshaping the
business strategies of many pharmaceutical companies.
 India will see the largest number of mergers in
pharmaceutical and healthcare sector.
 The growth of Indian pharma companies will be driven by
the fastest growing molecules in the diabetes ,skin care and
eye care treatment.
37

38.  According to new research from the MIT Program on the
Pharmaceutical Industry (POPI), many companies today are
searching for ways to increase productivity, decrease costs,
and develop new treatment modalities that will enhance
profitability.
38

39. REFERENCES
 www.ibef.org ; India Brand Equity Foundation (IBEF) ;
January 2016;accesed on 15/6/17.
 Darekar A B et al ; Current scenario of Global and Indian
Pharmaceutical Marketing and Management ; Indian Journal
of Pharmaceutical Sciences ; 2016 ; volume 2 ;issue 2 ;Page
no : 95-100.
 www.asa.in ; A brief Report on Pharmaceutical Industry in
India ; July 2015.
 Gautam Arti and Khariya Anil , currrent scenario of
pharmaceutical industries in India.
39

40. THANK YOU
40