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M!nlswy or Com.merc:e & InduSlJ1l, UOvE!r"-nment of Indlifl

Pharmaceuticals Export Promotion Council (Set up by Ministry of comrneree & Industry, Government ct India)

INDIA - THE EMERGING HUB FOR HIGH QUALITY AFFORDABLE GENERICS

Introduction

The domestic pharmaceutical market size of India (at retail value excluding public procurement and exports), stood at approx, US$12.Zbn against US$n.08bn in 2007-08 growing by a healthy 10% year on year.

Indian pharmaceutical industry is:

• 4'" in the world in terms of production volume

• 13'" in domestic consumption value

• 17'" in terms of export value of bulk actives and dosage forms

• The country accounts for 8% of global production and

• 2%ofwor'ld pharmaceuticals markets

The exports of Drugs, pharmaceuticals & fine chemicals stood at US$8.6Ibn during the year 2008-·09(refer chart 1). The exports grew at a compounded annual, growth rate (CAGR) of 21.98% during the five year period from 2004·05 to 2008·09.

Broadly, Asi.a is the largest impcrtlng region with a share of 30% of India's pharmaceutical exports followed by Europe (Z4%) and North America (21%), Africa (16%) and LAC (8%) (refer chartZ)

During 2008-09 United States of Amerka is the top export destination valued at US$1.55bn with a share of approx, 18% in India's pharmaceutical exports followed by Russia (US$0.33bn with a share of 3 .84%), Germany I US$0.31bn, 3.65%), Austr:ia

(US$0.31bn, 3.58%) and UK (US$O.27bn, 3. 12%). ~:;.~',t .. :::;::;:,',,:","~::';';:~:(:,~

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India is a globally acknowledged source of high quality affordable generic medicine with rich vendor base. India is not only an API and formulation manufacturing base, the country is poised to become manufacturing hub for pharmaceutical mdustrv of the world and an emerging hub for Contract research, Bio-technology, Clinical trials and Clinical data management. The country's pharrnaceutlcal 'industry has shown tremendous progress in terms of infrastructure development, technology base creation and a wide range of production covering almost all therapeutic categories and: do s age form s As per Pr:icewaterhouseCoopers report, finished: generics supplied from India account for 20% of the global generics market. It is est i mated that 70% of th e pati e nt S bel on gin g to 87 d evel op in g cou ntries received medicine procured: from India by the United Nations Children's Fund (U N ICEFj,lnternational Dispensary Association (I DA), the Global Fund and the Clinton Foundation. The country has appro x, 1,000 WHO CGMP approved pharmaceutical plants. It has 153 European Directorate of Quality Medicine (EDOM) approved manufacturing facilities among which 32 sites have CEP approval's (Sep. 2008) (refer table 1).

India has 1,735 (2,101) Tvpe-ll active DMF filings with US FDA of all 6,482 DMFs filed which IS 26.76% as On Sep. 2008 (refer chart 5).

As per WHO data and Pharmexcil research more than 90% of API approvals for ARVs, Anti·tubercular & Anti-malarials (WHO '-",-, -.,-_-- .. -,-""'--,"-_-_-,, ,--::"""-::c._:--:-:.'"':-c::~_-,-.c-: •• c: .. c:"'::--,

Prequalifled] are granted to India. Of the total of 4,942 prequallfted ......... ''';:,_~- ... '''l

approvals granted by WHO as on Jan, 2009 to 12 countries, India has 3'" highest number of approvals (621) for 6 companies. It also has the highest number of approvals from PEPFAR

Composition of India Pharmaceutical Exports

I n the year 2008-09, approx, 58% of India's pharmaceutical exports comprised followed by Bulk Drugs 41% and herbals exports a share of 1% (refer chart 3 & 4).

India's Strength in Generic pharmaceuticals

India's Cost Advantage

India has high cost advantage in manufacturing, R&D & clinical trials. The cost of manufacturing in India is estimated to be half of that of western countries and cost of conducting clinical trials are less, than 40% to that of western countries - Chart 6 below.

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Strengths of Indian Pharmaceutical Industry

1. Today, India offers skllled scienti,ts/techniclans/management personnel at affordable cost. Low cost of

innovation / manufacturing/capax costs/ expenditure to run a cGMP complaint facility,

2. The scientific, technical and manufacturing skills, developed under the country's 3S-year process patent system, perfectly matches the requirements of global drug manufacturers who are increasingly seeking to many manufacturing activities previously performed in-house,

3, The country has well developed chemistry R&D and manufacturing infrastructure with proven track record in advanced chemistry capahilltias, design of high tech manufacturing facilities and regulatory compliance.

4. It is known for its competency in API/Formulation Intellectual Property creation, facility design and maintenance, global regulatorv affairs, legal acumen and managing international work force,

S. India not only for its traditional strengths in contract manufacturing but also as a high;ly attractive location for research and development (R&D), particularly in the conduct of clinical trials and other services such as

formulation development, bioequivalence testing, stability studies centers, etc,

6. India. has quite a number of resourceful firms in the field of Chemistry providing high quality output In timely schedules, allowing more leads to pursue.

7. India is significantly ahead in chemistry services such as analog preparation, analytical chemistry, focus library, cornbsnatorta I chemistry, strurtu ral chemistry, structural drug design, computer aided drug design, high throughput screening and assay development

Indian Biotechnology Industry

Currently, India holds two per cent share of the global market. With numerous comparative advantages in terms of research and development (R&D) facilities, knowledge, skills, and cost effectiveness, the biotechnology industry in India has immense potential to emerge as a global key player, According to an industry survey, carried out by the Association of Biotech Led Enterprises (ABL:E), the biotechnology industry in India has notched up a growth of 18 per cent during 2008·0'1, earning revenues of US$ 2,67 billion. Exports accounted for nearly 60 per cent of the total business in 2008·09 and went up by almost 25 per cent to reach US$ 1.S7 billion, The domestic business at US$1.09 billion registered a 10 per cent growth in the same period. The blopharma segment continued to account for the largest share of the biotech industry's revenues, In 2008-09, the blopha rrna sector accounted for a 65 per cent share of the total pie with revenues of US$ 1,73 billion. The bloservices sector registered a 31 per cent growth in the period, while the bloagrl sector grew by 24 per cent to reach U5$ 32'1,33 mllllon.

The bloindustrial sector grew by 16 per cent to reach U5$10S.34 million and the biornforrnatlcs sector grew by 15 per cent to touch US$ 48.48 million in 2008-09,

Con tract Ma n ufa ct u rl ng

The global market for contract manufacturing of prescription drugs is estimated to increase from a value of $26.2 billion to $43.9 billion, Asia has recently been challenging North America & Europe's traditional domination of the global pharmaceutical contract manufacturing market. India's entrepreneurial pharmaceutical manufacturers are now beginning to leverage benefits from the introduction of the nation's product patent system. The scientific, techn ical and manufacturing skills, developed under the country's 35-year process patent system, perfectly matches the requirements of global drug manufacture" who are increasingly seeking to offshore many manufacturing activities previously performed in-house.

Con tract Resea rc h

Contract research in generiC pharmaceutical, Is also a significant opportunity. Established generic companies would Hke to o utso u rce 0 r buy se rv i ce sin form u la tio n deve 10 p men t, b io eq u iva le nee te sti ng, sta bi lity st u dies ce n ters, etc. Va rio u s s u rve y, indicate that India has quite a number of resourceful firms In the field of Chemistry providing high quality output in timely schedules, allowing more leads to pursue. India is Significantly ahead' in chemistry services such as analog preparation, a n a I yt I ca I c hem ist ry, fo c US II bra ry, com bin atorl a I [hem i stry, stru ct uta I ch e mistry, st ructural drug design, com p uter aid e d drug design, high throughput screening and assay development.

Medical Tourism

The medical tourism market In India was estimated at U5$333 million in 2004, growing by about 25 percent and this is predicted to become a US$2 bilucn-a-vear business opportunity by 2012:, India is witnessing a surge of patients from developed countries as wel;1 as from Afrlca, South & West Asia because while the cost of comparable treatment in India is about l/Bth to 1/5th ofthe cost in the Western countries, the qualityof Indian healthcare delivery (-in certain institutions) is world class.

