Industry Analysis: Indian Pharmaceutical IndustrySubmitted By:Abhishek(10810001)AnantDhingra(10810004)AnujMadaan(10810009)Maninder Pal Singh(10810029)Ravi PratapSingh(10810050)
AgendaIntroductionReason For Choosing Pharmaceutical IndustryPharmaceutical Industry- Age, History and OriginMarket Structure18Growth : Pharmaceutical Industry29Competition- Indian Pharmaceutical Industry310Export-Import: Pharmaceutical Industry411Effect of Foreign Investment512Effect of Foreign Investment6Government Regulation and Policies7Laws and Acts : Pharmaceutical IndustryTaxation SystemComparative Analysis of Pharmaceutical Industry in BRIC Nations13Future Outlook14
Introduction- Pharmaceutical Industry
The pharmaceutical industry in India is among the most highly organized sectors. This industry plays an important role in promoting and sustaining development in the field of global medicine. Due to the presence of low cost manufacturing facilities, educated and skilled manpower and cheap labor force among others, the industry is set to scale new heights in the fields of production, development, manufacturing and research. In 2008, the domestic pharma market in India was expected to be US$ 10.76 billion and this is likely to increase at a compound annual growth rate of 9.9 per cent until 2010 and subsequently at 9.5 per cent till the year 2015.Indian Pharmaceutical Industry
Indian Pharmaceutical IndustryIndian pharmaceutical industry has grown over a period of time and has seen many ups and down during its evolution.The architect of the Indian pharmaceutical industry would be AcharyaP.C.Ray. In the year 1901 AcharyaP.C.Ray founded Bengal Chemicals and Pharmaceuticals Works Ltd. It started by making drugs from indigenous materials and then went on to manufacture quality chemicals, drugs, pharmaceuticals and employed local technology, skills and resources.
Market SegmentsIndia is a fast-growing CMO and custom research outsourcing (CRO)  destination with a growth rate for CMO thrice the global market rateIndia’s manufacturing prowess in formulations is validated by the fact that it manufactures 60,000 packs across 60 therapy areasIndia is the third-largest player in the world with 500 different APIs
SWOT Analysis
Reason For Choosing Pharmaceutical Industry
Reason For Choosing Pharmaceutical IndustryDrugs and pharmaceutical industry plays a vital role in the economic development of a nation
India is one of the fastest-growing pharmaceutical markets in the world, and its market size has nearly doubled since 2005
The Indian pharmaceutical market is expected to reach US$ 20 billion by 2015, growing at a compound annual growth rate (CAGR) of 11.7 per cent during 2005–2015 and establish its presence among the world’s leading 10 markets
India is also the third-largest market in the world in terms of volume and fourteenth in terms of valueReason For Choosing Pharmaceutical Industry Contd…India accounts for 8 per cent of global pharmaceutical production. Indian firms produce about 60,000 generic brands across 60 therapeutic categories. In addition, Indian firms manufacture approximately 500 different active pharmaceutical ingredients (APIs)Moreover, according to an Ernst & Young and industry body study, the increasing population of the higher-income group in the country, will open a potential US$ 8 billion market for multinational companies selling costly drugs by 2015Further, IMS Health India, which tracks drug sales in the country through a network of nationwide drug distributors, estimates the healthcare market in India to reach US$ 31.59 billion by 2020
Pharmaceutical Industry- Age, History and Origin
Indian Pharmaceutical EvolutionPhase VInnovation and ResearchNew IP law
Discovery Research
ConvergencePhase IVGrowth PhaseRapid expansion of domestic market
International market development
Research orientationPhase III Development PhaseProcess development
Production  infrastructure creation
Export initiativesPhase IIGovernment ControlIndian Patent Act –1970
Drug prices capped
Local companies begin to make an impactPhase IEarly YearsMarket share domination by foreign companies
Relative absence of organized Indian companies19701980199020002010
Indian Pharmaceutical Evolution: Contd…
The pharma industry generally grows at about 1.5-1.6 times the Gross Domestic Product growthGlobally, India ranks third in terms of manufacturing pharma products by volumeThe Indian pharmaceutical industry is expected to grow at a rate of 9.9 % till 2010 and after that 9.5 % till 2015In 2007-08, India exported drugs worth US$7.2 billion in to the US and Europe followed by Central and Eastern Europe, Africa and Latin AmericaThe Indian vaccine market which was worth US$665 million in 2007-08 is growing at a rate of more than 20%The retail pharmaceutical market in India is expected to cross US$ 12-13 billion by 2012Industry Trends
Market Structure :Pharmaceutical Industry
Market StructureDivision of Industry
Market StructureIndian - Bulk Drugs & Formln M/S Market Share
Market StructureIndian - Bulk Drugs Market Share
Market StructureGelatin Capsules and I V Fluids Market Share
Market StructureIndian - Formulations Market Share
Market StructureMultinational Market Share
Indian - Bulk Drugs & FormlnLrgMarket Share
Growth : Pharmaceutical Industry
 Indian - Bulk Drugs & FormlnLrgSales Turnover(in Rs. Crore)Source: Capitalline
