The document discusses the Indian chemical and pharmaceutical industries. It provides an overview of the industries, noting that the chemical industry contributes 7% to India's GDP and the pharmaceutical industry is the 3rd largest by volume globally. The pharmaceutical industry is growing at 15-20% annually and is expected to reach $100 billion by 2025. The document outlines the major categories and companies in the industries. It also discusses opportunities in the industries such as clinical research outsourcing, exports, and research and development. Finally, it describes various career opportunities and skills required for different roles.

1. -Dr. A. Amsavel
02/25/16 1

2. Content
Indian Chemical Industries
Indian Pharmaceutical Industries-An over view.
Opportunities
Knowledge & Skills
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3. Indian Chemical Industry
Indian Chemical Industry plays a major role in the overall
development of India
Contributes significantly to India’s economy under
manufacturing sector
It accounts for approximately 7% of India’s GDP.
Output value in the year 2012-13 was 782,949 crores
Indian chemical Industry is 6th
in the world and 3rd
in Asia
India’s exports of chemicals (excluding pharma) was 32.02
US$ billion in 2013, and imports US$ 46.01
Chemical industry growth rate of over 8-11% p.a. and
expected to reach $290 billion by 2017
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4. Chemical industries- Category
The chemical industries broadly categorised;
Basic inorganic & Organic chemicals
Specialty chemicals & fine chemicals
Petrochemicals & plastics,
Pesticides & Agrochemicals,
Fertilizers
Dyes & pigments
Paints & varnishes,
Soaps, perfumes & toiletries and
Pharmaceuticals and others
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5. Indian Pharmaceutical industry- overview.
Indian pharmaceutical industry is growing fast as
like IT industry.
Manufactures Quality Medicines at affordable cost.
Significant growth is from 1990’s
Market size is about 2 lakhs crore
It is 3rd
largest in the world by volume (10%) and 13th
largest (~ 3%) in the world in term of value.
Growing at around 15-20% (6-8% in global) .
Expected grow and reach US$ 100 billion by 2025.
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6. Indian Pharmaceutical industry
More than 90% of drugs used in India are
produced in India
The industry is quite fragmented and comprises of
nearly 10,500 companies and majority of them in
the small sector.
Around 300-400 are organized companies
categorized as medium & large
Direct employment is 5lacs and total
employment could be over 20lacs
Mostly located in Maharashtra, Gujarat,
Telungana , AP, HP, Tamil nadu.
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7. * Among fastest growing Industries: The IPI (Indian
Pharmaceutical Industry) revenue is expected to
expand at a CAGR of 17.8 % during 2008-16 and reach
USD36 billion
* Rapid growing healthcare sector: By 2015, the
healthcare sector is expected to reach USD 100 billion
from the current USD65 billion.
* Growing Generic Market: The generic market is
expected to grow to USD26.1 Billion by 2016 from
current USD11.3 billion in 2011; India generics Market
has immense potential for growth
th
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8. Export Indian Pharma Industry
India competing with developed countries
due to lower manufacturing cost with better
Quality.
India import was huge and higher than the
export until late 1980s,
Since 1990 export starts growing , now
export is 5 times higher than import.
Export is 50% of the total turnover.
Exported to >200 countries for both
developed and developing countries.
Around 25% of export is to USA.
20% of the total volume of global generics
ie 1 in 5 of Generic * is from India.
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*Generic medicines, and to low-cost versions of newly-developed medicines

9. Highlights of Indian Pharma Industry
In 2001, CIPLA was in limelight, offered an AIDS drug to for
the price of $ 300 against $12,000 in US.
India manufactures 30% of the world requirement of Anti-
HIV drugs
key contributor to the WHO Prequalification Programme
(PQP) 65-70%
 AIDS, Tuberculosis, Malaria, Reproductive Health, and etc...
2012, NATCO got approval to sell kidney-cancer drug
Nexavar at 3% of market price under compulsory license.
 Cost Rs. 8500 against Rs. 2.8 lakh
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10. Advantage of Indian Pharma Industries
Global consumption of : The US accounts for 40-45%, EU is about 20-
24% and Japan 15%; balance is rest of world
So target market is US, EU & BRICS.
India is the highest USDMF approved country outside the US
India accounts for 30.3 per cent (2,911) of 9619 Drug Master Files
(DMFs) filed with USA, which is the highest outside of USA.
584 manufacturing sites approved by US FDA and next is Italy (< 200)
Several Indian Pharmaceutical companies set up plants in abroad
Fast growth in R&D activities.

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11. SS The effects in new product patent
SS Price control in the drugs
SS Reformation in the regulatory
SS Developments in the infrastructure
SS Quality Management concept
SS Conforming the global standards
The other challenges include:
* Decline in the production
* Reducer in Drug Approvals
* Stringent regulations02/25/16 11

