Contract Research in the Indian Pharmacutical Industry by xfu19942

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Pharmaceutical
          1
Gujarat: Economic Snapshot
Gujarat An Enduring Strong Economy

                                Gross State Domestic Product : USD 45.3 Billion Industrial Growth Rate : 12.5% (2002 – 2007)
                                Exports                        : 19.2% of India   Inflation                   : 9.3%
                                Per Capita Income              : USD 722          Urbanisation                : 37.36%


         Composition of GSDP as per Economic Activity                        Well Balanced Growth across sectors



                                                    18.22%                                Tertiary                                15.99%


                                          44%
                                                                                       Secondary                                   17.95%
           P r im a ry S e c t o r

           S e c o n d a ry S e c t o r
                                                      37.78%                              Primary                       11.36%
           T e r t ia r y S e c t o r
                                                                                          Source: Socio Economic Review 2007-08
 GSDP: Gross State Domestic Product



 Gujarat has exhibited a 12.5% high industrial growth rate from 2002 -2007. In India’s
 10th Five Year Plan and has achieved a GDP growth of 10.2% as per the set target,
  which was the highest amongst all States in India.




                                                                                                       Source: Socio Economic Review 2007-0 8
                                                                     2
 Robust Infrastructure
First State to privatize ports
       Ports
                          §   42 ports along 1600 km coastline, including 1 major port at Kandla and 41 minor ports
                          §   Cost efficient transportation of natural gas, crude oil and petroleum products from Middle East and Europe
                          §   Landmark projects such as LNG port terminal at Hazira developed by Shell India Limited, Green field port at
                          Mundra developed by Gujarat Adani Port Limited, LNG terminal at Dahej developed by Petronet LNG Ltd.
                          and Pipapav port developed by Gujarat Pipapav Port Ltd.




 Gujarat is well connected to major cities in the USA, EU, Asia and other Indian
 metropolitan cities                                                                                                       Airports

 §    13 airports under the operational jurisdiction of Airports Authority of India (AAI), at Vadodara, Surat, Jamnagar,
 Rajkot, Bhavnagar, Porbandar, Bhuj, Diu, Mandvi, Mundra, Kandla and Palanpur, including one international
 airport at Ahmedabad




     Rail & Road         71% of the road in the State is surfaced

                          § State-of-the-art road infrastructure such as India’s first National Expressway from Ahmedabad to Baroda.
                          § Total road length is 74, 111 Km
                          § Total length of railways in Gujarat is 5,188 km (8.25% of India)




                                                                         3
Robust Infrastructure
      Power            Electricity Generation Capacity – 9,561 MW (2007) and estimated to rise to
                       14,031 MW (2012)

                         § Per capita power consumption is 1,354 units whereas India’s average is 665 units
                         § Rich availability of natural gas (34 MMCD) and Lignite (1,072 MMT)
                         § 24-hour power supply to 98% of the villages


Total length of the existing GSPL pipeline is 1,453.16 km supplying to 18
districts                                                                                                            Gas

§ The pipelines of Gujarat State Petronet Limited (GSPL) supply gas to 13 districts, 5 more districts are proposed
to be connected by the pipeline
§ Total length of Integrated Gas Grid supplying gas to all districts is 2,200 km, of which 1,200 km is complete
and 800 km is under construction



       Water           Only State to carry out interlinking of rivers

                         § An extensive water grid network across the State
                         § The water grid is a network of 75,000 km for water distribution for irrigation
                         §   75% population proposed to be covered by the grid by 2010




                                                                       4
 Invest in Gujarat : A world- class Business Destination
                                                                                                 To Delhi


                                                                         Banaskantha


                                                                                                                        Bio-Tech Cluster
                                                                          Patan
                                                                                  Mehsana
  Soda Ash & Salt        Kutch                                                              Himmatnagar                Gujarat International
  Based Industries,                                                                Gandhinagar                          Finance Tec City
Cement & Steel Pipes                                                       Ahmedabad
                                                                                            Kheda        Panchmahal     Knowledge Corridor
                                                                 Surendranagar
                                                                                                               Dahod
202 Industrial Estates                                                            Anand                                  Industrial Corridor
   across Gujarat                                                                                                             (DMIC)
                                 Jamnagar
                                                                                            Vadodara                       Savli Biotech Park
                                               Rajkot
   Petroleum & Brass
          parts              Porbandar                                                              Narmada            Petroleum, Chemicals
                                                                                       Bharuch                          and Petrochemicals
 Engineering and                                                    Bhavnagar
                                                        Amreli                                                          Investment Region
    Ceramics                             Junagadh                                                                             (PCPIR)
                                                                                                 Surat