Exports of Herbal, Ayurvedic, Siddha, unanl & Homeopathic Products

India with Jts exports of US$8S,98mn Is considered as the major source exporting country for Herbal medicines, Indian exports of medicinal plants grew at B% during 2006 over 2005.

Patent Protection

The new patent regime has also led' to the return of the pharmaceutical multinationals, many of which had left India during the I 970s. Now they are back and are looking at India not only for it, tradltionalstrengths in contract manufacturing but 0,1,0 as a highly attractive location for research and development (R&D). particularly in the conduct of clinical trials and other services. The country is therefore poised to become global manufacturing hub for pharmaceutical industry.

India's Drug Regulatory System

India has a w~11 developed drug regulatory system, The Central Drug Standards Control Organization ICDSCO) set up under Ministry of Health & Family Welfare, Government of India is the Apex drug regulatorv & licensing agency in the country. The organization headed by Drug Controller of India {DCGI) and is responsible for Standards of Drugs, Market authorizations, clinical trails, Import licenses, cGMP, monitoring of quallty of drugs & cosmetics manufactured, pre & post licenstng inspections, etc. Department of Pha rrnaceutlcals under Ministry of Chemicals & Fertilizers is responsible for Pharmaceuticals policy and regulation including price regulation. further, there are state level Drug Control Authorities to inspect and monitor pharrnaceuttcal manufacturing facilities.

Some important laws related to Pharmaceutical sector in India are:

• The Drugs and Cosmetics Act, 1940 • The Pharmacy Act, 1948

• Foreign Trade (Development & Regulation] Act 1992 • Foreign Exchange Management Act & RBI Regulations

• Customs Act 1962, Customs Tariff Act • Central Excise Act 1994 & Rules,

• The Trade and Merchandise Marks Act, 1958 • The Indian Patent and Design Act, 1970

• The Drugs and Magic Remedies {Objectionable Advertisement) Act, 1954

• The Narcotic Drugs and Psychotropic Substances Act, 1985

• The MedicinalandToiletPreparations (Excise Duties) Act, 1956

• The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act)

The overall objective of a National Regulatory Authority INRA) is to ensure that medicinal products are of acceptable quality, safety and efficacy, are manufactured and distributed in ways which ensure their quality until they reach the patient/consumer, and their commercial promotion is accurate. The Drugs and Cosmetics Act of I ndla has laid down that standards of quality of drugs shall be as given in the second schedule to the Act. Any drug including API should conform to the specifications of the prescribed pharmacopoeias or those claimed on the label, In addition, patent and proprietary medicines, Surgical designs, Medical Devices, Mechanical Contraceptives are required to comply with the requirements of the national rules,

A study of samples of drugs tested allover the country in last 5 years by the State Drug Controllers in various states of India, revealed that about 0,3% to 0,4% of around 40,000 samples fell Within the category of spurious drugs. Any product exported from India can only be shipped after due to i:nspection by ORA official posted at Customs ports of the country. India has therefore effective export controls for regulating counterfeit products,

About Pharmaceuticals Export Promotion Council

Pharmaceuticals Expo:rt Promotion Council of India (popularly known as PHARM EXCIL) has been sponsored by the Ministry of Commerce & Industry, Department of Commerce, Government of India to represent the Drugs & Pharmaceuticals and Healthcare Industry in the global arena, PHARMEXCll is mandated to help its members to achieve excellence in export and facilitate overseas buyers to find suitable trade partners from Indian Pharma Industry. To achieve these objectives PHARMEXCll initiates various export promotional activities for the benefit of the exporting community of the Pharrna Products such as,

• Dlssernlnationof Trade Enquiries, • International Trade Statistics,

• Invite Bustness/Trade delegations from overseas to India • Technical Publications,

• Organizing Buyers Sellers Meet both in India and overseas, • E~porters Directory

• Organlzlng and Participating in International Trade Fairs,

• Organlzing Trade/Business delegations from India to overseas markets

• Provide Policy inputs to Government departments to facllltate exports from India,

• Mediate between various Government Departments & exporters to resolve operational problems confronting the

exporters,

• Orga nile National and International sern lnars relating to Pharma products, R&D and pharrna related services. PHARMEXCIL acts as a single contact point for the overseas buyers and investors by provldlng list of manufacturers / exporters of the Pharrna Products of interest to them, provides assistance in co-ordtnatlng appointments for the overseas buyers/investors during their visits to India, through its offices at Hyderabad, Mumbai and New Delhi. PHARMEXCll arranges for visits to manufacturing facilities, research institutes and meetings for overseas buyers with the exporting cornrnunitv for mutual exchange 01 ideas and information,

PHA'RMEXCIL will offer any other services to be a faclhtator for building mutually beneficial relationship between the overseas buyers/Investors and their Indian counterparts to promote export of Pharmaceutical products and services from India. PHARMEXCI!l is the designated Authority for Drugs & Pharrna Sector dealing in Products / Services like,

• Bulk Drugs lAPis)

• Biological Products

• •

Drug Intermediates • Medicinal Plants Product.

D rug Form u latio n s Homeopathy

• •

Biotechnology Diagnostics

• Contract Research • Clinical Research •

• Technologles / Consultancy • Contract Manufacturing

• Nutraceuticals & Phvtorhernlcals •

• Herbal Products IAyurv~da, Slddha & Unani) •

Collaborative Research. Surgical Dressing,

Pharmaceutical Industry Related Services Herbal Products IAyufveda, Siddha & Unani]

INDIA - EI Hub emergentes para el genericos asequibles de Alta calidad

I ntrod u eel 6 n

EI tarnafio del mercado interne farmaceuttca de la lndia (en valor al por menor excepto la contratacion publica V las exportaciones], se situa en apro x, Dolare, de los ELUU. 12.2bn contra dolares de los EE. U U. en 2007 ·0811.08bn creciendo a un saludable 10% ana tras alia.

• La industria farmaceutica India es la slgulente:

• 4 ~ en el mundo en terrninos de volurnen de producclon

• 13 ~ en el valor del consume interne

• 17 ~ en terrnlnos de valor de las exportaciones a granel de actives y forrnas farrnaceutlcas

• EI pais represents el 8% de la producclon rnundlal V

• 2% de los productos farmaceutlcos rnercados mundlales

Las exportaclones de medlcarnentos, productcs farrnaceuticos V productos quimicos fines se situo en dolares de los E E.UU. 8.61bn durante el afio 2008-09 (consulte el grafico 1). Las exportaciones crecleron a una tasa de creclrn iento anual cornpuesta (CAGR) deI21,98% durante el quinquenio 2004·05 a 2008·09.

En terminos generales, Asia es la mayor region lrnportadora, con una cuota de130% de las exportactones farmaceuticas de la India seguida por Europa (24%) y Norteamerica (21%), Africa 116%) y America Latina (8%) (vease el grafico 2).

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Durante 2008-09 los Estados Unidos de America es el destino de las exportaclones superior por valor de H. UU. $ 1.55bn con una cuota de aprox. 18% de las exportaciones tarrnaceutlcas de 10 India, seguido por Rusia IH.U U. S 0.3~bn con una cuota del 3,84%), AJemania lEE .UU,. $ Q.31bn, 3,65%), Austria I EE.UU. $ Q.31bn, .3,58%) y Reina UnldoIen dolares H.U U. Q.27bn, e13, 12%)

Composici6n de las exportaciones de productos farmaceutlcos de la 'India

Fuerza de la lndla en productos tarrnaceutlces genE!ricos:

En el ana 2008·09, aprox. 58% de las axpcrtaciones farmaceuttcas de la lndla compuesta seguida de drcgas a, granel el 41% Y las exportaciones de productcs naturales una cuota del 1% (ver grMico3 V4).

