-Dr. A. Amsavel

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Content

Indian Chemical Industries Indian Pharmaceutical Industries-An over view.

Opportunities

Knowledge & Skills

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Indian Chemical IndustryIndian Chemical Industry plays a major role in the overall

development of IndiaContributes significantly to India’s economy under

manufacturing sectorIt accounts for approximately 7% of India’s GDP.Output value in the year 2012-13 was 782,949 croresIndian 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$ 46.01Chemical industry growth rate of over 8-11% p.a. and

expected to reach $290 billion by 2017

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Chemical industries- CategoryThe chemical industries broadly categorised;

Basic inorganic & Organic chemicals Specialty chemicals & fine chemicals Petrochemicals & plastics, Pesticides & Agrochemicals, Fertilizers Dyes & pigmentsPaints & varnishes, Soaps, perfumes & toiletries and Pharmaceuticals and others

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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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Indian Pharmaceutical industryMore than 90% of drugs used in India are

produced in IndiaThe 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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* 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

* Ranked 5th in terms of attracting FDI: Attracted 5% of the total FDIs into India from April 2000 to March 2013.

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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.

05/03/23 8*Generic medicines, and to low-cost versions of newly-developed medicines

Highlights of Indian Pharma IndustryIn 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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Advantage of Indian Pharma IndustriesGlobal consumption of : The US accounts for 40-45%, EU is about 20-

24% and Japan 15%; balance is rest of worldSo 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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SS The effects in new product patentSS Price control in the drugsSS Reformation in the regulatorySS Developments in the infrastructureSS Quality Management conceptSS Conforming the global standardsThe other challenges include:* Decline in the production* Reducer in Drug Approvals* Stringent regulations* Government regulations in price controls* High Development costs* Expensive research and development practices

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:

Growth Potential: OpportunityIndian Pharma industry posses several strengths;

Innovation and process design- to copy cat generic. Strong R&D capability, Qualified personnelAbundant 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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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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Top Indian Pharmaceutical companies1. 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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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. MillionsRef : Contract pharma

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Money spent for healthcare

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8 – 12 years

Drug Discovery is becoming more time and cost consuming…

Drug discovery process :

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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Job OpportunitiesPharma 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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Job OpportunitiesGovernment & Public sector:

State & Central GovtPublic sectorNational LabsDrug testingResearch & Development

NIPER, CSIR, CDRL

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Job Opportunities in Pharma IndustryFunctions/ Aactivities :Marketing & Sales – Technical Manufacturing/production Environment managementResearch & Development Quality control & Quality assuranceRegulatory Affairs & IPR Clinical trialsTesting laboratories- private

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Manufacturing/production:

Knowledge & Skill required:

Process ChemistryTechnology transfer Chemical reactionHandling of ChemicalsUnit operations

Reaction, distillation, filtration, drying, blending Formulation, etc

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Research & Development Knowledge & Skill required:Synthesis- all kind of organic

reactionProcess chemistryThermo chemistryKineticsStructure elucidationPatent searchNew analytical techniquesSimple & easy test methods

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Quality Assurance & RegulatoryQuality Assurance & Regulatory functionsPharma industries governed by stringent Rules &

regulationsDrugs & Cosmetic ActQuality systemGood Manufacturing Practice (GMP)Documents for each activitiesRules & Regulations as per exporting countriesRegulatory Inspection and approvals

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Testing /Quality Control

All kind of testingQualitative analysisQuantitative analysisPhysico-chemical propertiesSpectroscopyChromatographyInstrument methods of

analysis

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Knowledge & Skill required for QC functions

Analytical techniqueChromatographySpectrophotometry

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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Simple instruments for testingpH meter Conductivity meterPolarimeterRefractometer TitratorParticle sizeDissolution apparatus Etc…

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SpectroscopyTheory, instrumentation and applicationUV- Visible spectrophotometerFT-IR SpectrumMass spectrophotometerNMR AAS/ ICP-AES or OESXRD

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Chromatography Extensively used technique is

Chromatography for testing of purity and impurity in complex molecule;

TLC Gas ChromatographyHPLCGel permeation Ion chromatography

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TestingDrugs are tested for :

Purity ImpuritiesStructure confirmation –IR, UVSpecific rotationLoss on drying/ waterResidue of Ignition (inorganic)DissolutionDrug releaseStability

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Regulatory Affairs

Technical writingRules & regulation of various countriesBasic chemistry Basics of Process & testingComputer knowledge & communication

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PreparednessOver 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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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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