  Soda Ash and Salt                                                                                                    Chemicals, Petrochem.
       Based                                                                              Navsari                       Pharma, Textiles &
                                                                                                                           Engineering
                                                            Special Investment               Valsad
18 Captive Ports along
                                                              Region (SIR)                                                     51 Special
  1600 km coastline
                                                                                                                            Economic Zone
    across Gujarat
                                                                                                                             (SEZs) across
                                                                                          To Bombay                             Gujarat




                                                                     5
    Gujarat: A Thriving Industrial State
 Contributing to India’s economy across all major                                   Presence Across Industry Sectors
 sectors…
                Population       5%
       Geographical Area         6%                                                                                   Petroleum products         34%
                Employees         9.50%                                                                               Chemical & Pharma          23%
               Factorories        9.90%
                                                                                                                      Engineering                17.6%
                 Net Value            14%
                                                                                                                      Food processing            10.3%
           Value of Output            15.60%
  Fixed Capital Investment            17%
                                                                                                                      Textiles & Apparels        6.3%
                    Exports            19.20%                                                                         Mineral based industries   2.50%
        Longest Coastline               22%                                                                           Others                     6.30%
Stock market capitalisation                  30%
         Soda Ash Production                                                  98%
              Salt Processing                                           85%
         Diamond Processing                                            80%          …World’s largest producer of processed diamonds and wall
              Plastic Industry                                   65%
                                                                                    clocks
              Petrochemicals                                   58%
                  Chemicals                              50%
                                                                                    …World’s largest gas based single location sponge iron plant
                  Groundnut                         42.30%                          …World’s largest producer of castor and cumin
                       Cotton                     35%                               …World’s 3rd largest producer of denim
                                                        Significant share in
            Pharmaceuticals                  28%
                                                        key industry sectors        …Asia’s largest grass root petroleum refinery at Jamnagar
                  Sea Cargo                 25%
                                                        & products                  …India’s largest producer of cotton
                     Textiles          18%
                                                                                    …India’s first LNG Chemical Port Terminal at Hazira

  With 5% of population and 6% of Geographical
  Area contributes 16% of output                                                                                 Source: Socio Economic Review 2007-08




                                                                               6
 Global Pharmaceutical Industry
                       Global Pharmaceutical industry will touch USD 735 billion in 2008 registering a growth of 5-6%

 §     Much of the growth can be attributed to increasing incidence                                        Fig 1: World Pharmaceutical market – (2006 sales)


                                                                                                                     8.60%
       of lifestyle related diseases in the global population
                                                                                                                9.30%

 §     North America remains the largest pharmaceutical market with                                                                              47.70%



       49% share followed by Europe and Asia-Pacific
                                                                                                                  29.90%

 §     Global     pharmaceutical        market     is    witnessing     increased          North America (USA & Canada)             Europe
                                                                                           Japan                                    Africa, Asia (excluding Japan) & Australia
                                                                                           Latin America
                                                                                                                                             IMS MIDAS, MAT December 2006
       opportunities       in     the     area      of     Biopharmaceuticals,


       Pharmacogenomics and Biologics market


 §     Major players in global pharmaceutical market include Pfizer,


       Johnson and Johnson, Wyeth, Novartis, Merck & Co. ,


       GlaxoSmithKline, Astra Zeneca, Sanofi Aventis among others


Source: Extract from RNCOS World Pharmaceutical market 2007, IMS 2008 Global Pharmaceutical Market forecast




                                                                                    7
Indian Pharmaceutical Industry
                        Indian Pharmaceutical Industry ranks 4th in terms of volume and 13th in terms of value


                                                                                                         Fig 2: Indian Pharmaceuticals Growth Trend
§      In value terms, Indian pharmaceutical industry is over USD 6 billion
                                                                                                    14                                                Estimate
§     The industry holds 8% share in global volume sales and 1% share                               12
                                                                                                                                           CAGR




                                                                                   Value (USD Bn)
                                                                                                    10                                     16%
                                                                                                    8
      in global value sales                                                                                             CAGR
                                                                                                    6                   13%

                                                                                                    4
§     Indian pharmaceutical companies meet almost 70% of country’s                                  2
                                                                                                    0
      demand for bulk drugs                                                                                   2001-02            2006-07              2011-12


