Presentation on theme: "PHARMA INDUSTRY – EMERGING CHALLENGES AND OPPORTUNITIES"— Presentation transcript:
1 PHARMA INDUSTRY – EMERGING CHALLENGES AND OPPORTUNITIES Jawaharlal Nehru Pharma City(Developed by Ramky Group and APIIC)Parawada, Vishakhapatnam DistrictA Sector Specific Industrial Park for Bulk Drug, Pharmaceuticals & Fine Chemicals.Government of AP initiative under Public Private Partnershipon Build Own Operate (BOO) basisDr P.P. Lal KrishnaChief Executive OfficerRamky Pharma City (India) Ltd
2 Agenda Pharma industry overview Opportunities for Indian pharma Regulatory ApprovalsJawaharlal Nehru Pharma-city – An overviewNeed for IncubatorsCluster Development ApproachRole of Cost Accountants in Pharma IndustryConclusion
3 History of Pharma sector in India:- Started its journey in 1903 when professor D.C Roy forward Bengal chemical and pharma clinical works in Kolkata.During half of the 20th century, Indian government largely dependent on the UK, France and Germany for medicine.The new and independent government in 1947 Emphasized on Industrialization to achieve self reliance and therefore invested heavily in pharmaceuticals among other industries and reduced import of medicinesThe government takes its first concrete steps towards self reliance in pharmaceutical sector in 1954 with the establishment of Hindustan antibiotics ltd (HAL) and in 1961 establishing Indian Drug and Pharmaceutical Limited
4 Indian Pharma TodayIt’s a $ 20 bn industry divided almost equally between domestic and exportsGrowing at a healthy 2 digit ratePoised to touch $ 40 bn by 2015Already emerged as a “preferred” sourcing hub for the global fraternityOne of the mature marketsAlmost 98% drugs are made locally
5 Indian Pharma Today Good balance between MNCs and Indian companies Becoming leader in Generic formulationsReasonably strong in APIs tooA truly global presence
6 Opportunities for Indian Pharma Generic Opportunity: 450 molecules worth USD350bn are going off- patent in the coming years (Source: McKinsey)The contract manufacturing opportunity of prescription drugs is estimated to increase from a value of USD26.2 billion to USD43.9 bn. in the next 5 years.There are many important categories such as monoclonal antibodies, peptides, biotech, etc., which are not filed by India forgoing a global opportunity of appx.USD90bn.Several technologies such as sustained release/controlled/modified release Lyophilized Pharmaceuticals, bio-pharmaceuticals, Specialty generics, Drug Intermediates, NIP based APIs/Formulations, regulatory compliant infrastructure are not attempted in India. There are more than drugs in this category with an opportunity of USD50bn.
7 Opportunities for Indian Pharma In the drug research value chain, there are certain key strengths such as:Significant valid population to participate in clinical trialsSignificant capabilities in medical skills, hospital beds and IT.There exists an opportunity to capture the market share in global clinical R&D market such as clinical trials, data management, testing etc.By 2012, nearly half of all newly approved prescription drug products will be biologics.
9 Name of Regulatory Agency Regulatory ApprovalsAuthorityName of Regulatory AgencyNos.USADMFs filed with U.S. FDA (companies) (As on Sept 2012)225No: of Sites(Bulk drugs + Formulations) Approved by US FDA (as on 30th Sept 2013)390Total No Of DMF’s (Type II Active) Filed from India (as on 30th Dec 2013)3411ANDAs(As on 31st Dec 2013)2661Formulation companies with USFDA approvals.32EUROPENumber of CEPs received (as of 31stJan 2014)1105Number of companies with CEPs155Number of Molecules for which CEPs have been filed with EDQM344No of Sites approved by EDQM In India(As on 30th April 2013)353UK MHRA (Medicines Healthcare Regulatory Agency), Market authorizations as March 20131110Number of CEPs with Irish Medicines Board300Number of companies registered in Irish Medicines Board19number of Authorisations with Sweden MPA (Läkemedelsverket)209Number of companies having MA`s with Sweden MPA (Läkemedelsverket)14WHO GMPWHO GMP Certified Plants (as per Drug Controller General of India)1270 (approx.)EthiopiaDACA (Drug Administration and Control Authority), Ethiopia (companies)50Tanzania(TFDA) Tanzania Food and Drugs Authority (companies)1373
10 Need of the hourPharma infrastructure which allows the manufacturers to focus only on producing and marketing the products in a seamless way without having to worry about many corollary issues like pollution, effluents, testing labs, BioE labs , logistics etc.