La India es un reconocido a nivel global fuente de alta calidad de los rnedicarnentos genericos asequlbles, con base de provaedores rices, India no es solo una base de fabricacion de la API y la formulation, el pais esta listo para convertlrse en centro de fabrtcaclcn para la industria farrnaceutica del mundo y un centro de lnvestigacion arnergentes del contra to, Biotecnologla, ensavos cllntccs y de gestion de datos cllnlcos, industria farrnaceutica del pais ha mostrado un progreso trernendo en terminos de desarrollo de ta lnfraestructura, la creaclon de base tecnologica y una amplla garna de producclon abarca casi todas las categorlas y forrnas de dosificaclon tarapeutica.

Segun mforrne de PricewaterhouseCoopers, terrnlno genericos suministrados desde la India representan el 20% del: rnercado global de genericos. Se estirna que e.l 70% de los paeientes pertenecientes a 87 paises en desarrollo recibleron rnedlcarnentos adqutrldos en la India par elFondo de las Naciones Unidas para la lnfancla (UNICEF), International Dispensary Association II DA)" el Fonda Mundial y la Fundacion Clinton.

EI pais cuenta con apro x. 1000 la OMS aprobo CGMP plantas farmaceuttcas. Cuenta con 153 Direccion Eurnpea de Calidad Medicina (EDQM) aprobo las instalaciones de fabrlcacion entre los cuales 32 tienen sitios de idoneidad del PAC (Sep. 2008) (consulte el cuadro 1).

La India tlene 1.735 12101) Tlpo-!l activa presentaclones DMF cona FDA de ELUU. de todoslos 5 .. 482 que se prasentarcn OM F 26,76% como en septlern bre 20081ver grafico 5).

Segun datos de la OMS y la investlgacion Pharrnexcil mas del' 90% de las aprobaciones API de antirrstroviratss, antituberculoses V Anti-malaria (precalificeda poria OMS) se conceden a la India. Del total de 4.942 autorlzacionss conced ldas pracalificados por la OMS como en enero de 2009 a 12 parses, la lndia tiene la tercera mayor rurmero de aprobaciones 1621) por 6 ernpresas. Tarnbien tiene el mayor nurnero de aprobaclones de PEPFAR.

Ventajas de Costo de la India

India tiene ventsja de costes de alta en la fabrtcaclon, 1-<' 0 + ensavos cllntcos. EI coste de fabrtcadnn en lalndla se estlrna en la mitad de lao de los palses occidentales y el costa de la reallzaclon de ensavos cllniccs san rnenos del 40% a la de los paises occldentales - Graffeo 6 a contlnuaclon,

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" Fortalezas de la industria farm ace utica india

India tiene ventsja de costes de alta en la fabricaclon, I' -<' 0 + ensavcs cllnicos. EI coste de fabrtcadnn en la India se estima en la rnltad de lao de los palses occidentales y el costa de la reallzaclon de ensavcs cllniccs san rnenos del 40% a la de los paises ccctdentales - Graflco 6 a contlnuaclon.

I. Hayen dla, la India ofrece a. clentlficos callficados I tecnicos I gestion de personal a un costa asequlble. Bajo cOSIo de la mnovacion y msnufactura Gastos de gasto de capital y gastos para ejecutar una instalacion de queja cGMP

2. EI clentiftco, tecnico y las capacidades productlvas, desarrollada bajo ~I sisterna naclonal de proceso de 35 afics de la patente, encaja perfects mente (on los raqulsitos de los fabrlcantes de drcgas a nivel mundial que estan buscando cada vet mas a costa rnuchas actividades rnanufactureras que antes se reallzaban internamente.

3. EI pais ha desarrollado :Ia quirnlca de I + 0 y ,10 infraestructura de producclon COn experlencia probada en 'las capacldades de qulrnlca avanzada, dlsefio de lnstalaclones de fabncaclon dealta tecnologla y el curnpllrnlento regula to rio.

4. Es ronncido por su ccmpetencia en API / creaclon de Formulacion de la Propied'ad lntelectual, disefio y rnantenirnlento de lnstalaciones, de asuntos regulatorios globales, lao perspicacia juridic" yla gesti,on de la fuerza de trabajo internaciorial

5. India nosolo por sus tradlcionales fortalezas en la fabricaclon de ccntrato, sino tarnblen como una zona de gra n atrartivo para la lnvestigacion y desarrollo (I + 0), especlalrnente en la reallzacion de ensavos clfrucos y otros servlcios como el desarrollo de la forrnulaclon, pruebas de bloequlvalencia, estudios de centres de estabilid'ad, etc

6. La India tiene un buen nurnero deempresas de recurscs en el ambit(} de la Oulrnlca proporclonar alta calidad de salida en las llstas a tiernpo, perrnitiendo que mas lleva a cabo.

7. La India est", slgnificativamente por encirna de los servicios de la qulrnica como la preparacion analoglca, qulmtca analltlca, la coleccion de enfoque, la quirnica combinatcna, qufrnlca estructural, dlsefin de farmacos sstructural, disefio de farmams aslstido por cornputadora, el cribado de alto rendimiento y desarrollo de ensavos,

Sedor de la biotecnologia india

Actualrnsnte, la India cuenta con dos por ciento (2%) de partlclpaclon del rnercado global. A traves de nurnerosas ventajas cornparatlvas en terminos deinvestigacion y desarrollo (I -<' D) i nstalaclones, los conoornlentos, habilidades, y la rentabllldad, la lndustrla de Ia blotecnologia en la India tiene un inmenso potencial para ernerger como un actor clave global. De acuerdo con una encuesta de la industria, llevada a cabo por Ia Asociaci6n de Ernpresas de biotecnologia Led (AEBA), la industria de 13 biotecnologia en I, India ha ganado una creclrn lento del 18 per ciento dura nte 2008-09, ganando unos lngresos de 2,67 mil millones dolares EE.U U ..

Las exportaciones representarcn casi el 60 por ciento del negocio total en 2008-09 y aurnento en un 25 par clento casl de llegar a EE.UU. $ 1,570,000,000. £1 negocio dornestico a 1,09 mil rnlllnnes dolares fE. U U. registro un 10 por ciento de creclrnlento enel rnlsrno period'o.

EI segrnento de biofarrnaceutica siguleron representando la mayor proporcion de los ingresos de la industria de la blotecnologla. En 2008-09, el sector btofarmaceutlco representan un 65 por ciento de las accionas de la torta con unos lngresos de 1,73 mil millones dolares EE.UU .. EI sector registro un bioservlces 31 par clento de creclrnlento en e:1 pertodo, rnlentras que el sector credo bioagrl en un 24 par ciento parallegar a fLU U. 329,33 millones dolares,

EI sector crecio btolndustriales en un 16 por ciento para llegar a EE.UU. 105,34 millones dolares v el sector blomforrnattca aurnento un 15 por ciento de tocar 48,48 rnillones dolares fLU U. en 2008-09.

Fabrication por Contrato

EI rnsrcado rnundial de fabrlcaclon per contrato de rnedlcarnentos con receta se estirna que aurnentara a partir de un valor de 26,2 mi,1 rnlllnnes dolares a 43,9 mil millones dolares, Asia ha estado desafiando Am~ri(a del Norte y Europa ta dorninaclon tradlclonal del' rnsrcado global de farmaceutlccs de fabricacicn por contrato.

Empresarial fabrlca ntes de productcs farrnaceutlcos de la India estan cornenzando a aprovechar los beneflcios de ia mtroduccton del sistema nacional de patentes de prouuctos, EI clentlfico, tecnico y las capacidades productlvas, desarrollade ba]o el sistema naclonal de proceso de 35 a nos de la patenta, encaja perfactamente con los requisitos de los fabricantes de drcgas a nivel mundial que estan buscando cada vel mas a costa rnuchas act, vida des rnanufactureras que antes se realtzaban lnternarnente.

Contrato de Investigadon

lnvestlgaclon por contrato de productos farrnaceuttcos genericos es tarnblen una oportunldad slgntficatlva. Establedda las ernpresas de generkos gustarla subcontratar a contratar serviclos en el desarrollo de formulation, pruebas de bloequlvalencla, estudics de centres de estabtlldad, etc

varios estudios indican que la India tiene un buen nurnero de ernpresas de recurscs en el ambito de ta Quimica proporclonar alta calldad de salida en las lisla, a tlern po, perrnitlando que mas Ileva a cabo, la India esta slgmflcativamente par enclrna de 10, serviclos de la quimica como la preparacion analogica, qufrnica analltlca, la coleccion de enfoque, la qulrnica cornblnatorta, quimica estructural, disefio de farmacos estructural, dlsefio de farma.co, asistldo por computadora, el crlbado de alto rendlrnlento V desarrollo deensavcs.

