India: The right opportunity for your medical device or IVD?

India is one of the larger medical device markets in Asia, and growing at an impressive rate. Increased health awareness, a growing middle class and government health initiatives mean the market is expected to grow about 15% per year for the next several years.

Let me start by saying that if you are planning to enter the Indian market simply because it has 1.3 billion people, manage your expectations and do your homework first. Quantity does not equal opportunity. India healthcare spending is growing quickly but from a very low base. The country only spends $61 per person on healthcare compared to $367/person in China which has roughly the same size population. (The US spends an absurd $9,146/person on healthcare, and Germany spends $5,006/person) 

A brief overview of India:

  • Population is over 1.29 billion, including a growing middle class with access to high quality health care
  • 676 Districts and 638,000 small villages well connected by road/air/major ports to accommodate population
  • Distribution can be complex with 7 union territories and 29 states, all with different local languages and cultures
  • The most widely spoken language is Hindi, but English is the business language
  • Hindi is not spoken in the South; South Indian states have their own regional languages
  • 15 official languages and many more unofficial languages
  • India relies on imports for medical devices (~75% of medical devices in India are imported)
  • 60%-70% of the government tender market is in Delhi
  • 4 important economic regions: North (Delhi), South (Bangalore, Hyderabad and Chennai), West (Mumbai ), East (Kolkata ):
  • Distribution support is conducted per region: North, South, East and West
  • Each region is subdivided into tiered cities depending on size (Tiers 1 - 3)
  • Tier 1 are the largest cities in India (~40) and 75 % - 80% of high end devices are used in these cities by government and privately - owned hospitals
  • People in smaller Tier 2 and 3 cities will travel to the hospitals in Tier 1 cities.

India Medical Device Registration and Approval

Before manufacturers can legally sell medical devices within India, they must be in compliance with India medical device regulations. Prior to 2005, no regulations whatsoever existed for medical devices in India. Today there are registration procedures for certain types of medical devices regulated under the provisions of the Drugs and Cosmetics Rules. Comprehensive legislation governing medical devices is pending. You can download our chart showing the Indian device and IVD regulatory process here

Manufacturers interested in registering their medical devices in India  must supply evidence of prior regulatory authorization in the US, Canada, Europe, Australia or Japan, as well as proof of approval in their home market. Full technical documentation must be submitted for review by the Central Drugs Standard Control Organization (CDSCO). Additionally, each manufacturing facility must be registered.

Keys to success in India

The opportunities in India are overwhelming, but what is the best way to take advantage of them? Here are a few recommendations based on the experience of Emergo local distribution consultant Mr. Raman Rao.  “Think Global, Act Local", products are welcome as "imported", but not with your home country pricing and service requirements. The Indian population has certainly changed the way they think in terms of quality of service or products. They do want the best, but not at the highest price, they will pay for quality but not at the prices found in the West. It’s better to sell at a bit lower price than in western countries in order to sell more.

Do your homework well through local resources. Market research companies sometimes provide inflated numbers on the Indian market. Do not get carried by a report only by the reputation or experience of the research organization. Get your insights through opinion leaders in your specific domain. Such experts will not only be more reasonably priced to conduct a ‘real' market research than some of the well-reputed market research firms. They also stand a better chance providing you with the numbers closer to reality!

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