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,
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
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.
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
Exhibits: 22 data-rich tables and figures.