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Pharma overview
 

Pharma overview

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    Pharma overview Pharma overview Document Transcript

    • The Indian Pharmaceutical Industry currently tops the chart amongst India s science-basedindustries with wide ranging capabilities in the complex field of drug manufacture andtechnology. The Indian Pharmaceutical Industry ranks very high amongst all third worldcountries, in terms of technology, quality and the vast range of medicines that are manufactured.The Pharmaceutical industry has grown from mere US$ 0.3 billion turnover in 1980 to aboutUS$ 21.73 billion in 2009-10. The country now ranks 3 rd in terms of volume of production (10per cent of global share) an 14 th largest by value (1.5 per cent of global share). One reason forlower value share is the lowest cost of drugs in India ranging from 5 per cent to 50 per cent lessas compared to developed countries. Indian pharmaceutical industry growth has been fuelled byexports and its products are exported to a large number of countries with a sizeable share in theadvanced regulated markets of the US and Western Europe .Many Indian companies maintain highest standards in Purity, Stability and International Safety,Health and Environmental (SHE) protection in production and supply of bulk drugs even to someinnovator companies. This speaks of the high quality standards maintained by a large number ofIndian Pharma companies as these bulk actives are used by the buyer companies in manufactureof dosage forms which are again subjected to stringent assessment by various regulatoryauthorities in the importing countries. More of Indian companies are now seeking regulatoryapprovals in USA in specialized segments like Anti-infectives, Cardiovasculars, CNS group.Along with Brazil & PR China, India has carved a niche for itself by being a top generic Pharmaplayer.Increasing number of Indian pharmaceutical companies have been getting internationalregulatory approvals for their plants from agencies like USFDA (USA), MHRA (UK), TGA(Australia), MCC (South Africa), Health Canada etc. India has the largest number of USFDA-approved plants for generic manufacture. Considering that the pharmaceutical industry involvessophisticated technology and stringent "Good Manufacturing Practice (GMP) requirements,major share of Indian Pharma exports going to highly developed western countries bearstestimony to not only the excellent quality of Indian pharmaceuticals but also its pricecompetitiveness. More than 50 per cent share of exports is by way of dosage forms. Indiancompanies are now seeking more Abbreviated New Drug Approvals (ANDAs) in USA inspecialized segments like anti-infective, cardio vascular and central nervous system groups.ExportsIndia currently exports drug intermediates, Active Pharmaceutical Ingredients (APIs), FinishedDosage Formulations (FDFs), Bio-Pharmaceuticals, Clinical Services to various parts of theworld.Export of Drugs and pharmaceuticals from 2007-08 to 2009-10 are given below:he domestic Pharma IndustryThe domestic Pharma Industry has recently achieved some historic milestones through aleadership position and global presence as a world class cost effective generic drugs
    • manufacturer of AIDS medicines. Many Indian companies are part of an agreement where majorAIDS drugs based on Lamivudine, Stavudine, Zidovudine, Nevirapine will be supplied toMozambique, Rwanda, South Africa and Tanzania which have about 33 per cent of all peopleliving with AIDS in Africa. Yet another US Scheme envisages sourcing Anti Retrovirals fromsome Indian companies whose products are already US FDA approved.Many Indian companies maintain highest standards in Purity, Stability and International Safety,Health and Environmental (SHE) protection in production and supply of bulk drugs even to someinnovator companies. This speaks of the high quality standards maintained by a large number ofIndian Pharma companies as these bulk actives are used by the buyer companies in manufactureof dosage forms which are again subjected to stringent assessment by various regulatoryauthorities in the importing countries. More of Indian companies are now seeking regulatoryapprovals