                                                                                                              Indian Companies – Global Forays
§     India is among the top five API producers and world’s third largest
                                                                                                                               Japan
                                                                                                     Zydus Cadila                            Nippon Universal
      manufacturing industry
                                                                                                                          South Africa          Be-tabs
                                                                                                         Ranbaxy
§     Foreign direct investment into country’s pharma industry is over                                                                       Pharmaceuticals

                                                                                                          Jubilant             USA                   Forest
      USD 170 million                                                                                    Organosys                                Laboratories

                                                                                                                               Paris                Negma
                                                                                                    Wockhardt Ltd.
                                                                                                                                                  Laboratories


    Indian Pharmaceutical Industry has grown at a CAGR of 13% from 2002-2007 and is expected to grow at a CAGR of 16% over
                                                           2007-2011
Source: KPMG Pharma summit 2007, IBEF Pharma report




                                                                      8
Indian Pharmaceutical Updates

                      ALEMBIC                            Reliance Life Sciences
      § Alembic, the oldest pharmaceutical            § Reliance Life Sciences plans to set up
      company in the country, plans to set up         an API and pharmaceutical ingredients &
      its own SEZ                                     formulations manufacturing complex at
      § The proposed SEZ is located at Kavi           Jamnagar
      and Nahar village on the Mahisagar              § The complex will come up in the multi-
      tidal sanctuary                                 product SEZ




        Veeda Clinical Research                        Dr. Reddy’s Laboratories
      § Veeda Clinical Research, a full service
                                                      § DRL bought Jet Generici Sri, an Italian
      global CRO launches global oncology
                                                      generics company
      CRO to provide oncology clinical
                                                      § The company entered into a drug
      Research services internationally to
                                                      discovery collaboration with 7TM Pharma
      pharma and biotech companies



Source: Company websites, News articles




                                                  9
Gujarat Pharmaceuticals: The center of Gravity
§       Gujarat is known as the hub of Indian pharmaceutical

        industry with around 3,245 manufacturing licensees                            Facts                                        Value Proposition

§       The State manufactures and exports different dosage                       • 3245 Manufacturing licensees              • Cost-competitive research base
                                                                                  • 42% of India’s pharma turnover            • Large & skilled workforce
        forms including tablets, capsules, dry syrup, external                    • 22% of India’s pharma exports             • Skills in process chemistry
        preparations, cytotoxic drugs, sex hormone drugs,                         • Employs 52,000 people                     • Globally harmonised regulations
                                                                                  • Large domestic market
                                                                                                                              • Presence of pharma clusters and
        vaccines, small & large volume parental, APIs, biopharma                  • FDA approved plants
                                                                                                                                Special Economic Zones
        products and many others

§       The State houses several established domestic as well
                                                                                                                        Gujarat
        as multinational players like Zydus Cadila, Sun, Sanofi                                                      Pharmaceutical
                                                                                                                       Industry
        Aventis, Wyeth among others
                                                                                      Enablers                                          Regulatory
§       Gujarat is home to approximately 40% of Contract
                                                                                  • Established Chemical Industry             • Product Patent Regime
        Research Organisations (CRO) in the country. CRO                          • Backward linkages                         • World      Health    Organisation
                                                                                  • Well developed medical equipment            (WHO) compliant manufacturing
        players like Lambda therapeutics, Synchron, Clinsearch,
                                                                                      industry                                  units
        B.A. research, VEEDA research are present in the State                    • Well developed IT capabilities            • cGMP         compliance          of
                                                                                  • Well developed Pharma Machinery             International standards
§       Various prestigious educational and research institutes                       Industry & Pharma packaging
                                                                                                                              • Government                supported
        like L.M. college of pharmacy, NIPER, B.V.Patel PERD                      • Large number of CROs
                                                                                                                                incentives and subsidies
                                                                                  • Academic & Research institutes
        institute have their presence in the State
    Source: KPMG Pharma Summit 2007, E&Y database, FDCA, Government of Gujarat




                                                                                 10
Gujarat Pharmaceuticals: Some key features
                        Gujarat State is the manufacturer of maximum number of dosages within the country




Gujarat is the only State in the country to issue sales license through I.T. application with the help of National Informatics Center




           Gujarat State is home to major Ayurvedic medicine players like Zandu, Paras, Ban Pharma, Vasu and others




