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PHARMACEUTICALS

FDI in Pharmaceuticals in India

India enjoys an important position in the global pharmaceuticals sector with a 20% share of generic medicines in supplies by volume. Indian pharmaceutical sector industry supplies over 50 per cent of global demand for various vaccines, 40% of generic demand in the US and 25% of all medicine in UK.

India is the source of 60,000 generic brands across 60 therapeutic categories and manufactures more than 500 different Active Pharmaceutical Ingredients (APIs). The export of generic drugs is one of India's core strengths. The country’s pharmaceutical exports stood at US$ 17.27 billion in FY18 and have reached US$ 19.14 billion in FY19. Presently over 80% of the antiretroviral drugs used globally to combat AIDS are supplied by Indian pharmaceutical firms.

100% Foreign Direct Investment (FDI) in pharmaceuticals in India is allowed under the automatic route for green-field pharma.

100% Fdi In Drugs And Pharmaceuticals In India is allowed in brownfield pharma; wherein 74% FDI in the Pharmaceuticals Sector is allowed under the automatic route and thereafter through government approval route.

20 %

Generics medicines exports share(global)
11.9 %

Contribution in overall exports
70 %

Generic drugs revenue share
21 %

Patented drugs revenue share

1

Largest vaccine producer in the world
2

Bio-Pharma is the largest sector contributing to 62% of the total revenue
3

4th largest medical device market in Asia

The pharmaceutical industry was valued at $ 36.7 bn in 2018. The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4% over 2015–20 to reach USD $55 bn
India’s pharmaceutical exports stood at USD $17.27 bn in FY18 and have reached USD $15.52 bn in FY19 (up to January 2019)
The Pharmaceutical industry in India accounts for about 2.4% of the global Pharmaceutical industry in value terms
Indian companies received 304 Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration (USFDA) in 2017. The country accounts for around 30% (by volume) and about 10% (value) in the USD $70-80 bn US generics market
Generic drugs with 70% market share form the largest segment of the Pharmaceutical industry in India. Over-the-counter (OTC) medicines constitute around 21% of the market while patented drugs have a 9% share
India is currently among the top 20 global Medical device markets and the 4^th largest medical device market in Asia

Innovation and R&D
To develop new complex generic drugs
Medical tourism
Quality services at marginal costs compared to US, Europe, and South Asia
Infrastructure development
6 pharma and 2 medical devices parks in the pipeline
New IPR policy
Increased control over patent infringement
Strong drug manufacturing
Expertise in low cost generic patented drugs

May 2019: Online pharmacy Medlife has acquired Bengaluru based medicine delivery start up Myra. Medlife will use the delivery segment to expand its services to 22 cities.
Feb 2019: Indian pharmaceutical market grew by 10% year-on-year.
Oct 2018: Active pharmaceutical ingredients (APIs) and drug intermediates maker Divis Laboratories Limited is creating additional capacities by spending as much as Rs.15000 crores at its existing facilities in the next 15 months
Sep 2018: Indian pharma sector witnessed 39 PE investment deals worth USD $217 mn.
Jul 2018: Swiss pharma giant Ferring Pharmaceuticals will be investing $250 mn in setting up a manufacturing facility and R&D centre in the city’s life sciences hub of Genome Valley.
Jun 2018: Tyumen has joined a growing list of Russian regions keen on playing host to pharmaceutical ventures of Indian firms, a move that comes in the backdrop of Russia’s emphasis on building self-reliance in drug production.

$16.2 bn FDI in pharmaceuticals in drugs & pharmaceuticals during April 2000 – June 2019
100 per cent FDI in pharma sector allowed in green-field pharma
74% FDI in the pharmaceuticals sector is allowed for brownfield pharmaceuticals projects