in USA in specialized segments like Anti-infectives, Cardiovasculars, CNS group.Along with Brazil & PR China, India has carved a niche for itself by being a top generic Pharmaplayer.Increasing number of Indian pharmaceutical companies have been getting internationalregulatory approvals for their plants from agencies like USFDA (USA), MHRA (UK), TGA(Australia), MCC (South Africa), Health Canada etc. India has the largest number of USFDA -approved plants for generic manufacture. Considering that the pharmaceutical industry involvessophisticated technology and stringent "Good Manufacturing Practice (GMP) requirements,major share of Indian Pharma exports going to highly developed western countries bearstestimony to not only the excellent quality of Indian pharmaceuticals but also its pricecompetitiveness. More than 50 per cent share of exports is by way of dosage forms. Indiancompanies are now seeking more Abbreviated New Drug Approvals (ANDAs) in USA inspecialized segments like anti-infective, cardio vascular and central nervous system groups.INDUSTRY & SERVICESGovernment Initiatives100 per cent Foreign Direct Investment (FDI) is allowed under automatic route in the drugs andpharmaceuticals sector including those involving use of recombinant technology.Also, FDI, up to 100%, is permitted for brownfield investments (i.e. investments in existingcompanies), in the pharmaceuticals sector, under the Government approval route.The Government plans to set up Good Laboratory practices (GLP) Compliant, ChemicalLaboratories, Biological Laboratories and Large Animal Facilities in Public Private PartnershipMode.It also proposes to set up a National Centre for R&D in bulk drugs at National Institute ofPharmaceuticals Education and Research (NIPER), Hyderabad and a National Centre forMedical Devices at NIPER, Ahmedabad.Pharma Export Promotion Council (Pharmexcil)
    • The Department had played a pivotal role in the formation of Pharmexcil consequent to therecommendation from 9th Five YearAnnual Plan Working Group Report on Drugs andPharmaceuticals. In the light of this, the Department constantly interacts with Pharmexcil in theirwork areas. The role of Pharmexcil is for facilitation of exports of Drugs, Pharmaceuticals,Biotechnology products, Herbal medicines and Diagnostics, to name a few.It is authorized toissue Registration-cum-Membership Certificate (RCMC) which is one of the requirements forthe importers and exporters of commodities.In addition to this, Pharmexcil is concerned with giving export thrust to the various productsthrough visits of delegations to various markets abroad, organizing of seminars, workshops andexhibitions.As a major area of work, Pharmexcil also holds Buyers/Sellers meets and compilesdetailed data base on pharma exports and problems in exporting pharma group products ofPharmaceuticals.Key Strengths of Pharma Sector Low cost of innovation/Manufacturing/Capex costs/expenditure to run a cGMP compliance facility. Low cost scientific pool on shop floor leading to high quality documentation. Proven track record in design of high tech manufacturing facilities. Excellent regulatory compliance capabilities for operating these assets. Recent success track record in circumventing API/formulation patents. About 95 per cent of the domestic requirement being met through domestic production. India is regarded as a high-quality and skilled producer in the world. It is not only an API and formulation manufacturing base, but also as an emerging hub for: Contract research Bio-technology Clinical trials and Clinical data management. The country has the distinction of providing quality healthcare at affordable prices.Top 20 destinations of Indian Pharma products for the period April-December 2010INDUSTRY & SERVICESGovernment Initiatives100 per cent Foreign Direct Investment (FDI) is allowed under automatic route in the drugs andpharmaceuticals sector including those involving use of recombinant technology.Also, FDI, up to 100%, is permitted for brownfield investments (i.e. investments in existing companies), inthe pharmaceuticals sector, under the Government approval route.The Government plans to set up Good Laboratory practices (GLP) Compliant, Chemical Laboratories,