                   J B Chemicals and Pharmaceuticals sells its ayurvedic cough syrup to Russia as a monopoly




    Gujarat State has its presence in Homeopathic medicines with turnover of around INR 15 crore and availability of 7500
                        practitioners, 216 government dispensaries and 15 (UG and PG course) colleges




  Sintex International – homeopathic player has introduced Household Medicine kit for common ailments – 1st time in country




Source: FDCA, Government of Gujarat




                                                                     11
Gujarat Pharmaceuticals: Some key features

        Gujarat State is the only manufacturer of a more stable and effective digestive enzyme – Pink papain in the world




Gujarat State is the only manufacturer in the country of Ranitidine hydrochloride with 5 years shelf life with minimum impurities.
                                                 It is exported to US and Europe




                     Gujarat State manufactures 90% of Intra Venous (I.V.) sets manufactured within the country




                                      Gujarat State holds 45% market share in Intraocular lens segment




      Gujarat is known for highest voluntary blood donations within the country with presence of around 177 blood banks




         Gujarat is safe from the menace of spurious drugs and hence it has better acceptance among medical fraternity




Source: FDCA, Government of Gujarat




                                                                        12
Location Analysis
    Ahmedabad cluster                            Pharmaceutical Clusters in Gujarat
                                                                                                 Vadodara cluster
    Manufacturing Base:                                                                          Manufacturing Base:
    ü APIs
                                                                                                 ü Finished Dosages
    ü Finished dosages
                                                                                                 ü Biogenerics
    ü Biologicals
    ü Contract manufacturing




    Ankleshwar cluster
    Manufacturing Base:
    ü APIs
    ü Formulations
    ü Vaccines
                                                                                      Bharuch and Vapi/Valsad cluster
                                                                                      Manufacturing Base:
                                                                                      ü Finished Dosages
                                                                                      ü APIs
Source: KPMG report on Gujarat Pharma Industry




                                                                    13
Key Current Statistics
                      Fig 3: Manufacturing licensees in Gujarat (2006-07)
                                         14
                                                                                § Highest number of Schedule M compliant manufacturing units
                              574
                                                                                § 327 license holders with WHO GMP certification
                                                                                § 38+ units with International certification
                                                              Allopathic
                                                                                § 100+ New Drug Applications (NDA) filed by various companies
                                                              Ayurvedic
                                                                                § 60+ pharmacy colleges in Gujarat
                                                              Hom eopathic
                                                                                § Gujarat – Export hub in India with exports to 200+ countries
                                                                                § Gujarat – R & D hub with presence of world class centers of companies like
                                                                                     Sun, Torrent, Intas, Zydus
                                                  2657



                                                       Gujarat has around 23,835 wholesalers and retailers base

     Fig 4: Gujarat Sales Break up as per MAT June ’07 (at retail prices)                                                Fig 5: Gujarat Exports of Pharmaceuticals in value terms


                     700                                                                                                 60                                             56.00
                                                                              606
                     600                                                                                                 50




                                                                                                 Exports (INR billion)
 Sales (INR Crore)




                     500                                                                                                                                      36.55
                                                                 403                                                     40
                     400                                                                                                                     29.82
                                                                                                                         30
                     300
                                                                                                                         20
                     200                        146                                                                             11.75
                               104
                                                                                                                         10
                     100

                       0                                                                                                 0
                             Vadodara          Surat          Ahmedabad       Rest                                             2003-04      2004-05          2005-06   2006-07
                                                                                                                                                      Year




                                                                                         14
Value Chain Analysis
              Research and Development             Clinical                             Manufacturing
                                                                                                                                   Sales
                                                 Development                                                                         &
 Design of   Research     Pre-clinical
                                            Clinical
                                                          Phase IV               API                                              Marketing
                                          Development                                            Formulation   Packaging
 Molecule    Biology      Development                      trials           manufacturing
                                         Phase I/II/III




                                                                          § Nirma Institute of Pharmacy
                        Education / Research                              § C U Shah college of Pharmacy and research
                             Institutes                                   § S R Patel college of Pharma education and research
                                                                          § B K Modi government pharmacy college
                             Research
                                 &
                            Development                                   § Zydus Cadila Healthcare Ltd.       § Torrent Pharmaceuticals Ltd.