12. :
Growth Potential: Opportunity
Indian Pharma industry posses several strengths;
Innovation and process design- to copy cat generic.
Strong R&D capability,
Qualified personnel
Abundant skilled man power
Around 270 large R & D based pharma companies in
India.
Past track is capable of producing better quality drugs
with lower manufacturing cost.
Knowledgeable and Skilled man power (Research,
analytical, regulatory, clinical and IT)
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13. Research & Development:
Indian Pharma companies spent huge amount for R&D.
Dr.Reddy’s, Sun Pharma, Gleanmark are investing in
discovery research
Several companies involved in process development and
contract research.
US $300 bn worth of Patent drugs expiries by 2017.
Global R&D cost is estimated as USD 65bn
Contract Research
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14. Top Indian Pharmaceutical companies
1. Sun Pharma
2. Dr. Reddy's Labs
3. Cipla
4. GSK
5. Strides
6. Lupin
7. Aurabindo
8. Wockhardt
9. Zydas Cadila
10. NATCO
11. Orchid
12. IPCA
13. Biocon
14. Torrent
15. Shasun
16. Alambic etc
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15. World Top Pharma Companies
Company Sales R&D Expense
1. Novartis $57,996 ($9946)
2. Pfizer $45,708 $8,393
3. Sanofi $41,047 $5,863
4. Roche $37,082 $9,006
5. Merck $36,042 $7,180
6. Johnson & Johnson $32,313 $6,213
7. GlaxoSmithKline $30,806 $5,693
8. AstraZeneca $26,095 $5,579
9. Gilead Sciences $24,890 $2,854
10. Teva $20,272 $1,488
Based on 2014 Sales, in $U.S. Millions
Ref : Contract pharma
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16. Money spent for healthcare
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17. 02/25/16 17
8 – 12 years
Drug Discovery is becoming more time and cost consuming…
Drug discovery process :

18. Clinical study:
A clinical trial is a tool for testing a drug,
medical device, or technique for safety
and efficacy.
Global clinical trial market is ~USD 60bn.
Money involved for new drug min is USD
600-mn 2bn out of this 150-200mn spent
for clinical trials
India will make it with 50-60% of cost
and faster.
The advantages are, technical resources
(physician, nurses, and other technical
personals), having developed IT
infrastructure, protection on IPR related
issues and etc.
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19. Job Opportunities
Pharma is knowledge based industry
Special skills are required to work
Offers excellent salary , benefits & scope for growth.
Job opportunities for Chemistry / pharmacy
graduates / pharmaceutical Technology/ Doctors
Government & private sector
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20. Job Opportunities
Government & Public sector:
State & Central Govt
Public sector
National Labs
Drug testing
Research & Development
 NIPER, CSIR, CDRL
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21. Job Opportunities in Pharma Industry
Functions/ Aactivities :
Marketing & Sales – Technical
Manufacturing/production
Environment management
Research & Development
Quality control & Quality assurance
Regulatory Affairs & IPR
Clinical trials
Testing laboratories- private
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22. Manufacturing/production:
Knowledge & Skill required:
Process Chemistry
Technology transfer
Chemical reaction
Handling of Chemicals
Unit operations
Reaction, distillation,
filtration, drying, blending
Formulation, etc
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23. Research & Development
Knowledge & Skill required:
Synthesis- all kind of organic
reaction
Process chemistry
Thermo chemistry
Kinetics
Structure elucidation
Patent search
New analytical techniques
Simple & easy test methods
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24. Quality Assurance & Regulatory
Quality Assurance & Regulatory functions
Pharma industries governed by stringent Rules &
regulations
Drugs & Cosmetic Act
Quality system
Good Manufacturing Practice (GMP)
Documents for each activities
Rules & Regulations as per exporting countries
Regulatory Inspection and approvals
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25. Testing /Quality Control
All kind of testing
Qualitative analysis
Quantitative analysis
Physico-chemical
properties
Spectroscopy
Chromatography
Instrument methods of
analysis02/25/16 25
Knowledge & Skill required for QC functions

26. Analytical technique
Chromatography
Spectrophotometry
Chiral testing- Optical rotation
Particle size
Dissolution
Inorganic impurity -Residue on
ignition
Crystal structure- XRD
Thermal properties - TGA/ DSC -
Melting point
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27. Simple instruments for testing
pH meter
Conductivity meter
Polarimeter
Refractometer
Titrator
Particle size
Dissolution apparatus
Etc…
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28. Spectroscopy
Theory, instrumentation and application
UV- Visible spectrophotometer
FT-IR Spectrum
Mass spectrophotometer
NMR
 AAS/ ICP-AES or OES
XRD
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29. Chromatography
Extensively used technique is
Chromatography for testing
of purity and impurity in
complex molecule;
TLC
Gas Chromatography
HPLC
Gel permeation
Ion chromatography
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30. Testing
Drugs are tested for :
Purity
Impurities
Structure confirmation –IR, UV
Specific rotation
Loss on drying/ water
Residue of Ignition (inorganic)
Dissolution
Drug release
Stability
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31. Regulatory Affairs
Technical writing
Rules & regulation of various countries
Basic chemistry
Basics of Process & testing
Computer knowledge & communication
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32. Preparedness
Over 15 years, employment potential could range
between 8-9 million jobs.
Education & training
Instrumentation course
Diploma in pharmaceutical course
Personal development
Interview skill
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33. Reference:
 Annual report 2014-15 & Chemicals & petrochemicals statistics AT A GLANCE:
2014 govt of india, ministry of chemicals & fertilizers
 INDIAN CHEMICAL INDUSTRY : Five year plan – 2012-2017
 The pharmaceutical industry and Global health facts and Figures 2014: IFPMA
 India Pharma summit 2014-15 position paper; dept of pharmaceuticals, govt of
india
 India Chem 2014 :Spurting the growth of Indian Chemical Industry: FICCI
 A Brief report of Indian pharmaceutical industry In India- ASA Associates
 India Pharma Inc. Gearing up for the next level of growth PWC
 From vision to decision Pharma 2020- PWC
 Profile of pharmaceutical industry- Chapter – iv
 Wikipedia
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