Indian - Bulk Drugs & FormlnLrgReported Net Profit(in Rs. Crore)Source: Capitalline
Competition in Indian Pharmaceutical IndustryAnalysis of major players
Indian - Bulk Drugs & FormlnLrgSales Turnover and Reported Net Profit on 2010 (in Rs. Crore)Source: CapitallineYour Logo
Indian - Bulk Drugs & FormlnLrgR&D Expenditure(in Rs. Crore) over 10 yearsSource: Capitalline
11 State-of-the-art manufacturing facilities in countries like India, Brazil, South AfricaProduct Portfolio caters to nutrition, infectious diseases, gastro-enteritis, pain management, cardiovascular ailments and central nervous system related ailments9 SBUs for various categories of drug manufactured by RanbaxyWell-known for highest R&D budget among pharma companies in the worldRanbaxy
Presence in more than 100 companiesDr. Reddy’s Laboratories is very much customer friendly and tries to meet medical needs of the people16 countries have the representative offices and 21 countries have third party distributionDr. Reddy’s Laboratories
Known as the manufacturer of specialty Active Pharmaceutical Ingredients and formulationsConcerned with chronic treatments such as cardiology, psychiatry, neurology, gastroenterology, diabetology and repiratory ailments.API include peptides, steroids, hormones, and anti-cancer drugs. Sun Pharmaceuticals
3 Major group companies:-Cacaco Pharmaceutical Laboratories (based in Detroit, Michigan)Sun Pharmaceuticals Industries Inc. (Michigan)Sun Pharmaceuticals (Bangladesh)Sun Pharmaceuticals
One of the most respected generic pharmaceuticals and API manufacturing company in the worldOperates in over 100 countriesOver 180 APIs, 250 formulations,110 DMFs and 90 ANDAsProduct segments involve- Antibiotics, Anti-Retro Virals, CVS,CNS, Anti-AllergicsAurobindoPharma
Export-Import: Pharmaceutical Industry
The government of India has undertaken several including policy initiatives and tax breaks for the growth of the pharmaceutical business in India. Some of the measures adopted are:Pharmaceutical units are eligible for weighted tax reduction at 150% for the research and development expenditure obtained.Two new schemes namely, New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Program have been launched by the Government.The Government is contemplating the creation of SRV or special purpose vehicles with an insurance cover to be used for funding new drug researchThe Department of Pharmaceuticals is mulling the creation of drug research facilities which can be used by private companies for research work on rentGovernment Initiatives
In the recent years, despite the slowdown witnessed in the global economy, exports from the pharmaceutical industry in India have shown good buoyancy in growth. Export has become an important driving force for growth in this industry with more than 50 % revenue coming from the overseas markets. For the financial year 2008-09 the export of drugs is estimated to be $8.25 billion as per the Pharmaceutical Export Council of India, which is an organization, set up by the Government of India. A survey undertaken by FICCI, the oldest industry chamber in India has predicted 16% growth in the export of India's pharmaceutical growth during 2009-2010.Pharma Export
Over 60 per cent of India’s bulk drug production is exported.Domestic pharmaceutical exports, growing at 30 per cent per annum, touched a new height of US$4.8 billion in the financial year 2006-07.The export revenue now contributes almost half of the total revenue for the top three pharmaceutical majors: Dr Reddy’s, Ranbaxy and Cipla.The other major exporters are Wockhardt Limited, Sun Pharmaceutical Industries Ltd. And Lupin Laboratories.The formulations and exports are largely to developing nations in CIS, South East Asia, Africa and Latin America .In the coming years, opening up of US generics market and anti  AIDS market in Africa will boost exports.Exports
Sales and Exports growth12
Exports of Top 8 Pharma Companies 10  Year  growth (year wise)
Import: Pharmaceutical products
Effect of Foreign Investment :  Pharmaceutical Industry
FDI by CountryThe largest source of FDI in Indian pharmaceutical industry is Mauritius. Many global investors in India route their FDI through Mauritius to take advantage of the India-Mauritius bilateral tax treaty.
Impact of Foreign Investment Major impact of foreign collaborations had been in the areas like Technological Developments---R&D & New Product Development, Productivity Enhancement, Reduction in Imports, Increase in Exports, Improvement in Quality Standards, Decrease in Net Foreign Exchange Outflow, Increase in Return on Capital Employed , Enhancing Marketing Base (Domestic & International) and overall Profitability.
Impact of Foreign Investment Indian drug industry has in the last five years seen half a dozen big takeovers by foreign companies.$3.6 billion acquisition of  promoters’ stake in Ranbaxy Laboratories in 2008 by Japan’s Daiichi Sankyo Co. Ltd.
 US drug maker Mylan Inc. paid $734 million to acquire Hyderabad-based Matrix Laboratories in 2006.
German health care group Fresenius SE spent $219 million to take over Dabur Pharma in 2008.Impact of Foreign Investment US drug and nutrition firm Abbott Laboratories paid $3.72 billion to acquire Piramal Healthcare Ltd’s domestic drug formulation business and spent $726 million to buy out Ahmedabad-based consumer health company Paras Pharmaceuticals.