                                                                          § Claris Life sciences Ltd.          § Dishman Pharmaceuticals

                           Manufacturing                                  § Cadila Pharmaceuticals Ltd.        § Abott Laboratories

                                                                          § Intas Pharmaceutical Ltd.          § Wyeth

                                                                          § Sun Pharma                         § Jubilant Organosys
                        Marketing and Exports


                                                                          § Lambda Therapeutics
                                                                          § Quintiles
                 Contract Research Organisations
                                                                          § Synchron
                                                                          § B A Research




                                                                     15
Emerging Areas
                 § Offers high quality & specialized healthcare services and infrastructure at low costs
   Medical       § Availability of highly qualified specialists in the areas of Ophthalmology, Urology, Embryology, Orthodontics,
   Tourism         Oncology and Orthopedics
                 § Linkages with organisations / NGOs in overseas countries to acquire knowledge

                 § WHO GMP complaint and internationally accredited manufacturing facilities to augment demand for contract
   Contract        manufacturing
 Manufacturing
                 § Local domestic industry has strong presence across entire value chain

                 § The enactment of product patent regime to further increase the confidence of global companies


                 § Gujarat houses approximately 40% of Contract Research Organisations in the country
   Contract      § Enhanced level of investment in R&D by local industry to provide research-driven and high value services
   Research      § Emerging service areas include lead identification, clinical and pre clinical research, bioinformatics, clinical data
                   management and Bio equivalence studies


                 § Medical device industry in Gujarat is growing with current industry size of more than INR 100 crore
                 § The State has presence of around 60 units manufacturing medical devices with 15 units having GMP certification,
                   22 units having ISO certification and 7 units having CE certification for exports to Europe
   Medical
                 § Gujarat State meets 80-85% of country’s requirement of Intra venous (I.V.) sets and Blood Transfusion (B.T.)
   Devices
                   tubes and catheters
                 § The basic RM (plastic granules) required for medical device is available in the State manufactured by Reliance
                   Industries Limited and IPCL




                                                            16
Emerging Areas
                  § The State government has declared Biotechnology as strategic priority sector

 Biotechnology    § Biopharmaceuticals constitute around 60% of total Biotechnology sector of the State
   Products       § Leading pharma majors like Zydus, Torrent, Sun, Intas & others have made foray into biotechnology with niche

                    products


                  § Gujarat is rapidly gaining ground as the preferred destination for off shoring clinical research activities

                  § Opportunities exist primarily in Phase II to IV trials and BA/BE studies for generic drugs by pharmaceutical
    Clinical
                    companies across the globe
   Research
                  § Gujarat provides a large pool of patients and hospitals conducting clinical research at economical cost

                  § Major transnational CRO Quintiles has established its presence within Ahmedabad in the State


                  § Immense untapped potential for organised retail in pharmaceutical sector in the State
 Pharmaceutical   § Prominent pharmacy chains present in the district include Apollo pharmacy (Apollo group), Subhiksha,
    Retailing
                    Dialforhealth (Zydus group) and Himalaya herbal medicines


                  § Strong opportunity for manufacturing of pharmaceutical machinery in Gujarat
 Pharmaceutical   § Nearly 40-50% of the country’s requirement for pharmaceutical machinery is manufactured in Gujarat
   Machinery
                  § Presence of players like Ambica Engineering, Karnavati Engineering and Cadmach involved in manufacturing

                    various types of machinery used in pharmaceutical production




                                                              17
 Industrial Strengths

Proactive and Educative                                  Established                                      Technically competent
 approach of Food and                                       Allied                                        and cooperative staff at
Drugs Control                                                                                             Food and Drugs Control
Administration                   Large domestic         Industry base                                     Administration (FDCA)
(FDCA)
                                   market and
                                    growing                                           Established
                                    exports                                          Manufacturing
                                                                                     Infrastructure

                                                        Pharmaceutical
                                                           Industry
                          Cost advantage                  Strengths
                          especially in
                                                                                        Key Research
                          Raw Materials
                                                                                       & Development
                                                                                           Clusters


                                           Large base
                                                                                                       FDCA undertakes
                                           of skilled                Education and
FDCA practices least                                                                                   cGMP interactions
 control-best control                      Manpower                   Research                          with new players
policy while implementing                                                                              before issuing the
 strict rules for license                                             Institutes                        license to sensitize them
 issuance                                                                                               about the requirements




