June 2014

India: Market Access Tracker


Last Updated 4 June 2014
Multinationals looking to build a flourishing business in India are facing strong pushback from government activities to curb prices, a proactive judiciary that is reigning in the breadth of patents, and regulatory agencies that are strengthening clinical regulations and oversight. MNC strategies that worked in the near past will no longer be appropriate for the rapidly-evolving commercial environment in India and must be replaced with new operating models for this very important emerging market.


Market profile: Market access drivers; key opportunities and challenges; analysis of more than 40 market parameters.

Economic outlook: Global, regional, and country growth rates, 2011-2014.

Socioeconomic trends of 11 Asia Pacific countries: Gross domestic product (GDP), nominal per capita gross national income (GNI).

Demographics of 11 Asia Pacific countries projected to 2030: Population size; population growth rate; life expectancy at birth; median age; percentage of population aged 65 or more; percentage of population that is urban; tier I and tier II markets based on population; morbidity and mortality.

Healthcare investments of 11 Asia Pacific countries: Healthcare spending as percentage of GDP (2000-2010), healthcare spending by government and private entities (2010); healthcare spending per capita (2000-2010).

Pharmaceutical markets (3 regions and 15 countries): Ranking by size; market sizes; market growth.

Healthcare system: Healthcare spending; organization; public system; health insurance; out-of-pocket payments; lists of essential medicines.

Intellectual property: Patent acts, reverse engineering; TRIPS, vagaries of system for multinational companies; product patent status; TRIPS-plus status; India-EU free trade agreement; novelty requirements for compounds of different forms; drug patent actions; compulsory licenses; differential pricing.

Pharmaceutical regulation: Key decision makers; laws and rules; clinical trial regulations; counterfeit and substandard drugs; biosimilars; biologics; parliamentary report on CDSCO.

Pharmaceutical pricing and admission to reimbursement: National List of Essential Medicines; key decision makers; price controls; maximum allowable post-manufacturing expenses; scheduled medicines; price calculation formulas; allowed minimum markups for medicines; maximum retail prices; nonscheduled medicines; price adjustments; draft National Pharmaceutical Pricing Policy; proposed price control of patented drugs; penalties for overcharging; pricing strategies of five multinational companies; distribution challenges.

Pharmaceutical market: Promoting generics; purchasing preference policy; Jan Aushadhi initiative; public educational programs; Common List of unbranded generics.

Outlook and implications for the pharmaceutical industry: 13 key factors to appreciate when doing business in India.

Exhibits: 22 data-rich tables and figures.

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Mentioned in this report:

  • Organizations:
  • - Association of Biotechnology Led Enterprises (ABLE)
  • - Biotechnology Industry Research Assistance Council (BIRAC)
  • - Bureau of Pharma Public Sector Undertakings of India (BPPI)
  • - Biotechnology Regulatory Authority of India (BRAI)
  • - Center for Traditional Medicines and Research (CTMR)
  • - Central Drug Authority (CDA)
  • - Central Drug Standard Control Organization (CDSCO)
  • - Central Government Research Institute
  • - Committee on Price Negotiations for Patented Drugs
  • - Confederation of Indian Pharmaceutical Industry (CIPI)
  • - Office of the Controller General of Patents, Designs, and Trademarks (CGPDTM)
  • - Department of Biotechnology (DBT)
  • - Department of Industrial Promotion and Policy (DIPP)
  • - Directorate General of Health Services (DGHS)
  • - Department of Pharmaceuticals (DOP)
  • - State Food and Drug Administration (FDA)
  • - Federation of Indian Chamber of Commerce and Industry (FICCI)
  • - Federation of Pharma Entrepreneurs (FOPE)
  • - Food Safety and Standards Authority of India (FSSAI)
  • - Genetic Engineering Appraisal Committee (GEAC)
  • - Indian Drug Manufacturers’ Association (IDMA)
  • - Indian Drugs and Pharmaceuticals (IDPL)
  • - International Institute for Population Sciences (IIPS)
  • - International Monetary Fund (IMF)
  • - Indian Pharmaceutical Alliance (IPA)
  • - Intellectual Property Appellate Board (IPAB)
  • - Ministry of Commerce and Industry
  • - Ministry of Environment and Forests (MoEF)
  • - Ministry of Health and Family Welfare (MoHFW)
  • - Ministry of Science and Technology
  • - Medical Product Counterfeiting and Pharmaceutical Crime (MPCPC)
  • - National AIDS Control Organization (NACO)
  • - National Council of Applied Economic Research (NCAER)
  • - New Drug Advisory Committee (NDAC)
  • - National Institute of Intellectual Property Management
  • - National Pharmaceutical Pricing Authority (NPPA)
  • - Organization for Economic Cooperation and Development (OECD)
  • - Organization of Pharmaceutical Producers of India (OPPI)
  • - Pricing Committee for Patented Drugs
  • - Review Committee on Genetic Manipulation (RCGM)
  • - Standing Committee on Health and Family Welfare (SCHFW)
  • - State Drug Standard Control Organization (SDSCO)
  • - United Nations International Children’s Emergency Fund (now known as the United Nations Children’s Fund) (UNICEF)
  • - United Nations Population Division (UNPD)
  • - World Health Organization (WHO)
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