 French drug multinational Sanofi-Aventis SA acquired a majority stake in Indian vaccines company Shanta Biotech in 2009 for €550 millionGovernment Regulation and Policies : Pharmaceutical Industry
India Patents Act,1972: Evolution and ImpactIndia provided product patent protection in pharmaceuticals till 1972This did not have any positive effect because:the MNCs, who held the patents were not keen on manufacturing (and R&D) activities;  they preferred imports to local production in India andprevented the Indian companies from doing so by using their  patent rights.On the one hand, because of lack of competition, drug prices in India were very high.On the other hand, India was dependent on imports for many of the essential bulk drugs. The import dependence constricted consumption in a country deficient in foreign exchange and inhibited the growth of the industry
The India Patents Act, 1970The 1970 Act imposed substantial limits on patent rights; these limits were intended to encourage indigenous inventions and secure their production in India on a commercial scale (India Patents Act 1970, § 83)
First, and most importantly, pharmaceutical products could not be patented
Second, firms were permitted to patent only a single process for making a pharmaceutical; a firm could not block competitors by patenting all possible processes for making a drug
Third, the term for pharmaceutical process patents shortened to five years from the grant of the patent or seven years from application filing, whichever was less, compared to 14 years from application filing for all other inventions
And fourth, the Act imposed very broad “compulsory licensing”provisions for  pharmaceutical process patents. Within three years of the grant, the patents were deemed “licenses of right,” meaning that anyone could use the  process  if  they   paid  a  royalty  (Chaudhuri  2005,  37-8).  In  sum, pharmaceutical  products had  no  protection,  and  pharmaceutical processes were protected for only three years if a royalty were paid and five years if no royalty were paidResultsRemarkable growth in the pharmaceutical industry in IndiaIndia and Japan: only two countries where western MNCs do not dominateIndia: net exporter and self sufficient in drugsDrug prices among the lowest in the worldSource of good quality cheap drugs for the rest of the worldIndia has the largest number of US FDA approved manufacturing facilities outside USAIt was not product patent protection but its abolition which operated as a pull mechanism in India by provided the Indian companies the space of operations and the opportunity to develop and innovateAided by the push programs of public investments in manufacturing and R&D, what Indian companies innovated are processes for manufacturing. And it is this capability which has permitted India to have an international presence and be a global source of drugs
Post-TRIPS Patent Laws (1995-Present)In  January of 1995, India  became a  founding member  of  the  World  Trade Organization (WTO) and agreed to the requirements of the WTO intellectual property  agreement,  Trade-Related  Aspects  of  Intellectual  Property  Rights (TRIPS).Under the Agreements on Trade Related Aspects of Intellectual Rights (TRIPS), mandatory for all countries to provide product patent protection in all products including pharmaceuticalsOne important argument during  TRIPS negotiationsDeveloping countries too would benefit from stronger patent protection because it will stimulate private R&D investment for developing country diseases e.g., leishmaniasis, sleeping sickness, Dengue fever, which are neglected by the Western MNCsTRIPS has not led to much R&D for developing drugs for necessary for developing countries and neglected by MNCs as Indian companies are not yet ready to undertake R&D independently and do not have all the skills and the resources to do so
Govt. Regulations and Legal AspectsGovt. Regulations and Legal Aspects … (1/4) The Central Drug Standard Control Organization (CDSCO), which falls under the purview of the Ministry of Health and Family Welfare, is the primary regulatory body in India. The Drug Controller General of India (DCGI) presides over the CDSCO and is in charge of the approval of licenses for drugs at both the central and state levels In January 2005, India introduced the product patent regime in accordance with the TRIPS agreement with an amendment to the Indian Patents Act. Further, in 2008, the introduction of the Drugs and Cosmetics (Amendment) Act 2008 put forth stringent penalties and imprisonment FDI of up to 100 per cent in drugs and pharmaceuticals is permitted through the automatic route. For licensable drugs and pharmaceuticals manufactured by recombinant DNA technology and specific cell/tissue-targeted formulations, FDI requires prior government approval
Govt. Regulations and Legal AspectsPolicy and regulatory framework … (2/4)The GoI plans to set up a pharmacopeial commission to support ayurveda, yoga and naturopathy, unani, siddha and homoeopathy (AYUSH) through guidelines laid down in the review of the Eleventh PlanAs stated on the National Pharmaceutical Pricing Authority (NPPA) website, the NPPA is responsible for fixing and controlling the prices of 76 bulk drugs under the Essential Commodities Act The Department of Pharmaceuticals was formed on July 2, 2008, under the Ministry of Chemicals and Fertilisers with the objective of focusing on the development of the pharmaceutical sector in the country and to regulate various activities related to the pricing and availability of medicines at affordable prices, R&D, the protection of intellectual property (IP) rights and international commitments related to the pharmaceutical sector The GoI has been actively supporting the industry with various measures. It is embarking on a major multi-billion dollar initiative, with 50 per cent public funding through a PPP model, to harness India’s innovation capability.
Govt. Regulations and Legal AspectsPolicy and regulatory framework … (3/4)
Govt. Regulations and Legal AspectsPolicy and regulatory framework … (4/4)Budget measures There has been an increase in weighted reduction from 150 to 200 per cent on expenditure incurred on in-house R&D activities and from 125 to 175 per cent on activities outsourced to specific institutions The Union Budget of 2010 permitted a partial rollback in excise duty from 8 to 10 per cent (to impact raw-material costs)Policy measures The DCGI has made the registration of all clinical trials compulsory for trials initiated after June 15, 2009. Previously, the registration of clinical trials by various institutions and companies was voluntaryThe DCGI has discontinued the issuance of the WHO-GMP certificate for both pharmaceutical products and plant auditsThe GoI has issued the draft Drugs and Cosmetics (4th Amendment) Rules, 2009, which provides for product licenses for narcotic drugs and psychotropic substances to be issued by the Central Licensing Approval Authority (CLAA), which were previously issued by state licensing authorities
State FDAs, on the other hand, monitor the drug manufacture, sale, and testing by companies in their jurisdiction. There are also two main statutory bodies formed by Parliament:    1) the Drugs Technical Advisory Board, whose technical experts advise the Central and State Governments on special technical matters involving drug regulation, and 2) the Drugs Consultative Committee, where Central and State drug officials ensure that drug control measures are enforced uniformly in all states.State Food and Drug Administrations (FDAs)
Laws and Acts : Pharmaceutical Industry
Laws Pertaining To Manufacture And Sale Of Drugs In IndiaThe Drugs and Cosmetics Act, 1940The Pharmacy Act, 1948The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954The Narcotic Drugs and Psychotropic Substances Act, 1985The Medicinal and Toilet Preparations (Excise Duties) Act, 1956The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act)