Turismo Medico

EI mercado del turisrno medico en la India se estirnn en 333 rrnllones dolares EE.UU, en 20M, creclendo un 25 por clento yse pr~ve para convertlrse en dolares de 10, EE ,U U. 2 mil mill ones de a fics-la oportunidad de negccio para el afio 2012, La India esta siendo testlgo de una oleada de pacientes de palses desarrollados, asl como de Africa, Asia meridional y Asia occidental porque rnientras que el coste del tratarnianto comparable en la India est" a punto de 1/80 1/50 de los costos en los palses occtdentales, la calidad de los indios prestacion de asistencia sanitaria [en algunas lnstituciones] es de clase rnundlal.

Las eKportaciones de hierbas, AVurveda, Siddha, Unani V I'os productos homeopaticos

I ndla, con sus exportactonas de dolares de los EE.UU, 85.98mn se consldsra como la fuente principal pais exportador de hlerbas rnedlctnales.Ias exportacioneslndlas de las plantas rnedlcinales credo a un 8% dura nte 2006 respecto a 2005.

Proteccion de Patentes

EI nuevo regimen de patentes lam bien ha dado lugar a la devolucion de las rnultlnactonales farrnaceuticas, rnuchos de los cuales hablan abandonado lalnd!a durante la decada de 1970, Ahora esta n de vuelta y que busca en la India no solo par 'us tradlclonales fortalezas en la labricaci6n de contrato, sino tarnbien como una ZOna de gran atracttvo para la lnvestlgacion y desarrollo (I + D),. especialmente en la reallzacion de ensavcs dfnicos y otrcs ssrvlcios, EI pais esta ltsto para convertirse en centro de produccion rnundial parala industria farmaceuttca,

Sistema regulador de medicamentos de lalndia

India tiene un sistema blen desarrollado de reglarnentacion de' rnedlcarnentos, La Central de Normas de Control de Drogas Organlzactcn ICDSCO) estableeido por el Ministerio de Salud y Blenestar Familiar, Gobierno de la India es la droga de Apex agencla regula dora y de concssion de licenctas en e,1 pals, La organlzaclon encabezada por el Contralor de Drcgas de la lndia (DCGI) y es responsable de las normas de las drogas las autorizaciones de cornerciailzacion, ensavos dlnlccs certlficados de lmpcrtaclon, el cGM P, el control de calldad de los medicarnentos V 10' cosmeticos fabricados, pre y post lnspecclones de licenctas, etc. Departamento de Farrnacia a cargo del Mini,terio de Productos Ouimicos y Fe'rtilizante, responsable de la polltica y la regulaclon de productos farmaceuticos lncluvendo la regulaclcn de preclos. Adsmas no hay a n ivel estatal de Control de Drngas autortdadss de mspecctonar y supsrvisar las lnstalaciones de fabrtcacion farrnaceutlca.

A'igunas leVes importantes relacionados con el sector farmaceutico en lalndia son los siguientes:

• La l~y de Dragas y Cosrneticcs de 1940 • La L~y de Farrnacla, 1948

• Comercio Exterior (Desarrollo y Reglamentaclon) de 1992 • ley del regimen de cambia V RBI Reglamento

• Ley de 10' lrnpuestos Especlales Central 1994 y Reglamento,. ley de Adua nas de 1962, Ley de Aduanas arancel

• EI cornerclo de rnercanclas V Ley de Marcas de 1958 • La Ley de Patentes de la India y Olsefio, 1970

• Las drogas y remedios rnaglcos [Publlcidad de dudosa reputacion), de 1954

• La Ley de Estupefacientes V Sustanclas Sicotroplcas de 1985

• Los rnedicarnentcs y productos de tccador [impuastos especlales], 1956

• La Drnga I Precios control) de 1995 len virtud de la Lev de los productos basicos)

EI obJetivo general de una autortdad nacional de reglamentacidn (ANR) es asegurar que los medicarnentos sean de calldad aceotable, segurldad V eficacia, se fabrican y distribuyen de rnanera que garanticen su calidad hasta que, Heguen al paclente / consurnidor, asl como sou promoclon cornercial es precise,

La Ley de Drogas y Cosrnetlccs de la India ha establecido que las norrnas de ca lidad de los rnedlcarnentos sera el indlcado en el segundo anexo de la ley. Cualquier medicamento induyendo API debe ajustarse a las especlficaciones de las farrnacopaas prescrito 0 los redamados en la etlqueta. Ademas, las patentes y los medicarnentos patentados, 1.05 diseFios qulrurglcos, dlsposltivos medicos, antlconcepttvos rnecanicos estan obligados a curnpllr con los requisites de las normas nacionales,

Un estudlo de rnuestras de drogas probadas en todo el, pais en los ultimos 5 afios per los controladores Estatal de los Medicamentos en varies estados de la India, revelo que alrededor del 0,3% al 0,4% de los alrededor de 40.000 rnuestras cava dentro de la categorla de rnedicarnentos fatsos, Cualquier producto axportado de la India solo puede ser enviadc despues debldo a la inspeccion par agentes del DRA publlcado en los puertos de Aduanas del pais. lndla, por 10 tanto los controles de exportacion eficaces para la regulacion de la falslficacion de prcductos.

Sobre los productcs farmaceuticcs de exportacion Consejo de Prornoclon I Pharmaceuticals Export Promotion Council of

I. ndia] [Popularrnente conocido como PHARMEXCIL) ha side patrocinado por el Ministerio de Comercio e Industria, Departamento de Cornerclo del Gobierno de la India para representar a la Droga y Farrnaceutica e Industria de la Salud en el ambito mundlal.

PHARMEXCIL tiene el mandata de avudar a sus miembros para lograr la excelencia en la exportacion y facllltar los cornpradores extranieros para encontrar sorros adecuados de cornercio de la India de la industria Fa rmaceutlca. Para lograr estos objetivos PHARMA inicia la exportacion diversas activldades de prornoclon en beneflcin de la comunidad de exportadores de los productcs farmaceutlcos tales como:

• Dlfuslon de Consultas de Cornerclo,

• Estadisticas del Comerclolnternaclonal,

• Organizaclon de Cornercio / Negodos dalegaciones de la India a los rnercadcs de ultrarnar

• mvitar alos negoclos I Cornerclo delegaclones del extranjero a la India

• los cornpradores Organizador vendsdores se encuentran tanto en India como en el extranjero,

• Organlzacion y participacion en ferias cornerclales internacionales,

• Publicaclones tecnicas

• Directorio de Exportadores

• Proporcionar los insumcs de politica para los departarnentos del Gobierno para facllitar las axpcrtaclones de la India,

• Mediar entre los distintos departarnentos gubernarnentales y los exportadoras a resolver los problemas operatives que enfrsntan los exportadores,

• Organizer sernlnarlos nacionales e internacionales relativas a los productos de Pharma, R + D farmaceutlca y servicios relaclonadcs.

PHARMEXCIL actua COmo un punta de contacto unico para los cornpradores de ultrarnar y los inversores al proporcionar la lists de fabricantes y exportadores de los Productos Pharrna de interes para ellos, presta aslstencia en la coordinacion de citas para los cornpradcras en el extranjero e lnverslnnlstas durante sus vlsitas a la India. a traves de sus oficinas en Hyderabad, Mumbai y Nueva Delhi,

PHAHMEXCIL organlza visitas a las fabrieas, instltutos de lnvestlgacion y reuniones para los cornpradores extranjeros COn la comunidad de exportadores para el mtercamblo rnutuo de ideas e informacion.

PHAHMEXCIL ofrecera otros servlcios paraser un facilltador para la construcclon de relaclones mutuarnente beneftclosas entre los compradoras extranjerns e inverslonistas y sus hornologos de la India para prornover la exportaclon de productcs y serviclcs farmaceuticcs de la india.