                                                                 18
Special Economic Zones
   PHARMEZ (Zydus Cadila)

   Location: Ahmedabad

   Area: 49 hectare

   Likely activities: NA
                                      PHAEZ (Cadila Pharma)
                                      Location: Ahmedabad
                                      Area: 200 hectare
                                      Likely activities: Biologicals,
                                                                             Ahmedabad
   Jubilant PHARMA SEZ                APIs & Pharmaceuticals
   Location: Bharuch
   Area: 200 hectare
   Likely activities: Manufacturing
   hub for pharmaceuticals, fine &                                               Bharuch
   specialty chemicals outsourcing    Dishman PHARMA SEZ

                                      Location: Ahmedabad

                                      Area:139 hectare

   J B Chemicals SEZ                  Likely Activities: Bulk drugs
   Location: Bharuch
   Area: 130 hectare
   Likely activities: Bulk drugs,
   Intermediates, R & D and
   Contract manufacturing




                                                                        19
Investment Opportunities
                                        Manufacturing

                           Contract Manufacturing Organisation (CMO)

                         Manufacturing of New Dosage forms like Patches

                      Manufacturing of recombinant and DNA based products

                        Manufacturing of Intermediates and fine chemicals

                                Manufacturing of medical devices

                            Manufacturing of Ayurvedic preparations
        Destination

        Gujarat         Manufacturing of Active Pharmaceutical Ingredient

                              Manufacturing of Oncology products

                              Manufacturing of Biopharmaceuticals



                                 Research & Development

                             Contract Research Organisation (CRO)

                                        Clinical research

                                    Setting of R & D centers




                                     20
Leading Industry Players



                                Ahmedabad




                                      Vadodara




                           21
Leading Industry Players
Company   Business Description                                                                         Manufacturing Facility Approved by
                                                                                                       International Agencies
          § Key Business Areas - Finished formulations and APIs                                        cGMP (EU), BFDA (Taiwan), MHRA (UK), BfArM
          § Key Therapeutic Areas - Cardiovascular, Central Nervous System, Gastro-Intestinal,         (Germany), TGA (Australia), MCC (South Africa),
            Diabetology, Anti infective and Pain management                                            ANVISA (Brazil), MoH (Latvia), NDA (Uganda),
          § Key Research Areas - Discovery research, Generic drug development, New Drug                MCAZ (Zimbabwe), Anvima (Columbia), National
            Delivery System and Value added generics                                                   Institute of Pharmacy (Hungary)

          § Key Business Areas - APIs, Fine chemicals, Formulations, Animal Health and                 USFDA, AFSSAPA (France), MHRA (UK) for Solid
            Cosmeceuticals                                                                             Orals, MCC (South Africa), ANVISA (Brazil), PIC
          § Key Therapeutic Areas - CVS, CNS, Women health, Respiratory, Pain
                                                                                                       (Romania), BFAD (Philippines), NDA (Uganda),
            management, Anti infective, Oncology, Nephrology, Neuroscience and Dermatology
                                                                                                       MoH (Latvia, Ghana, Romania and Namibia)
          § Key Research Areas – New molecular entities, Novel drug delivery system,
            Identification & Validation of therapeutic targets, Therapeutic proteins and vaccines by
            r-DNA technology

          § Key Business Areas - Formulations (Human & Veterinary), APIs, Hospital products            USFDA, MCA (UK), MCC (South Africa), TGA
          § Key Therapeutic Areas - CVS, Gastro intestinal, Analgesic, Anti-infective,                 (Australia)
            Antidiabetic, Vitamins, Haemostatic, Immunomodulators
          § Key Research Areas - New Drug Discovery, New Drug Delivery, Plant tissue culture,
            Genetic engineering, Biosynthesis, Phytochemistry

          § Key Business Areas - APIs, Finished formulations                                           USFDA, MHRA (UK), MCC (South Africa), ANVISA
          § Key Therapeutic Areas - CVS, CNS, Diabetology, Gastroenterology, Pain                      (Brazil), INVIMA (Columbia)
            management, Anti allergic
          § Key Research Areas - Generics, Process Development and Complex generics




                                                                         22
Leading Industry Players
Company   Business Description                                                                      Finished Dosage Manufacturing
                                                                                                    Facility Approvals
          § Key Business Areas - APIs, Formulations, Contract research                              USFDA, MHRA (UK), TGA (Australia), ANVISA
          § Key Therapeutic Areas - CNS, CVS, Diabetology, Gastroenterology, Urology and            (Brazil), MCC (South Africa)
            Pain management
          § Key Research Areas - NDDS for formulations, API capabilities for Anti cancer
            agents, oral formulations, NDDS and drug delivery mechanisms