The object of the Act is to regulate the import, manufacture, distribution and sale of drugs.Under the provisions of this Act, the Central Government appoints the Drugs Technical Advisory Board to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act. The board can constitute subcommittees for the consideration of a particular matterThe Drugs and Cosmetics Act 1940
Under the provisions of this act the Central Government constitutes a Central Pharmacy Council of India consisting of following members:a) Six members from the Teachers of pharmacy.b) Six members from practicing pharmacists or Pharmaceutical Chemists holding degree of diploma.c) One member elected by the Medical Council of India.d) The Director-General of Health Services.e) The Director of the Central Drugs Laboratory.f) The Chief Chemist, Central Revenues.g) One member to represent each state elected by members of State Councils who shall be a registered pharmacist.h) One member to represent each State Government who shall be either registered medical practitioner or a registered pharmacist.The Pharmacy Act 1948
The State Government has under the provisions of the Pharmacy Act to get a register of the State Pharmacists prepared and it is the State Pharmacy Council which has to maintain the register. The register shall contain the name and residential address of Pharmacist, the date of his first admission to the register, qualifications for registration, his professional address, the name of his employer and prescribed particularsRegistration of Pharmacists
This Act is meant to control the Advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities and to provide for matters connected therewith.The Drugs and Magic Remedies Act prohibits a person from taking part in publication of any advertisement referring to any drug which suggests use of the drug for:a) the procurement of miscarriage in women or prevention of conception in women; andb) the maintenance or improvement of the capacity of the human being for sexual pleasure;The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
This is an Act to consolidate and amend the law relating to Narcotic DrugsIt’s aim is to make stringent provisions for the control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances and for matters connected therewithNarcotic Drugs and Psychotropic Substances Act, 1985
Taxation System: Pharmaceutical Industry
Governed by the provisions of Income-tax Act, 1961Under the provisions of section 35(1) of the Act, a deduction of 100 percent expenditure, not being expenditure in the nature of cost of any land and building is available in respect to scientific research related to the businessExpenditure on developing the SEZ is exempt from all duties of customs, excise, CST and service tax.'Tax'ing Indian PharmaDirect taxes
Customs duty consists of Basic Customs Duty (BCD)-12.5 percentAdditional duty of customs under section 3(1) ('CVD')-16.32 percent and additional duty of customs under section 3(5) (ADC)-four percentExcise duty is levied at 16 percent on the transaction value of goods manufactured in IndiaDrugs and medicines classified under chapter heading 3003.10 and 3003.20 are subject to excise duty on the basis of the MRP'Tax'ing Indian PharmaIndirect taxes
11 states have introduced a system of levying tax on MRP at a single point ie first sale in the state is subject to VAT on the basis of MRP and subsequent salesCST rate is four percent against furnishing of prescribed declarations. Otherwise, the rate of tax is 10 percent or the VAT rate prevailing in the originating state, whichever is higherRate of service tax is 12 percent, together with education cess at two percent i.e. 12.24 percent.'Tax'ing Indian PharmaIndirect taxes
India is perceived as an attractive destination to outsource R&D work and contract manufacturingThe only tax benefit available for Research & Development activities for such companies is the weighted deductionCompanies engaged in R & D activity do not get weighted deduction in respect of expenditure not approved by DSIR though the R & D facility is an approved one. So government to need to clarify existing provisions Issues with Taxation SystemIndian - Bulk Drugs & FormlnLrg
Customs duty on import on Life saving drugs and medical servicesRationalization of custom duty for formulations SAD (Special Additional Duty) refunds are taking more than a year to get processing the refund and the processes involved are cumbersomeGovernment should reduce custom duty on all Life Saving medical devices to 5% Issues with Taxation SystemIndian - Bulk Drugs & FormlnLrg

Pharma industry 1-4_9_29_50

  • 1.
    Industry Analysis: IndianPharmaceutical IndustrySubmitted By:Abhishek(10810001)AnantDhingra(10810004)AnujMadaan(10810009)Maninder Pal Singh(10810029)Ravi PratapSingh(10810050)
  • 2.
    AgendaIntroductionReason For ChoosingPharmaceutical IndustryPharmaceutical Industry- Age, History and OriginMarket Structure18Growth : Pharmaceutical Industry29Competition- Indian Pharmaceutical Industry310Export-Import: Pharmaceutical Industry411Effect of Foreign Investment512Effect of Foreign Investment6Government Regulation and Policies7Laws and Acts : Pharmaceutical IndustryTaxation SystemComparative Analysis of Pharmaceutical Industry in BRIC Nations13Future Outlook14
  • 3.
  • 4.
    The pharmaceutical industryin India is among the most highly organized sectors. This industry plays an important role in promoting and sustaining development in the field of global medicine. Due to the presence of low cost manufacturing facilities, educated and skilled manpower and cheap labor force among others, the industry is set to scale new heights in the fields of production, development, manufacturing and research. In 2008, the domestic pharma market in India was expected to be US$ 10.76 billion and this is likely to increase at a compound annual growth rate of 9.9 per cent until 2010 and subsequently at 9.5 per cent till the year 2015.Indian Pharmaceutical Industry
  • 5.
    Indian Pharmaceutical IndustryIndianpharmaceutical industry has grown over a period of time and has seen many ups and down during its evolution.The architect of the Indian pharmaceutical industry would be AcharyaP.C.Ray. In the year 1901 AcharyaP.C.Ray founded Bengal Chemicals and Pharmaceuticals Works Ltd. It started by making drugs from indigenous materials and then went on to manufacture quality chemicals, drugs, pharmaceuticals and employed local technology, skills and resources.
  • 7.
    Market SegmentsIndia isa fast-growing CMO and custom research outsourcing (CRO) destination with a growth rate for CMO thrice the global market rateIndia’s manufacturing prowess in formulations is validated by the fact that it manufactures 60,000 packs across 60 therapy areasIndia is the third-largest player in the world with 500 different APIs
  • 8.
  • 9.
    Reason For ChoosingPharmaceutical Industry
  • 10.
    Reason For ChoosingPharmaceutical IndustryDrugs and pharmaceutical industry plays a vital role in the economic development of a nation
  • 11.
    India is oneof the fastest-growing pharmaceutical markets in the world, and its market size has nearly doubled since 2005
  • 12.
    The Indian pharmaceuticalmarket is expected to reach US$ 20 billion by 2015, growing at a compound annual growth rate (CAGR) of 11.7 per cent during 2005–2015 and establish its presence among the world’s leading 10 markets
  • 13.
    India is alsothe third-largest market in the world in terms of volume and fourteenth in terms of valueReason For Choosing Pharmaceutical Industry Contd…India accounts for 8 per cent of global pharmaceutical production. Indian firms produce about 60,000 generic brands across 60 therapeutic categories. In addition, Indian firms manufacture approximately 500 different active pharmaceutical ingredients (APIs)Moreover, according to an Ernst & Young and industry body study, the increasing population of the higher-income group in the country, will open a potential US$ 8 billion market for multinational companies selling costly drugs by 2015Further, IMS Health India, which tracks drug sales in the country through a network of nationwide drug distributors, estimates the healthcare market in India to reach US$ 31.59 billion by 2020
  • 14.