PHAHMEXCll ha sido dasignado como Autoridad de la droga y del sector farmacsutlco la negcciacion de productos I servlcios como,

• Drogas a granel (API)

•

lnterrnedlarlos de Drogas Blotecnologla

Plantas Medidnales de productos nutraceuticcs y fltcqulmicos Contrato de investigaclon lnvestigaclon Clfnica

Tecnologlas I Consultoria Colaboracion en lnvestigacion

• Forrnulacinn de Drcgas

• Productos Blologicns

• Horneopatla

• Diagnostico

• Fabricaci.on de Contrato

• los a p osltos qui ru rgicos

• Productos a base de plantas (Ayurv~da, Slddha y Unani)

• Serviclos relacionados con el Industria Farrnaceutica

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•

•

•

•

•

•

An. Badrina,th Apartment, Shirnpoll Road, Borivali (W), Mumbai - 400 092,lndla.

Tel, +91-22-2B926417/+91-22-28923618 Fax: +91-22-28920082

E-mail: sales@aadlvighnesh.com.aadl@vsnl.net

Name of the delegate: Mr. Shah Oevang Biplnbhai Designation: Director

Company Profile: Aadivlghnesh Chern Pvt. Ltd. is a manufacturer and exporter of pharmaceutical raw material &finishedformulation.

For more details please visit Our web stte www.aadivighnesh.com

AUROCHEM LABORATORIES (I) PVT. LTD.

333, Gundecha Industrial Complex, Akurli Road, Kandivall (El, Mumbai - 400101, India.

Tel, +91-22-42508181 Fax: +91-22-28873236

E·mail, a urochem@mtnl,net.in, au rochem@vsnl,ln,

I nfo@aurochemlaboratories,com Website: www.aurochemlabora.tories.com Name of the delegate: Mr. Dipak Desai Design at I On: Director

Company Profile: Aurochem is a leading manufacturer and exporter of finished formulations in Tablets, capsules, Oinment/Creams and liquids/Syrups forms. Auroehem has a rare distinction of manufacturing more than 450 products in Its facilittes, which are WHO-GMP a ccredite d across the wo rid.

Au roeh e m h ave va ried product ra n ge in the Th e rapeut i c segment, which ranges from Cardiovascular, AntiDiabetics, Anti-Malaria, NSAIDS, Anti-Bacterial" Impotence drugs, Lipid lowering drugs, Anti-ulcer, Ne u ro- p sycotro pi cs, Dermato I oSi ca Is" V I ta min sand Anti-retrovlral, The new product range that has been introduced is the Cosmetics and Nutraceuticals.

For more details pl e as s visit Our web stte www.aurochemlabora.tories.com

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28, Mehta, Vora Chambers (Mahendra Mansion), Babu Genu Road, Mumbai· 400 002, India.

Tel: +91-22-22077266/ +91-22-22086900

Fax: +91-22.-22086900

E-mail!:raj@adh.co.ln

Website: www.apexdrugsindia.com Name of the delegate: Mr, Rajesh Bhayanl Designatio n: Director

Campa ny P ref le: Ape .• Drugs Ho use I sam an ufactu rer of ge nerl cs and bra nded gen e rics ex p a rti ng to South America, Africa, Far East and Middle East. They have Oral, lnjectables, Liquid Orals & Topicals facillties. They can provide reg I strat I on doss lers with CTD form at and BAI B E where required, their manufacturing facilities are WHOcG M P a pp roved and fo Ilow st rict va I I d at I on process fa r every stage of manufacturing & quality control, They are an ISO 9001:2000 certified company and "A government of India recognized export house" by the ministry of commerce. They manufacture generics in the client's brand as required in the country of import. Products:

F ini shed Form u I atl on s, Act I ve Ph arm aceut i ca Is Ingredients, Antibiotics, Drug Delivery systems and Exci pie nts,

For more details please visit our web site www.apexdrugsindla.com

AXON DRUGS PVT. LTD.

K-95, K Block, 16th Street, Annanagar East, Chennai - 600102, India.

Tel: +91-44-42171424/ +91-44-42171425 Fax: +91-44-43500673

E-maill:info@a.ondrugs.com Website: www.axondrug.s.com

Name ofthe delegate: Mr. Damodararn Harlrsjan Designatio n: Man a 8 i ns Director

Company Profile: AXon nrugs Pvt. Ltd. is a manufacturer & experts rs of P ha rm ace utica Is Form u I at ions with a unit Situated at about 25 krns from Chennai.

For mo re deta i Is pie ase vis i t ou r web site www.axondrugs.com

3B, Patanwala Ind. Estate, Opp. Shrevas Cinema, L.S.s Marg, Ghatkopar (W), Mumbai - 400 086, India. Te": +91-22-25005245/ +91-22-25005246

Fax: +91-22-25004893

E-mail: exports@coral.ab.com Website: www.corallab.com

Name of the delegate: Mr. Dhameja Girish Madan D e.s ign at i On: Asst. Ma n age r - Expo rts

Name of the company: Coral l.abnratorles Ltd. is one of the re puted Man ufactu re r & Exporter h avi ng ce rtifi catio n of WH 0 G M P and I SO 9001: 2000 exporti ng in more tha n 28 co u ntrl es. Th ey man ufactu re a II doss ge s, like Tablets, Capsules, Liquids" Dry Syrups, Cream, Ointment, Powder, External Preparation Gel and also have sepa rate fad lity fo r Beta la ct u m a nd low R H products. Coral has a wide range of products in key therapeutic segments such as, Antibiotics, Antibacterial, Vitam inS upp I ement, I ron Supp lernent, Antacid, Antiu leer, Antispasm ollc, Analges,i c, Anti pyreti c, Expectorant, Cardiac Medicines, Herbal Medicines, Tropical preparations. They also undertake Contract Ma n ufa cturi ng and Th i rd Party Ma n ufa ctu ri ng fo r loca I and expo rt rna rket,

For more details please visit our web site www.corallab.com

FOURRTS (INDIA) LABORATORIES PVT. LTD.

Plot no. 1, Fourrts Avenue, Annailndira Nagar, Okkivarn Thnraipakkam, Chennal -600 097, India.

Tel: +91-44-24581899/ +91-44-24581199

Fax: +91-44-24581199

E·mail: export@fourrts.com.Website:www.fourrts.com Name of the delegate: Mr. Bhamrnar kaushlk De.signation: Asst. General Manager· International

Company Profile: Fourrts [lndia] Laboratories Pvt. Ltd. are one of the leading fi rushed pharrnaceutlcal form u I ali on dosage man ufact u re rand ex po rter bas I'd at Chennal, South India. !Fourrt.s is in business for more than three decades and have ISO Certified; WHO-GMP approved manufacturing facility for Tablets, Capsules, Liquids Orals, Creams, Ointments and Medicated Toothpaste. Their R&D i,s approved by Department of Science and Technology, Government of India. They are recipients of 7 times Quality Excellence Awards instituted by All India Drug Manufactuners Association, Managerial Excellence Award from Madra,s, Management Association, 5S certification and Industrial Safety awa rd.

For more details please visit our web stte

4'" Floor Dalamal House, J.S, Road, Nariman POint, Mumbai -400 021, India.

Tel: +91-22-22853910/ +91-22-22853911 Fax: +91-22-22825753

E-maill:exports@corallab.com Website: www.corallab.com

Name of the delegate: Mr, Doshi Chetan Navlnchandra Designation,: CEO

Company Profile: DWD Pharma,ceuticals Ltd. is one of the 100 Companies of ORG Ranking and has an Ethical P romoti on th ro ugho ut I h e CO u n try. Be i ng a Me rcha nt Expo rte r OW D a I ms at exportl ng the be st qua lity prod u cts and esta b I is h es thei r p resenee in In te mati on a I Markets. They cover all the dosage forms viz, Tablets, Capsules, l.lquids, Dry Syrups, Cream, Ointments, Dry Powder, Injectables & Sterile Products (including Betalactum and Cephalasporins].

For rn o r e details please visit Our web site www.corallab.com

IDEAL CURES PVT. LTD.