          § Key Business Areas - APIs, Chemicals, Formulations, Herbal Nutraceuticals and           USFDA, MHRA (UK), MCC (South Africa), EDQM
            Veterinary                                                                              (European Union)
          § Key   Therapeutic    Areas -     CVS,    Gynecological,   Gastrointestinal,   NSAIDS,
            Antibacterial, Antihistamine, Hypoglycemic, Vitamins, Antiulcerant
          § Key Research Areas - Chemistry and Synthesis, Formulations Development,
            Contract/Collaborated Research

          § Key Business Areas - APIs, Intermediates, Fine chemicals, Quaternary compounds          MHRA (UK), EDQM (European Union), COS
          § Specialised services - Contract manufacturing and Contract Research                     (European Union) for APIs
          § Key Research Areas - Research for contract manufactured products, pilot studies of
            new molecules, Process optimisation and improvement, Research for in-house
            applications (APIs, Intermediates, Fine chemicals)




                                                                        23
Key Alliances of Gujarat Based Companies
   Sun Pharmaceuticals                                           Israel based Company                                    Taro Pharma
                                                           For Generic penetration in US market



                                                                     Brazilian Company
                                                                                                                            Nikkho
                                                      For entry into Branded generics market in Brazil

                                                                      Japanese Company
                                           For critical access to ready manufacturing and marketing base in Japan      Nippon Universal
       Zydus Cadila

                                                                   US based Company
                                          For development of therapeutic protein – PEG-EPO for anaemia treatment    Prolong Pharmaceuticals

                                                                   Sweden Company
                                          For discovery & development of novel glucocorticoid receptor modulators          Karo Bio



                                                                   Japanese Company
  Lupin Pharmaceuticals                                   For Generic penetration in Japan market                           Kyowa




                                                                  Belgium based Company                                      UCB
          Alembic                                         Out-licensing deal for Anti-Epileptic drug



                                                               Switzerland based Company                                   Novartis
 Torrent Pharmaceuticals                          R & D licensing deal for Age Breaker Diabetic molecule

Source: Company websites, News articles




                                                                                  24
    Sanofi-Aventis: Presence in Gujarat
§      Sanofi-aventis is the world’s third largest pharmaceutical group and the
                                                                                                   Product Portfolio
       largest in Europe                                                                 Pharmaceuticals and Chemistry
§      The company has a manufacturing unit present in Gujarat, at Ankleshwar         ü Avil
§      The Chemistry plant was set up in 1987 and Pharmaceutical plant was set        ü Allegra

       up in year 1989                                                                ü Lasix

§      It is a multi-technology plant which has facilities to produce both uncoated
                                                                                      ü Novalgin

                                                                                      ü Combiflam
       and coated tablets
                                                                                      ü Rifampicin
§      The Chemistry plant has been recently accredited by the US FDA and will
                                                                                      ü Tarivid
       supply API – Glibenclamide
                                                                                      ü Tavanic
§      Apart from pharmaceuticals, the plant also manufactures intermediates and      ü Trental
       API for sourcing                                                               ü Pheniramine Maleate
                          Manufacturing Plant - Ankleshwar                            ü Articane HCL
    Total Floor Area                                           12,600 m2              ü Glibenclamide
    Dosage Form                                                  Solids               ü Lasamide
    Current Capacity (per annum)                         3,700 million tablets        ü Ramipril Intermediates

Source: Company website




                                                                           25
Educational Infrastructure
Districtwise Presence of Various Pharmaceutical Educational Institutions



                                                                                    Sabarkantha
                                                                      Mehsana

                 Kutch
                                                                        Gandhinagar

                                                                Ahmedabad

                                                Surendranagar


                                                                            Anand

                              Rajkot                                                      Vadodara


                                                       Bhavnagar

                                       Amreli


                                                                                     Surat




                                                                                      Valsad




                                                           26
Educational Infrastructure
   Gujarat boasts of one of the oldest pharmacy college – L.M. college of pharmacy established in 1947 providing Diploma,
                                          Bachelor and Master in Pharmacy courses



        Diploma in Pharmacy                          Bachelor in Pharmacy                          Master in Pharmacy