    • Biological Laboratories and Large Animal Facilities in Public Private Partnership Mode.It also proposes to set up a National Centre for R&D in bulk drugs at National Institute of PharmaceuticalsEducation and Research (NIPER), Hyderabad and a National Centre for Medical Devices at NIPER,Ahmedabad.Pharma Export Promotion Council (Pharmexcil)The Department had played a pivotal role in the formation of Pharmexcil consequent to therecommendation from 9th Five YearAnnual Plan Working Group Report on Drugs and Pharmaceuticals. Inthe light of this, the Department constantly interacts with Pharmexcil in their work areas. The role ofPharmexcil is for facilitation of exports of Drugs, Pharmaceuticals, Biotechnology products, Herbalmedicines and Diagnostics, to name a few.It is authorized to issue Registration-cum-Membership Certificate(RCMC) which is one of the requirements for the importers and exporters of commodities.In addition to this, Pharmexcil is concerned with giving export thrust to the various products through visitsof delegations to various markets abroad, organizing of seminars, workshops and exhibitions.As a majorarea of work, Pharmexcil also holds Buyers/Sellers meets and compiles detailed data base on pharmaexports and problems in exporting pharma group products of Pharmaceuticals.Key Strengths of Pharma Sector Low cost of innovation/Manufacturing/Capex costs/expenditure to run a cGMP compliance facility. Low cost scientific pool on shop floor leading to high quality documentation. Proven track record in design of high tech manufacturing facilities. Excellent regulatory compliance capabilities for operating these assets. Recent success track record in circumventing API/formulation patents. About 95 per cent of the domestic requirement being met through domestic production. India is regarded as a high-quality and skilled producer in the world. It is not only an API and formulation manufacturing base, but also as an emerging hub for: Contract research Bio-technology Clinical trials and Clinical data management. The country has the distinction of providing quality healthcare at affordable prices.Top 20 destinations of Indian Pharma products for the period April-December 2010 S. No. Importing country Amount (US$ million) 1 USA 1791.0 2 UK 263.9 3 Germany 243.6 4 South Africa 226.8
    • 5 Russia 221.4 6 Brazil 165.0 7 Nigeria 154.1 8 Kenya 137.3 9 Netherlands 131.7 10 Turkey 119.0 11 Canada 108.0 12 Viet Nam 102.8 13 China 100.4 14 Ghana 99.6 15 France 98.0 16 Israel 97.0 17 Spain 94.5 18 Sri Lanka 92.4 19 Italy 91.2 20 Ukraine 90.5Source: Directorate General of Commercial Intelligence and Statistics (DGCIS) KolkataResearch and DevelopmentIn no other Industry segment innovative R&D is as critical as in Pharma industry. Here, the New DrugDiscovery Research (NDDR) has to keep pace with the emerging pattern of diseases as well as responses inmanaging existing diseases where target organisms are becoming resistant to existing drugs. The NDDR isalso an expensive activity. It is encouraging to observe that at least 10 Indian companies are into new drugdiscovery in the areas of infections, metabolic disorders like diabetes, inflammation, respiratory, obesity &cancer. Most of these companies have increased their R&D spending to over 5 per cent of their respectivesales turnovers. There is notable success from some Indian companies in out licensing new molecules in theasthma and diabetes segments to foreign companies. Introduction of Product Patent for Pharmaceuticals isan important feature for Indian Pharma R&D scenario. This has boosted the confidence of MNC Pharmacompanies in India where a number of western Pharma companies have already R&D collaborations withIndian Pharma companies in the field of NDDR. Some Indian companies have also got US-FDA approvalsfor their new molecules as Innovative New Drugs (lND).Western Pharma companies have recognized the attractiveness of India as a R&D outsourcing destinationdue to low cost scientific manpower, excellent infrastructure, top quality with capability to conduct modernresearch under GLP, GCP guidelines. Many of them have set up independent R&D centres in India.Clinical Trials to establish safety and efficacy of drugs constitute nearly 70 per cent of R&D costs.