6th Floor, Elecon Chambers, Andheri Kurla Road, Andherl IE), Mumbai -400072, India.

Tel: +91-22-42688700/91/ +91-22-66764491/94 Fax: +91-22-66764495 E-maill:srp19@vsnl.com.info@idealcures.co.in. Website: www.idealcures .. co.in

N am e of th e delegate: Mr.Jite n Shrid h a r Su rve Designatio n: Sr. Manage r - Tech n i ca I

Company Profile: Ideal Cures is involved in ph arm ace utica I bu si n ess for ave r 3 deca d es. Of thos e, they have been specialized in the firm coating s,ystem arena for nearJy a decade. The company has state-of art facilities located in Vasai near Mumbai and in Jammu in the state of Jammu & Kashmir in northern India. Over the years Ideal Cures has remained dedicated to quality, resea rch & d evelo p m e nt, suff c i e nt ca pacily, cG M Pan d global regulatory requirements. Their manufacturing facilities are built to global standards. Ideal Cures is s p ecia I i zed in th I' field of F i I m Coati ng Syste m s. They develop, manufacture and supply INSTACOAT ready mix fi I m coat i n g system fo r the ph a rma ceu tica Is, Nulraceutica Is, Veterinary, Herbal, Ayurvedic and Chinese Medicine,

please visit ou r web

101. Blue Bell Building, Sltararn Compound, Crawford Market, Mumbai -400 001, India.

Tel, +91-22-23455354/55/ +91-22-23455220 Fax: +91-22-23476536 E-mail.info@indogulfgroup.com. indogulfco@gmail,com

Website: www.indogulfgroup.com

Name of the delegate: Mr. Sayed Tanzil Ismail & Mr. Shaikh M Shafique A Rahim

Designation: Export Manager & Business Analyst

Company Profile: An ISO 9001-2000 & WHO GMP Certified Pharmaceuticals Finished Formulation & Bulk d ru g expo rte rs,

For more details please visit Our web site www.indogulfgroup.com

LABDHI PHARMACEUTICALS

Unit no. 7, Natalwala Terra,ce, 53, Gokhale Road (South), Dadar (W), Mumbai - 400 02B, India,

Tel.: +91-22-66101752 Fax: +91-22-66101753

E-mail: labdhipharrnagrredlffmall.com, labdhipharma@gmail.com

Name ofthe delegate: Mr. Bharat Hargovlnd Shah Designation: Partner

Company Profile: La,bdhi Pharmaceuticals enjoys as imperious presence in the global pharmaceutlcal Industry today since 1981, The humble pride sprout as much from its cost efficient and quality products as from modesty and an ethical value system.

10/0, Matru Ashlsh, Near Balbharti School, S. V. Road, Kandlvali (W), Mumbai - 400 067, India.

Tel: +91-22-67141516/28643431/28072182 Fax: +91-22,-28640377 E-maill:info@jpnpharma.net

Website: www.jpnpharma.net

Name of the delegate: Mr, Shah Jayesh Popatlal Designatio n ,: Director

Company Profile: JPN Pharma Pvt. ltd, is one of the largest ma nufact u re r of Ca P role Anhyd ride & Si I ver Su I P hadi a, i n e having sophisticated plant ISO Indian GMP complaint WHO GMP by Dec 09 manufacture API's Alendronate Sodium Ibandronate Sodium Pamidronate Disodium Risedronate Sod ium Amlodipine Besyla.te Fosphenytoin Sodium Phenytoin Sodium Tizanidine Trimetazidine Pioglitazone B i sa cody I P.ico 5 ulfate S odi u m Pro pyl Ga Ilate FI uore scel n Sodium Eosin Disodium Methylene Blue Drug Intermedia.te 4Aminobutyric Acid 3N methylpenthylamino propionic acid HCI Benzoin Benz.il.ic Acid Heptanoic Anhydride Gallic Acid Methyl Gallate, 2, 3, 4 Trimethoxy Benzaldehyde SChloro 4Amino 2, 1, 3 benzothladlazole Ethylene Urea Ac"tyl Et hyle ne Urea Pota ssi u m Hyd roxi de Powd er, S i lver N ltrate Parabromo Aniline, S-[4-[2-[S-Ethyl-2-Pyridyl) Ethoxy] p he nyl J methyle ne- 2 -4th i a zol id in edio n e.

Fo r mo re det alls p Ie as" visit 0 ur web sit"

LACTOSE (INDIA) LIMITED

211, Laxmi Plaza, Laxrni Industrial Estate, New Link Road, Andheri (W), Mumbai -400 053, India.

Tel: +9122. 66952701/ +9122 66952702/703

Fax: +9122 66952704 E-maill:lactose@vsnLcom.atul.lactose@gmail.com

Name of the delegate: Mr. Maheshwari Atul Designation.: Executive Director

Company Profile: Lactose (lndla] is a WI-IO-cGM P approved facility, having ISO 9000-2001 Certification as well as being gra nted Export House Status by Government of India. With up-to-date technology, the company is One of the leading Producers & Exporters of Edi bl e lactos e and Ph arm a ceut i ca ls Grade Lactose, Apart from this, the company is also a contract loan licensins Manufacturing Exporter of liquid orals and tablets. Lactose (India) Limited is looking for Importer & Exporters of Pharmaceutica I s Form ulations and Da i ry /Food prod u cts,

814. Devpath, B/H Lal BUnglow,OffC.G. Road, Ahmedabad -380 006,lndia.

Tel.: +91·79·26431236/ +91·79·26430318 Fax: +91·79·26426672

E·mail: vipul.mohan@macheal.in Website: www.macheal.in

Nameofthe delegate: Mr. Vipul Mohan D esign at i On: Man agi ng Director

Company Profile: Matheal Laboratories Ltd. since inception (2003) stands different among many common, The company is into formulations of drugs & medicines. Macheal Labs ltd. already has an impressive and lrnpeccable achievement of having their wings of success spread across the globe by rnaintalnlng and achieving global hea lthcare sta ndard backed by contemporary marketing strategies. Their business. objective is to achieve leadership in all possible key therapeutic areas. It is always their endeavour benefit for One & all. They assure you a complete range of formulation under One "Single roof.

For more details please visit Our webSite www.macheal.in

PHARMCHEM

1568/8, Bhagirath Palace, New Delhi ·110 006, India.

Tel: +91·11·23536029/ +91·11·23536340 Fax: +91·11· 23554027

E·mail: phrmchem@hotmail.com

Nameofthe delegate: Mr.Jain Nipun Designation: CEO

Company Profile: Pharmehem are WHO·GMP & ISO certified leading manufacturer of qual.ity bulk drugs. and life saving medicines wtth an experience in this Industry for more than 32 yrs. They are totally dedicated to customer satisfaction.

10, Community Centre #2, Ashok Vihar, Phase 1:1, Delhi ·110 052, lndla.

Tel: +91·11·27463506/ +91·11·47589500 (30Hnes) Fax: +91·11·27238171

E·mail: rs.adhikari@medicamen.com Website: www.medicamen.com

N am e of th e delegate: Mr. G upta Ash utosh Designation.: Executive Director

Company Profile: Medicamen Organlcs Ltd. is One of the group company of Medieamen Group involve into manufacturing and exportation of pharmaceuticals formulations in dosage forms Le. Tablets, Capsules, Dry Syrups, liquid Orals & Creams. MOL is having ultramod e rn pi ants, in corp orati ngsta,te·of·the·a rt technology at Harldwar, Uttarakhand in India. After successfully venturing to domestic market, MOL now a ggressive I y march i n g a head into Expo rt market.

For rn o r e details please visit Our web site www.medicamen.com

PROTECH Bl0SYSTEMS PVT. LTD.

145·146, Sector·37, Pace City· I, Gurgaon, Harvana • 122 001, India.