  • 15.
    Indian Pharmaceutical EvolutionPhaseVInnovation and ResearchNew IP law
  • 16.
  • 17.
    ConvergencePhase IVGrowth PhaseRapidexpansion of domestic market
  • 18.
  • 19.
    Research orientationPhase IIIDevelopment PhaseProcess development
  • 20.
  • 21.
    Export initiativesPhase IIGovernmentControlIndian Patent Act –1970
  • 22.
  • 23.
    Local companies beginto make an impactPhase IEarly YearsMarket share domination by foreign companies
  • 24.
    Relative absence oforganized Indian companies19701980199020002010
  • 25.
  • 26.
    The pharma industrygenerally grows at about 1.5-1.6 times the Gross Domestic Product growthGlobally, India ranks third in terms of manufacturing pharma products by volumeThe Indian pharmaceutical industry is expected to grow at a rate of 9.9 % till 2010 and after that 9.5 % till 2015In 2007-08, India exported drugs worth US$7.2 billion in to the US and Europe followed by Central and Eastern Europe, Africa and Latin AmericaThe Indian vaccine market which was worth US$665 million in 2007-08 is growing at a rate of more than 20%The retail pharmaceutical market in India is expected to cross US$ 12-13 billion by 2012Industry Trends
  • 27.
  • 28.
  • 29.
    Market StructureIndian -Bulk Drugs & Formln M/S Market Share
  • 30.
    Market StructureIndian -Bulk Drugs Market Share
  • 31.
    Market StructureGelatin Capsulesand I V Fluids Market Share
  • 32.
    Market StructureIndian -Formulations Market Share
  • 33.
  • 34.
    Indian - BulkDrugs & FormlnLrgMarket Share
  • 35.
  • 36.
    Indian -Bulk Drugs & FormlnLrgSales Turnover(in Rs. Crore)Source: Capitalline
  • 37.
    Indian - BulkDrugs & FormlnLrgReported Net Profit(in Rs. Crore)Source: Capitalline
  • 38.
    Competition in IndianPharmaceutical IndustryAnalysis of major players
  • 39.
    Indian - BulkDrugs & FormlnLrgSales Turnover and Reported Net Profit on 2010 (in Rs. Crore)Source: CapitallineYour Logo
  • 40.
    Indian - BulkDrugs & FormlnLrgR&D Expenditure(in Rs. Crore) over 10 yearsSource: Capitalline
  • 41.
    11 State-of-the-art manufacturingfacilities in countries like India, Brazil, South AfricaProduct Portfolio caters to nutrition, infectious diseases, gastro-enteritis, pain management, cardiovascular ailments and central nervous system related ailments9 SBUs for various categories of drug manufactured by RanbaxyWell-known for highest R&D budget among pharma companies in the worldRanbaxy
  • 42.
    Presence in morethan 100 companiesDr. Reddy’s Laboratories is very much customer friendly and tries to meet medical needs of the people16 countries have the representative offices and 21 countries have third party distributionDr. Reddy’s Laboratories
  • 43.
    Known as themanufacturer of specialty Active Pharmaceutical Ingredients and formulationsConcerned with chronic treatments such as cardiology, psychiatry, neurology, gastroenterology, diabetology and repiratory ailments.API include peptides, steroids, hormones, and anti-cancer drugs. Sun Pharmaceuticals
  • 44.
    3 Major groupcompanies:-Cacaco Pharmaceutical Laboratories (based in Detroit, Michigan)Sun Pharmaceuticals Industries Inc. (Michigan)Sun Pharmaceuticals (Bangladesh)Sun Pharmaceuticals
  • 45.
    One of themost respected generic pharmaceuticals and API manufacturing company in the worldOperates in over 100 countriesOver 180 APIs, 250 formulations,110 DMFs and 90 ANDAsProduct segments involve- Antibiotics, Anti-Retro Virals, CVS,CNS, Anti-AllergicsAurobindoPharma
  • 46.
  • 47.
    The government ofIndia has undertaken several including policy initiatives and tax breaks for the growth of the pharmaceutical business in India. Some of the measures adopted are:Pharmaceutical units are eligible for weighted tax reduction at 150% for the research and development expenditure obtained.Two new schemes namely, New Millennium Indian Technology Leadership Initiative and the Drugs and Pharmaceuticals Research Program have been launched by the Government.The Government is contemplating the creation of SRV or special purpose vehicles with an insurance cover to be used for funding new drug researchThe Department of Pharmaceuticals is mulling the creation of drug research facilities which can be used by private companies for research work on rentGovernment Initiatives
  • 48.
    In the recentyears, despite the slowdown witnessed in the global economy, exports from the pharmaceutical industry in India have shown good buoyancy in growth. Export has become an important driving force for growth in this industry with more than 50 % revenue coming from the overseas markets. For the financial year 2008-09 the export of drugs is estimated to be $8.25 billion as per the Pharmaceutical Export Council of India, which is an organization, set up by the Government of India. A survey undertaken by FICCI, the oldest industry chamber in India has predicted 16% growth in the export of India's pharmaceutical growth during 2009-2010.Pharma Export
  • 49.
    Over 60 percent of India’s bulk drug production is exported.Domestic pharmaceutical exports, growing at 30 per cent per annum, touched a new height of US$4.8 billion in the financial year 2006-07.The export revenue now contributes almost half of the total revenue for the top three pharmaceutical majors: Dr Reddy’s, Ranbaxy and Cipla.The other major exporters are Wockhardt Limited, Sun Pharmaceutical Industries Ltd. And Lupin Laboratories.The formulations and exports are largely to developing nations in CIS, South East Asia, Africa and Latin America .In the coming years, opening up of US generics market and anti AIDS market in Africa will boost exports.Exports
  • 50.
