Country Report: India

Standing Out from the Crowd

“Over the past few decades, the Indian pharmaceutical industry has established itself as a global powerhouse for the production of bulk drugs and generics which have gained dominant market shares in the world’s most strategic markets and tremendously bolstered healthcare affordability and accessibility on all continents,” states Suresh Prabhu, India’s Minister of Commerce & Industry and Civil Aviation. “India is undoubtedly a significant player in the global marketplace, representing an important source of FDA-regulated products,” confirms Dr. Letitia Robinson, director of the India Office of the US FDA, which was set up in New Delhi in 2008.

When it comes to fine chemicals and pharmaceuticals, India's growth is impressive: “with 573 approved facilities, India continues to have the highest number of US FDA-registered manufacturing facilities outside the US, while over 800 are UK MHRA approved, and approximately 1,400 manufacturing units are WHO GMP (Good Manufacturing Practices) certified,” highlights Dilip G. Shah, secretary-general of the Indian Pharmaceutical Alliance (IPA).

Thanks to the Indian ecosystem’s remarkable expertise in reverse engineering and its unrivaled capacity to provide health systems around the world with large volumes of affordable generic drugs, Indian pharmaceutical exports have skyrocketed from USD 3.9 billion in 2004 to around USD 17 billion today, according to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), while Indian companies make up 25 percent of the US generic market share.

"A question that I have asked myself is where do we go from here?" says Murtaza Khorakiwala, managing director of homegrown entity Wockhardt. "Is it better to be growing by 45-55 percent or be entering other areas as well-such as the development of new molecules, biosimilars, and biotechnology. I believe this is the next wave of the Indian pharma industry.”

To view the full article on India's evolving healthcare and biopharma markets, produced by Focus Reports and featured in Pharm Exec's July 2018 issue, click here. 

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