Tel: +91·124-4687000

Fax: +91·124·4687007

E-rnall: sanjiw@protechbi.osystem.com, sanjiw@gmail.com, ajay@protechbiosystem.com Website: www.protechbiosystem.com

Name of the delegate: Dr. Sanjiw Kumar Singh Designatio n: Ch a i rm a n & M a nagl n g Di re cto r

Company Profile: Protech Bimciences Pvt. Ltd. was incorp orated in 1998. Ea rlier itsta rted man ufact u rl ng the pharmaceuticals product on loan license in India and exported the same. Today, Proteeh Biosystems Pvt. Ltd. h as its ow n man ufact u ri n g pi ant and is a ma n ufactu rer, distributor-cum-export house. The company operates in 12 states in In d ia for its do m e stic s a I es be sld es expo rts to Russ i a & CI S count rles. The com p any del lvers abo ut 50 prod u cts fo r exports and d ornest i c rna rket. Th e com p a ny has gained a reputation of a reliable supplier of health care products in India, Russia. and CIS countries.

For rn o r e de t alls please visit Our web www.protechbiosystem.eom

Ray House, 112000, HIG, Next to Yelahanka, New Town Police Station, Bangalore - 560064, India.

Tel, +91-80·28561041/ +91-80-28561042 Fax: +91-80-28566630

E·mail, anjan@blr.v,slll.neUIl, rlfillechem@eth,net

Name of the delegate: Mr. Mannappa Ramchandra Designation: Manager - Marketing

Company Profile: R, L Fine Chern is a part of Ray Group of Companies. They are an USFDA approved, having COS, W H O-G M P ce rt ified, rna nufactu ri ng pro ducts as per I C H guidelines, Japanese Accredition obtained also having ISO 9001 certification, Their main products are Alprawlam, Amitriptyline, Imipramine, Clomipramine, Doxylamine, Succinate, Pitofenone, Fenpriverinium B ro mid e, Pro p iveri n e, Or p he n a d ri ne cit rate, Haloperidol, Nortriptyline, Carblnoxarnlne Maleate, Valethamate Bromide, Lorazepam, Pyrimethamine, Temazepam, Trimipramine Maleate.

SAHUL INDIA LTD.

26, Hemanta Basu Sarani, Mangalam B, Kolkata - 700 001, India,

Tel, +91-33·22424159/ +91-33-22480533 E·mail:sahul@sahul.com.itsrashmi@gmail.com Website: www.sahul.com

Name of the delegate: Ms Rashmi Singh Chauhan De,signation: GM - International Bu,siness

Company Profile: Sahul India ltd, is a G MP Certified company based in India. Sahul manufactures, markets and exports pharmaceuticals and herbal cosmetics in Ind ia a nd a broa d. Sa h u I bel ieve sin q u a,lity. The prod u cts manufactured under the Brand name "Sahul" have a huge demand in domestic as well as international markets, The manufacturing process complies SOP's as prescribed to maintain the standards and uniformity. Adequate quality control measures are adopted including in-process quality check. The finished products, packed in most scientific and harmless packaging materials, go through stringent quality control test before being cleared for consumption by end users, Hence, the manufactured products released for sales are of highest International standards. For more details please vistt

HIG 2000, Ray House, Yelahanka New Town, Bangalore - S60 106, India,

Tel: +91-80-28561041/ +91-80-2,B561042

Fax: +91-80-28556630 E-maill:anJan@blr.vsnl.net.in.rlfinechem@eth.net

Name of the delegate: Ms Trlshna Roy Designatio n ,: Director

Company Profile: Ray Chemicals is a part of Ray Group of Companies. They are an USFOA approved, having COS, WHO-GMP certified, manufacturing products as per ICH guidelines, Japanese Accredition obtained also having ISO 9001 certification. Their main products are Amitriptyline, Imipramine, Clomipramine, Doxylamine, Succi nate, Potofenone, Fenpriverl ni urn Bromide, P ropive rine, a rph anadrl ne citrate, Haloperidol, l.operamlde, Nortriptyline, Carbinoxamine Maleate, Fuphanzlne, Flupentixol, Melitracin, Flupenazine hd/deconate, Valethamate Brom ide, Pargevarine, Bromazepam, Clonazepam, l.orazeparn, Alprazolam, Diazepam, Ternazepam, Oxazepam, Phenazepam.

SG PHA,RMA PVT. LTD .

.542, 3/10, Bhuta Niwas, Dr. Ambedkar Road, Matunga (E), Mumbai -400019, India,

Tel: +91-22-241.52010 Fax: +91-22,-241.51565 E-mail: bhagat@sgpharma.com

Website: www.sgpharma.com

Name of the delegate: Mr, Chetan Klrltkumar Bhagat Designatio n: Director

Co m pa ny Profi Ie: S G Ph a rrna Pvt. Ltd. a re the man ufact u rer of worl d -class life savl ng p rodu cts (i n WH O~GM Pap proved facilities) viz; Cardiovascular, Antibiotics, Neurological, Anaesthetics, Anti-Microbial" Hormonal: & Infertility, AntiFunga'l, Anti-Cancer, Corticosteroids, Sclerosants. Many of their products are niche and orphan drug" which are rna n ufa ct u re d by very few com pa n ie s/ on Iy th e in novato r, Their major Cardiovascular products are: Alprcstadil (Prostaglandin E'I) lnj., Adenosine, Amiodarone, Amrinone, Atenolol Inj., Calcium Oobe.silate capsules, Dobutamine, Esrnclol, Heparin Sodium lnj., Low Molecular Weight Heparin (Enoxoparin) Inj., lsosorblde Dinitrate I n], lsopren a line, La betalol, M ilrinone, Nitroglycerine, Nifedipine Extended Release Tablets, Norepinephrine, Phenoxybenzamine, Phentolamine, Phenylepherine, Propranolol, Reserpine tablets, Veraparnil.lnjection.

For more details p lease visit our web site

542.1/10. Bhuta Niwas, Dr, Ambedkar Road, MatungaIE), Mumbai· 4()0 019, India.

Tel: +91·22·24152010 Fax: +91·22·24151565 E·mail, bkbhagat@sgpharma.cDm

Websi,te: www.sgpharma.cDm

Name of the delegate: Mr. Bhavesh Klritkurnar Bhagat Design at i on: Man agi ng Director

Co.mpany Profile: Shree Ganesh Pharmaceuticals are the man ufa ctu re rs & ex porte rs of wo rld-class life savi n g produ cts [i n W H O·G M Pap proved facil ities) viz; Cardiovascular, Antibiotics, Neuro'iogical, An:aest;hetics1 Anti·Microbials, Hormonal & Infertility, Anti·Fungal, Anti· Can ce r, Cortlcostero i d 5, Sci erosa nts, Many of th ei r produ cts are niche and orphan drugs, which are manufactured by very few cornpanles/onlv the tnnovator, Their major Cardiovascular products are: Alprostadil (Prostaglandin Etl lnj., Ade'nosifle) Amiodaronel Amrinone, Atenolol lnj., Calcium Oobesilate capsules, Dobutarnjne, Esrnolol, Heparin Sodium Inj., Low Molecular Weight Heparin [Enoxoparin] lnj., lsoscrblde Dinitrate lnj., Isoprenaline, tabetalcl, Milrinone, Nitroglycerine, Nifedipine Extended Release Tablets, N orep i nephri n e , Phenoxybenzam i n e , Phentolamine, Phenvlepherine, Propranolol, Reserpine tablets, Verapamil Injection.

For more d e t a ils please visit ou r web site www .. sgpharma.com

SUNil PHARMA PVT. LTD.

T·l/B, National Park, Gulbai Tekra, Ahmedabad· 380 015, India.

Tel: +91·79·26304045 / +91·79·26304226 Fax: +91·79·26304226

E·mail: sunijpharma@youtele.com.

drvsp22@gmail,cem

Name of the delegate: Dr. Parikh Vallabh Sunderlal Design at i on: Med i ca I 0 i rector

Company Profile: Sunl] Pharma Pvt. Ltd. is a SSI Unit having Global Quality Assurance Certification like WHO GMP / DGQA/ DGHS/ etc, MDre over dedicated facilities to Manufacture General capsules and General Tablets and having specified facilities to manufacture Rifampicin Formulations Company is engage in manufacturing its Own Formulation as well as having Jobwork from many multinational companies on Loan License as well as Contract Manufacturing basis.