  • 51.
    Exports of Top8 Pharma Companies 10 Year growth (year wise)
  • 52.
  • 53.
    Effect of ForeignInvestment : Pharmaceutical Industry
  • 54.
    FDI by CountryThelargest source of FDI in Indian pharmaceutical industry is Mauritius. Many global investors in India route their FDI through Mauritius to take advantage of the India-Mauritius bilateral tax treaty.
  • 55.
    Impact of ForeignInvestment Major impact of foreign collaborations had been in the areas like Technological Developments---R&D & New Product Development, Productivity Enhancement, Reduction in Imports, Increase in Exports, Improvement in Quality Standards, Decrease in Net Foreign Exchange Outflow, Increase in Return on Capital Employed , Enhancing Marketing Base (Domestic & International) and overall Profitability.
  • 56.
    Impact of ForeignInvestment Indian drug industry has in the last five years seen half a dozen big takeovers by foreign companies.$3.6 billion acquisition of promoters’ stake in Ranbaxy Laboratories in 2008 by Japan’s Daiichi Sankyo Co. Ltd.
  • 57.
    US drugmaker Mylan Inc. paid $734 million to acquire Hyderabad-based Matrix Laboratories in 2006.
  • 58.
    German health caregroup Fresenius SE spent $219 million to take over Dabur Pharma in 2008.Impact of Foreign Investment US drug and nutrition firm Abbott Laboratories paid $3.72 billion to acquire Piramal Healthcare Ltd’s domestic drug formulation business and spent $726 million to buy out Ahmedabad-based consumer health company Paras Pharmaceuticals.
  • 59.
    French drugmultinational Sanofi-Aventis SA acquired a majority stake in Indian vaccines company Shanta Biotech in 2009 for €550 millionGovernment Regulation and Policies : Pharmaceutical Industry
  • 60.
    India Patents Act,1972:Evolution and ImpactIndia provided product patent protection in pharmaceuticals till 1972This did not have any positive effect because:the MNCs, who held the patents were not keen on manufacturing (and R&D) activities; they preferred imports to local production in India andprevented the Indian companies from doing so by using their patent rights.On the one hand, because of lack of competition, drug prices in India were very high.On the other hand, India was dependent on imports for many of the essential bulk drugs. The import dependence constricted consumption in a country deficient in foreign exchange and inhibited the growth of the industry
  • 61.
    The India PatentsAct, 1970The 1970 Act imposed substantial limits on patent rights; these limits were intended to encourage indigenous inventions and secure their production in India on a commercial scale (India Patents Act 1970, § 83)
  • 62.
    First, and mostimportantly, pharmaceutical products could not be patented
  • 63.
    Second, firms werepermitted to patent only a single process for making a pharmaceutical; a firm could not block competitors by patenting all possible processes for making a drug
  • 64.
    Third, the termfor pharmaceutical process patents shortened to five years from the grant of the patent or seven years from application filing, whichever was less, compared to 14 years from application filing for all other inventions
  • 65.
    And fourth, theAct imposed very broad “compulsory licensing”provisions for pharmaceutical process patents. Within three years of the grant, the patents were deemed “licenses of right,” meaning that anyone could use the process if they paid a royalty (Chaudhuri 2005, 37-8). In sum, pharmaceutical products had no protection, and pharmaceutical processes were protected for only three years if a royalty were paid and five years if no royalty were paidResultsRemarkable growth in the pharmaceutical industry in IndiaIndia and Japan: only two countries where western MNCs do not dominateIndia: net exporter and self sufficient in drugsDrug prices among the lowest in the worldSource of good quality cheap drugs for the rest of the worldIndia has the largest number of US FDA approved manufacturing facilities outside USAIt was not product patent protection but its abolition which operated as a pull mechanism in India by provided the Indian companies the space of operations and the opportunity to develop and innovateAided by the push programs of public investments in manufacturing and R&D, what Indian companies innovated are processes for manufacturing. And it is this capability which has permitted India to have an international presence and be a global source of drugs
  • 66.
    Post-TRIPS Patent Laws(1995-Present)In January of 1995, India became a founding member of the World Trade Organization (WTO) and agreed to the requirements of the WTO intellectual property agreement, Trade-Related Aspects of Intellectual Property Rights (TRIPS).Under the Agreements on Trade Related Aspects of Intellectual Rights (TRIPS), mandatory for all countries to provide product patent protection in all products including pharmaceuticalsOne important argument during TRIPS negotiationsDeveloping countries too would benefit from stronger patent protection because it will stimulate private R&D investment for developing country diseases e.g., leishmaniasis, sleeping sickness, Dengue fever, which are neglected by the Western MNCsTRIPS has not led to much R&D for developing drugs for necessary for developing countries and neglected by MNCs as Indian companies are not yet ready to undertake R&D independently and do not have all the skills and the resources to do so
  • 67.
    Govt. Regulations andLegal AspectsGovt. Regulations and Legal Aspects … (1/4) The Central Drug Standard Control Organization (CDSCO), which falls under the purview of the Ministry of Health and Family Welfare, is the primary regulatory body in India. The Drug Controller General of India (DCGI) presides over the CDSCO and is in charge of the approval of licenses for drugs at both the central and state levels In January 2005, India introduced the product patent regime in accordance with the TRIPS agreement with an amendment to the Indian Patents Act. Further, in 2008, the introduction of the Drugs and Cosmetics (Amendment) Act 2008 put forth stringent penalties and imprisonment FDI of up to 100 per cent in drugs and pharmaceuticals is permitted through the automatic route. For licensable drugs and pharmaceuticals manufactured by recombinant DNA technology and specific cell/tissue-targeted formulations, FDI requires prior government approval
  • 68.