11 Jawaharlal Nehru Pharma City Bridging the GapJawaharlal Nehru Pharma City - Sector Specific Industrial Park for Pharma companies Developed by Ramky Group & APIIC has been promoted in order to bridge this gap.Offering a world-class facilities, in a convenient city with all essential services for the pharmaceutical companies which will help them save on investments alsoJawaharlal Nehru Pharma CityWorld Class FacilityFiscal Benefits of locating in an SEZ
12 JNPC- excellent pedigree JNPC is the brainchild of Ramky group- a leading name in Infrastructure spaceRamky is a 17 yr old, $ 2 bn, employee group today with Presence in India, UAE, Africa and SingaporeWith presence in infrastructure, Environmental engineering, Real estate, other allied industries
14 Salient Features of JN Pharma City JNPC offers world-class common infrastructure, common utilities & basic amenities.Power with dedicated sub-station – 132/33/11 KV with backup feederDedicated Water supply scheme of 20MLD and summer storage tank in an extent of 250 AcresTwo Lane well paved Road network of 32 KmStreet lighting with underground cablingCommon Effluent Treatment Plant of 12 MLD CapacityHazardous Waste Management Facility-6 Lakh Ton CapacityMarine Outfall Pipeline for disposal of treated effluents of length 16 Km onshore & 1.8 Km off shore with a diffuser depth of 18mPlanning for Exclusive Township close to JN Pharma City
15 Plug-n-Play Facility Effluent & Storm water Conveyance A dedicated 1000 Line telephone exchange with Broadband internet connectivityCentral Fire Protection servicesCommon security & surveillancePlanning for Logistics hub, Chemical Feedstock, Container terminals & Common Warehouse facilityAmenities include Banks, ATM’s, Primary health centre, food courts & Club house etc…Exclusive pharma R&D center
17 Common Effluent Treatment Plant at JNPC Salient Features:Capacity : 12 MLDSeparate Low TDS & High TDS effluent conveyance Pipe Line Network.Air Strippers for removal of Volatile Organic CompoundsIncinerator / regenerative thermal Oxidiser for destruction of Volatile Organic CompoundsFully automated Cyclic Biological Activated Sludge Treatment PlantSeparate Treatment for Cyanides, Heavy Metals & other wastes.Multiple Effect Evaporators for High TDS effluent treatmentPowdered activated carbon treatmentGuard ponds for toxicity checkMarine Outfall Pipelines - disposal of treated effluents
18 Project Background Effluent Collection Incinerator Marine Out fall Off shorePharma UnitsEffluent CollectionCETP (12 MLD)Diffuser- 15 Mt.Marine Out fallIncinerator
20 Support Infrastructure Central Instrumentation centerWet laboratoriesCentral fire protection servicesEmergency medical centerLogistics hub & truck terminalsParking BayCentral warehousesCustoms bonded warehouses & ICDBulk solvents storageCentral workshopsPetrol & diesel outlets
21 Land Sales Details No. of Units Total Area Allotted in acres Non-SEZ Area & SEZ areaDetailsNo. of UnitsTotal AreaAllotted in acresLand allotted as on date1041189Land allotted in percentage 86
22 Success Story of JNPC Concession Agreement made during the year 2004 Operations started during the yearAs on today land allotted to about 86% of the park capacityEmployment provided to the tune of people and indirect employment is several timesInvestment brought to pharmacity is about Rs 7000 CrOccupants are from Innovators, Generic companies, Indian giants, multinational companies & first generation entrepreneursContinual improvement in upgrading technologies and facilities to meet the customer requirementsThis project is undertaken under PPP model with private participation and this is one of the successful pharma park in India
24 ROLE OF Cost Accountant in Pharma Industry Pharma Industry is competing with China and other developing /developed nationsIn fact 60% of Raw Materials are imported from China, even the technologically India is superiorCosting of the Process and Product will play a major role in competing with China and other countriesThe Critical Parameters for Cost Accountants in Pharma industry is distribution of Utility Cost for the product and man power allocation costCost Accountant plays a crucial role in marketing the product
25 ROLE OF COST AND MANAGEMENT ACCOUNTANT IN THE GROUWTH OF PHARMA SECTOR There are numerous factors responsible for its growth like R&D, Govt; policy, patent act etc; besides these factors there is one important input which enables Indian pharma sector to compete with other players. i.e cost effectiveness.CMA works hard in supplying the required cost date for enabling the decision makers in taking strategic decisions like launching of new generic drugs, making alliances with other firms, capital investment in technology, infrastructure building
26 ConclusionResidual Andhra Pradesh will attract more investment because of business opportunities and availability of technical manpower in this reasonsIf MAT & DDT is removed more MNCs will invest in our Region in SEZMore investments are possible after the tax benefits to Residual Andhra PradeshPolitical Support and support by bureaucrats will boost the investment in this region