Sunij Pharma Pvt. Ltd. is having dedicated separate unit to manufacture FODd Products and Low Calories Sweeteners pellets and Liquid of Saccharin Sodium, Aspartame, Sucralose. This unlt is holding PFA License as well as facilities approved by HACCP and ISO 9001·2008.

17, 8th Floor, Devpath, B/H Lal Bunglnw, Off e.G. Road, Ahmedabad - 380 006, India.

Tel: +91·79·26441993/+91·79·26568501 Fax: +91·79·26560543

E·maill: info@stallionlabs,com E-rnall: www.stdllionlabs.com

Name ofthe delegate: Mr. Vijay J Shah Designatio n: Man a g i ng 0 i rector

Company Profile: Stallion Laboratories (P) ltd. India is a CD m pa ny with an un mate h ed record of rna n agi ng niche products in the formulations & herbals and is WHO·GM P, ISO 9001·2008 Certified Company, They have their own State-of-Art factory in Gujarat, India. They offer Tablets, Capsules, Liquids, lnjectables, PDwder and Soft Gelatin Capsules, They export their medicines, to' eighteen countrlss, SOme of them are Francophone countries, Congo, Nigeria, Botswana, Malawi, Costa Rica, Vietnam, Philippines, Myanmar, Thailand, Sri Lanka, Nepal, Chile, Bnllvla, etc.

For rn o r e deta tls please visit Our web site www,stallionlabs.cem

TUNIC HEA.lTHCARE

128/A/l, Phase I & I:I:,G,1.0,e., Naroda, Ahmedabad - 382 330 India. Tel:+91·79·2754SS17 / +91·79·27545518 Fax: +91·79·27545817

E-rnall: infD@mediwinpharma.com,

patelbhavin68@gmail,com Website: www.mediwinpharma.com

Name of the delegate: Mr, Bhavin Arvindbhai Patel Designatio n: Pro pr i etor

Company Profile: Tunic Healthcare, a WHO - GM P CE RTIFIED Pharmaceuticals Form ulation CDm pany based at AHMEDABAD, GUJARAT, INDIA. Their entire plant is WHO·GMP certified. Their plant is equipped with latest rna chi neries and eq u i p men ts, They have t hei r own analytical laboratory. They manufacture varlous formulatlons like anti-bacterial, analgesics & antilnflarnrnatorv, anti-ulcers, anti-malarial, anti-fungal, Dermatological products, a ntt-hypertenstve, antldiabetics, antl-hlstarninlc, Anti allergic & anti cold, nutrient and vitamins in all available dosage forms. They are a more than 18 years old organization. They have their presence in almost all states of India, They export their products to' many countries.

details please visit Our web site

F. no, 201, H. No. 7-1-414/20&21, Koushik Sai Rama Residency, Srinivasa Nagar East, S. R. Nagar,

Hyderabad -500 038,lndia.

Tel, +91-40-23736533/ +91-40-23736558 Fax: +91-40·23733670

E·mail, irsekharrao@yahoo.co.in, admin@vancehealth.com Website: www.vancehealth.com

Name otlhe delegate: Mr.lmadabathuni Raina Sekhara Rao Designation: CMD

Company Profile: Vance & Health Pharmaceuticals Pvt. Ltd. established in 1999 is an ISO 9001-2008 a GMP ce rt i fied co rnpa ny. CR IS I L rated S E 1 B, e nga ged in man ufacturlng, marketing and exporting finished dosage forms. Vance & Health has 25 registered trademarks with 350 employees and rated as top 10% of the SMEs of the company. Vance & Health started its exports, in 2008 to St. Kitts and then to Dominican Rep u bl i c. Reg i stratlo n of prod u cts is in process in Dominican Republic and Trinidad & Tobago. Vance & Health will be setting up a WHO GMP unit in Hyderabad in 2010-11 to meet the growing exports from India.

Fo r more d eta i Is plea se vis ito ur webs ite www.vancehealth.com

VHB UFESCIENCES LTD.

T -351, 5th Floor, CBD Belapur Station Complex, Navi Mumbai - 400514, India.

Tel, +91-22-67739071

Fax: +91-22-67739100

E·mail, shankar.lyer@vhbgroup.com Website: www.vhbgroup.com

Name ofthe delegate: Mr.lyer Shankar Ramkrishnan Designation: Deputy General Manager -IntI. Mktg.

Company Profile: VHB Lifesciences Ltd. has its state of the plant designed as per the current GM P norms and approved by INVIMA Colombia & NOA Uganda. are manufacturers of pharmaceutical lnjectables ( I.e. Cardiology, 1m m unosuppressants, Cephalosporlns, Hormones, PFS etc).

For more details please visit Our web stte www.vhbgroup.com

957/4, G.I.O,c" Makarpura, Vadodara - 390 010, India,

Tel: +91-265-2644459/ +91-265-2534559 Fax: +91-265-2538171

E -rna i II: expo'rts@vasuhealthcare.com Website: www.vasuhealthcare.com

Name of the delegate: Mr. Mehta Nandit Ripunjay Designation.: Manager -tnternatronal Business

Com p a ny P rofl Ie: Va su Hea It h ca re Pvt. Ltd. is One of the leading manufacture and exporter of Herbal and Ayurvedic products from I ndia since 1980, They being India's ISO 9001, GMP and HACCP certified company into the specialty field of Ayurvedic Pharmaceuticals, Health Supplements, Raw Material/Extracts and Herbal Cosmetics. Their quality products are present in more than 20 countries.

For mo re deta i Is pie ase vis I t ou r web site www.vasuhealthcare.com. www.trichup.com. www.herbwnline.com

VHB MEDISCIENCES LTD.

T -351, Sth Floor, Tower No.8, CBO Belapur Station Complex, Navi Mumbai - 400 614, India,

Tel: +91-22-67739032 Fax: +91-22.-67739100

E-maill:arupputheraj.m@vhbgroup.com Website: www.vhbgroup.com

Name of the delegate: Mr, Manickam Arupputheraj Issac Designatio n: B D M - IntI. M ktg.

Com pany Profile: VH B M ed lscie nces Ltd. h as its state of the plant designed as per the current GMP norms and approved by INVIMA Colombia, & NDA Uganda are manufacturers of pharrnaceutlcal lnjectables [i.e. Oncology, Cephalcspnrlns, Hormones, P,FS etc),

For rn o r e de t alls please visit Our web site www.vhbgroup.com

WINTECH PHARMACEUTICALS

17, Broadway Shopping Center, Dr. Ambedkar Road, Dadar T.T., Dadar (E), Mumbai - 400 014, India.

Tel: +91-22-42123434/ +91-22-42123443/3455 Fax: +91-22-42123400

E-mail: sales@wintechpharma.com. sachin@wintechpharma.com, lenova2006@gmail.com Website: www.wintechpharma.com

Name of the delegate: Mr. Sachin Bhandari Designation: Export Manager

Com pany Profile: Wlntech Pharmaceuticals are a WHOGMP and 150-9000:2008 certified pharmaceuticals formulation manufacturing company engaged in manufacturing and marketing of pharmaceutical formulations in India and have 34 products COPP's for overseas markets. They have well equipped Tablet capsules & Liquid Oral Department under One roof. The products are manufactured under strict quality control and checked-in-house laboratory through latest instruments. They have a vision to serve man kind with the best med ication at affordable prices.

For more details please visit our web site www.wintechpharma.com

PHARMACEUTICALS EXPORT PROMOTION COUNCIL

(Set up by Ministry of Commerce &. lndustrv, Government of India)

101, Aditya Trade Centre, Ameerpet, Hyderabad - 500 038, India.

Tel: +91-40-2373 5462/66

Fax: +91-40-2373 5464

E-mail: info@pharmexcil.com Website: www.pharmexcil.com

T.V. Industrial Estate, Unit No. 211, 248-A,

S. K .. Ahire Marg. Worii, Mumbai - 400030. India. Tel: +91-22- 24938750/51

Fax:+91-22- 24938822

E-mail: romumbai@pharmexcil.com Website: www.pharmexcil.com

RAGHUVEER KINI

ADDL. EXECUTIVE DIRECTOR

DIPTI SALIAN EXECUTIVE