    Govt. Regulations andLegal AspectsPolicy and regulatory framework … (2/4)The GoI plans to set up a pharmacopeial commission to support ayurveda, yoga and naturopathy, unani, siddha and homoeopathy (AYUSH) through guidelines laid down in the review of the Eleventh PlanAs stated on the National Pharmaceutical Pricing Authority (NPPA) website, the NPPA is responsible for fixing and controlling the prices of 76 bulk drugs under the Essential Commodities Act The Department of Pharmaceuticals was formed on July 2, 2008, under the Ministry of Chemicals and Fertilisers with the objective of focusing on the development of the pharmaceutical sector in the country and to regulate various activities related to the pricing and availability of medicines at affordable prices, R&D, the protection of intellectual property (IP) rights and international commitments related to the pharmaceutical sector The GoI has been actively supporting the industry with various measures. It is embarking on a major multi-billion dollar initiative, with 50 per cent public funding through a PPP model, to harness India’s innovation capability.
  • 69.
    Govt. Regulations andLegal AspectsPolicy and regulatory framework … (3/4)
  • 70.
    Govt. Regulations andLegal AspectsPolicy and regulatory framework … (4/4)Budget measures There has been an increase in weighted reduction from 150 to 200 per cent on expenditure incurred on in-house R&D activities and from 125 to 175 per cent on activities outsourced to specific institutions The Union Budget of 2010 permitted a partial rollback in excise duty from 8 to 10 per cent (to impact raw-material costs)Policy measures The DCGI has made the registration of all clinical trials compulsory for trials initiated after June 15, 2009. Previously, the registration of clinical trials by various institutions and companies was voluntaryThe DCGI has discontinued the issuance of the WHO-GMP certificate for both pharmaceutical products and plant auditsThe GoI has issued the draft Drugs and Cosmetics (4th Amendment) Rules, 2009, which provides for product licenses for narcotic drugs and psychotropic substances to be issued by the Central Licensing Approval Authority (CLAA), which were previously issued by state licensing authorities
  • 71.
    State FDAs, onthe other hand, monitor the drug manufacture, sale, and testing by companies in their jurisdiction. There are also two main statutory bodies formed by Parliament: 1) the Drugs Technical Advisory Board, whose technical experts advise the Central and State Governments on special technical matters involving drug regulation, and 2) the Drugs Consultative Committee, where Central and State drug officials ensure that drug control measures are enforced uniformly in all states.State Food and Drug Administrations (FDAs)
  • 72.
    Laws and Acts: Pharmaceutical Industry
  • 73.
    Laws Pertaining ToManufacture And Sale Of Drugs In IndiaThe Drugs and Cosmetics Act, 1940The Pharmacy Act, 1948The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954The Narcotic Drugs and Psychotropic Substances Act, 1985The Medicinal and Toilet Preparations (Excise Duties) Act, 1956The Drugs (Prices Control) Order 1995 (under the Essential Commodities Act)
  • 74.
    The object ofthe Act is to regulate the import, manufacture, distribution and sale of drugs.Under the provisions of this Act, the Central Government appoints the Drugs Technical Advisory Board to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act. The board can constitute subcommittees for the consideration of a particular matterThe Drugs and Cosmetics Act 1940
  • 75.
    Under the provisionsof this act the Central Government constitutes a Central Pharmacy Council of India consisting of following members:a) Six members from the Teachers of pharmacy.b) Six members from practicing pharmacists or Pharmaceutical Chemists holding degree of diploma.c) One member elected by the Medical Council of India.d) The Director-General of Health Services.e) The Director of the Central Drugs Laboratory.f) The Chief Chemist, Central Revenues.g) One member to represent each state elected by members of State Councils who shall be a registered pharmacist.h) One member to represent each State Government who shall be either registered medical practitioner or a registered pharmacist.The Pharmacy Act 1948
  • 76.
    The State Governmenthas under the provisions of the Pharmacy Act to get a register of the State Pharmacists prepared and it is the State Pharmacy Council which has to maintain the register. The register shall contain the name and residential address of Pharmacist, the date of his first admission to the register, qualifications for registration, his professional address, the name of his employer and prescribed particularsRegistration of Pharmacists
  • 77.
    This Act ismeant to control the Advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities and to provide for matters connected therewith.The Drugs and Magic Remedies Act prohibits a person from taking part in publication of any advertisement referring to any drug which suggests use of the drug for:a) the procurement of miscarriage in women or prevention of conception in women; andb) the maintenance or improvement of the capacity of the human being for sexual pleasure;The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
  • 78.
    This is anAct to consolidate and amend the law relating to Narcotic DrugsIt’s aim is to make stringent provisions for the control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances and for matters connected therewithNarcotic Drugs and Psychotropic Substances Act, 1985
  • 79.
  • 80.
    Governed by theprovisions of Income-tax Act, 1961Under the provisions of section 35(1) of the Act, a deduction of 100 percent expenditure, not being expenditure in the nature of cost of any land and building is available in respect to scientific research related to the businessExpenditure on developing the SEZ is exempt from all duties of customs, excise, CST and service tax.'Tax'ing Indian PharmaDirect taxes
  • 81.
    Customs duty consistsof Basic Customs Duty (BCD)-12.5 percentAdditional duty of customs under section 3(1) ('CVD')-16.32 percent and additional duty of customs under section 3(5) (ADC)-four percentExcise duty is levied at 16 percent on the transaction value of goods manufactured in IndiaDrugs and medicines classified under chapter heading 3003.10 and 3003.20 are subject to excise duty on the basis of the MRP'Tax'ing Indian PharmaIndirect taxes
  • 82.
    11 states haveintroduced a system of levying tax on MRP at a single point ie first sale in the state is subject to VAT on the basis of MRP and subsequent salesCST rate is four percent against furnishing of prescribed declarations. Otherwise, the rate of tax is 10 percent or the VAT rate prevailing in the originating state, whichever is higherRate of service tax is 12 percent, together with education cess at two percent i.e. 12.24 percent.'Tax'ing Indian PharmaIndirect taxes
  • 83.