    • Considering the low cost of Research and Development in India, several MNC Pharma companies as wellas global Clinical Research Organizations are increasingly making India a clinical research hub. Inconclusion new drug discovery in India has made a promising start wherein at least five to six potentialcandidates in the areas of Malaria, Obesity, Cancer, Diabetes and Infections are likely to reach Phase IIclinical trials.Contract ManufacturingMany global pharmaceutical majors are looking to outsource manufacturing from Indian companies, whichenjoy much lower costs (both capital and recurring) than their western counterparts. Many Indiancompanies have made their plants cGMP compliant and India is also having the largest number of USFDA-approved plants outside USA.Indian companies are proving to be better at developing Active Pharmaceutical Ingredients (APIs) than theircompetitors from target markets and that too with non-infringing processes. Indian drugs are either enteringin to strategic alliances with large generic companies in the world of off-patent molecules or entering in tocontract manufacturing agreements with innovator companies for supplying complex under-patentmolecules.Some of the companies like Dishman Pharma, Divis Labs and Matrix Labs have been undertaking contractjobs for MNCs in the US and Europe. Even Shasun Chemicals, Strides Arcolabs, Jubilant Organosys,Orchid Pharmaceuticals and many other large Indian companies started undertaking contract manufacturingof APIs as part of their additional revenue stream. Top MNCs like Pfizer, Merck, GSK, Sanofi Aventis,Novartis, Teva etc. are largely depending on Indian companies for many of their APIs and intermediates.INDUSTRY & SERVICESInternational Co-operation/Export PromotionAn important focus area for the department of Pharmaceuticals is promotion of Indian pharmaexports. The Department participated in the following International Cooperation events during2010-11:- Participation in the 7th India-US High Technology Cooperation Group Meeting held in Washington,in March 2010. Participation in the AdvaMed MedTech Conference held in October 2010 in Washington DC and participation as Co-Chair in the US-India High Technology Cooperation Group, Biotechnology and Life Sciences Working Group Meeting held in October 2010 in Washington DC. Organization of India Pharma Summit 2010 which was held in Mumbai on 30 November 2010.The Department of Pharmaceuticals also provided financial assistance for the following
    • activities/events for promotion and development of the Pharma sector: Organization of a meeting in Mumbai for facilitating Pharma Small Scale Industries (SSI) units in Maharashtra to avail Credit Linked Capital Subsidy Scheme (CLCSS) for Schedule �M compliance. Organization of a meeting at Hyderabad for facilitating Pharma SSI units in Andhra Pradesh to avail CLCSS for Schedule M compliance. Organization of National Convention on Bio-Pharma. Study on Pharma Industry by Institute of Economic Growth. Pre-feasibility study on development of a Greenfield Project for Medical Devices Cluster in Gujarat and a Brownfield Project for Bulk Drugs cluster in Andhra Pradesh. Financial Assistance to Federation of Indian Chambers of Commerce and Industry (FICCI) for Lay-out and designing of Information Brochure to be sent to Indian High Commissions for promoting Pharma Brand India .Major Pharmaceutical Public Sector Undertakings Indian Drugs & Pharmaceuticals Limited (IDPL) Hindustan Antibiotics Limited (HAL) Bengal Chemicals & Pharmaceuticals Limited (BCPL) Rajasthan Drugs and Pharmaceuticals Ltd. (RDPL) Karnataka Antibiotics & Pharmaceuticals Ltd. (KAPL)Major Pharmaceuticals Industries in India Aurobindo Pharma Ltd Aventis Pharma Ltd Cadila Pharmaceuticals Ltd Cipla Ltd Dabur Pharma Ltd Deys Medical Stores Mfg. Ltd Dr. Reddys Laboratories Ltd Elder Pharmaceuticals Ltd Glenmark Pharmaceuticals Ltd Glaxo SmithKline Pharmaceuticals Ltd Lupin Ltd Merck Ltd, India Piramal Health Care Novartis India Pfizer Ltd
    • Ranbaxy Laboratories Ltd Wockhardt Limited Wyeth Laboratories LtdPolicy FrameworkNational Pharmaceuticals Policy, 2006 (.pdf)Useful Web linksDepartment of Pharmaceuticals: http://pharmaceuticals.gov.in/