B.K. Modi Govt. Pharmacy                     A.P.M.C college of Pharmaceutical            Anand Pharmacy college
                                             Education and Research
Dr. Dayaram Patel Pharmacy college                                                        A.R.college of Pharmacy & G.H. Patel
                                             Anand Pharmacy college                       Institute of Pharmacy
B.M. Shah college of Pharmacy
                                             The Maharaja Sayajirao University of         Dayalbhai R. Patel Institute of PG
Tolani Institute of Pharmacy                 Baroda                                       studies
M. N. college of Pharmacy                    L.M. college of Pharmacy                     K.B. Institute of Pharmacy Education &
Shantilal Shah Pharmacy college                                                           Research
                                             Nirma Institute of Pharmacy
R.D. Gardi Govt. Diploma pharmacy                                                         The Maharaja Sayajirao University of
                                             C.K. Pithawala Institute of
                                                                                          Baroda
Sanskar Kelavani Trust’s college of          Pharmaceutical Science & Research
Pharmacy                                                                                  Shree S.K. Patel college of
                                             C.U. Shah college of Pharmacy and
                                                                                          Pharmaceutical Education & Research
                                             Research
Sardar Vidya Bhavan Trust’s college
                                                                                          Nirma Institute of Pharmacy
                                             L.J. Institute of Pharmacy
                                             K.B. Institute of Pharmacy Education
                                             and Research
                                             Sigma Institute of Pharmacy
                                             Shree S.K. Patel college of
                                             Pharmaceutical Education & Research
                                             Shri B.M. Shah college of Pharmacy
                                             A.R. college of Pharmacy & G.H. Patel
                                             Institute of Pharmacy




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Research Institutes
                 B.V.Patel Pharmaceutical Education and                            National Institute of Pharmaceutical Education and
                  Research Development (PERD) Center                                                Research (NIPER)

ü       An internationally recognized research institute
                                                                           ü    The Government of India has declared NIPER as an
ü       India’s first multidisciplinary, postgraduate research institute
                                                                                ‘Institute of National Importance’
        dedicated to the pursuit of excellence in the pharmaceutical
        sciences                                                           ü    First national level institute in pharmaceutical sciences with

       Research                                                                 an objective of becoming center of excellence for advanced

    Biostatistics & Computers, Microbiology, Synthetic & Medicinal              studies and research in pharmaceutical sciences
    Chemistry, Pharmacology & Toxicology, Pharmacognosy &
                                                                           ü    Set up in Ahmedabad district having the course of MS in
    Phytochemistry, Biotechnology, Pharmacokinetics, Pharmaceutics

                                                                                pharmacy with an intake capacity of 31 students
        Services


    Formulation development, BA/BE studies, Clinical facilities,
    Toxicity studies, Clinical trials, Quality assurance, Stability
    studies, Technical consultancy


       Education


    Ph.D. program, Continuing education, International Symposia




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Government Support
                               § The State has allowed setting up of Special Economic Zones in the sector
                                 which will boost the pharmaceutical investments

                                      § I.T. application for issuance of manufacturing license and product
                                        license is under development by FDCA

                                               § For quick disposal of various documents like CoPP, NCC and FSC,
                                                 FDCA has initiated the process of I.T. application for such documents
                                                 which will be implemented soon


                                                     § Promotion of generic drugs by keeping them outside price control and by
         Government                                    giving them preference in Government purchases
          Initiatives
                                                      § Establishment of National Institute for Pharmaceutical Education and
                                                        Research (NIPER) for Human resource development

                                                § Presence of Pharmaceutical Export Promotion Council (Pharmexcil),
                                                Indian Drug Manufacturer’s Association (IDMA), State Pharmacy Council
                                                and Food and Drug Control Agency (FDCA) to support the industry

                                        § Introduction of Pharmaceutical Technology Upgradation Fund Scheme of
                                          51% Interest subsidy for implementation of Schedule M of Drugs and
                                          Cosmetics Rules for Good Manufacturing Practices

                                § Incentives to encourage Research and Development in the sector in terms
                                  of various tax benefits

 Source: Draft Pharmaceutical Policy 2006, FDCA, Government of Gujarat




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Key Contacts

  Food and Drug Control Administration, Gujarat        http://gujhealth.gov.in/FDCA/

  Indian Drug Manufacturers Association                http://www.idma-assn.org/

  Industries Commissionerate, Government of Gujarat    http:// www.ic.gujarat.gov.in

  iNDEXTb – Industrial Extension Bureau                http://www.indextb.com

  Gujarat Industrial Development Corporation           http://www.gidc.gov.in


  Gujarat Infrastructure Development Board             http://www.gidb.org




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     Knowledge Partner

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