    India is perceivedas an attractive destination to outsource R&D work and contract manufacturingThe only tax benefit available for Research & Development activities for such companies is the weighted deductionCompanies engaged in R & D activity do not get weighted deduction in respect of expenditure not approved by DSIR though the R & D facility is an approved one. So government to need to clarify existing provisions Issues with Taxation SystemIndian - Bulk Drugs & FormlnLrg
  • 84.
    Customs duty onimport on Life saving drugs and medical servicesRationalization of custom duty for formulations SAD (Special Additional Duty) refunds are taking more than a year to get processing the refund and the processes involved are cumbersomeGovernment should reduce custom duty on all Life Saving medical devices to 5% Issues with Taxation SystemIndian - Bulk Drugs & FormlnLrg
  • 85.
    Physician samples shouldbe exempted from payment of Excise DutyAs per the section 4A of the Central Excise Act, 1944, an abatement of 35% allowed for the purpose of levying Excise Duty on PharmaceuticalsThe excise duty rate of APIs should be reduced from 10% to 4%, so as to make it at par with formulations Issues with Taxation SystemIndian - Bulk Drugs & FormlnLrg
  • 86.
    Issues with TaxationSystemDifferent VAT rates for pharma goods in different states / different description in schedule entries related to life saving drugs/ medical equipmentTransaction costs are increasing to the dealers, as the definition of goods in section 8(3) not permitting them cover all goodsThe tax rate of 4-5% on medicines and the list of tax-exempt goods and declared goods should be uniform across all states. Specifically, Life saving drugs and life saving medical equipment should be included in exempt goods or zero rate of percent VAT categoryIndian - Bulk Drugs & FormlnLrg
  • 87.
    Provisions of thecredit rules do not permit the Brand Owner to avail the credit if it is the not the manufacturer of the finished goods. Even the job worker cannot avail the credit as he does not pay for the input service. Further, the corresponding invoices of services are not in their name and said services not directly received by them.There exists a confusion and litigation as the State Governments are still levying sales tax on supply of software, where as the definition of sale in few state VAT legislations includes right to use.Issues with Taxation SystemIndian - Bulk Drugs & FormlnLrg
  • 88.
    Transfer Pricing istreated as concealment of income and harsh penalties of 100-300% are levied.Scheduled formulations on which price control is applicable through a maximum permissible prescribed mark-up on the transfer price, downward adjustment due to transfer pricing regulations would affect established end selling.Issues with Taxation SystemIndian - Bulk Drugs & FormlnLrg
  • 89.
    The likely implementationof GST will be closely watched by the pharmaceutical industry as the total tax rate might go up, if the GST rates are not fixed in line with current indirect tax incidence. Further, there can be excise and customs duty concessions on a few more drugs in life saving list.Future expectations
  • 90.
    Comparative Analysis ofPharmaceutical Industry in BRIC Nations
  • 91.
    Comparison with emergingeconomies China and Brazil2015 Projected Figures2005 Figures. Market SizeMarket SizeRank Country Market size5. China USD 38 bn11. Brazil USD 20 bn10. India USD 20 bnRank Country Market size9. China USD 13 bn11. Brazil USD 9 bn14. India USD 6 bn
  • 92.
    Comparison with emergingeconomies China and BrazilChina IndiaBrazilPatent protection started in 1990s but strictly regulated from 2005Share of Patent protected drugs is 5% in total marketShare of MNCs in total market is 25-30%patent protection started since 1994 and is strictly in line with countries like US.Share of patent protected drugs is 15% in total market.Share of MNCs in total market is 65-70%.Patent Protection started from 2005.Share of patent protected drugs is 9% in total market.Share of MNCs in the total market is almost 24%111222333
  • 93.
    Future Outlook :Pharmaceutical Industry
  • 94.
    With severalcompanies slated to make investments in India, the future scenario of the pharmaceutical industry in looks pretty promising. The country's pharmaceutical industry has tremendous potential of growth considering all the projects that are in the pipeline. Some of the future initiatives are:According to a study by FICCI-Ernst & Young India will open a probable US$ 8 billion market for MNCs selling expensive drugs by 2015The study also says that the domestic pharma market is likely to reach US$ 20 billion by 2015The Minister of Commerce estimates that US$ 6.31 billion will be invested in the domestic pharmaceutical sectorFuture Scenario
  • 95.
    Public spending onhealthcare is likely to raise from 7 per cent of GDP in 2007 to 13 per cent of GDP by 2015Dr Reddy's Laboratories has tied up with GlaxoSmithKline to develop and market generics and formulations in upcoming markets overseasLupin, a Mumbai based pharmaceutical company is looking to tap opportunities of about US$ 200 million in the US oral contraceptives marketDue to the low cost of R&D, the Indian pharmaceutical off-shoring industry is designated to turn out to be a US$ 2.5 billion opportunity by 2012Future Scenario
  • 96.
  • 97.
    Responsibilities and Resourceswould make an important beginning in the transition ofefficient and effective use of pharmaceutical in building a prosperous and healthy India.In doing so, following issues have been identified for realizing the Pharma Vision 2020.• The Indian pharmaceutical industry shall ensure that essential drugs at affordableprices are available to the vast population of this sub-continent and also continueproviding employment for millions.• India will emerge as a major global player in the field of pharmaceuticals exports andas a provider of quality medicines at low costs. It shall also emerge as a major playerin the generic drugs market in USA and Europe.Vision 2020
  • 98.
    • India willemerge as a major global player in the field of pharmaceuticals exports andas a provider of quality medicines at low costs. It shall also emerge as a major playerin the generic drugs market in USA and Europe.• India shall attain new heights in herbal drugs research in shaping Indian Systems ofMedicine into a popular system of medicine of the future for holistic health care andensuring health care for all - especially for the welfare of the poor.• India’s Patents Act should ensure that it does not exceed the requirements of TRIPS,and that prioritizes access to medicines and public health, while retaining the rightto participate in the compulsory license scenario. India should lead a movement ofdevelopingVision 2020
  • 99.