Healthcare industry in the United States and around the world is rapidly changing, leading to many describing the healthcare environment as dynamic, complex, and highly uncertain. The manner in which the health care environment is perceived and characterized is important for several reasons.
The American Association of Physicians of Indian Origin (AAPI), continuing with the past traditions on the successful experiences has stated that AAPI supports the FDA Commissioner Scott Gottlieb’s Initiatives as pronounced in his statement on February 22nd, urging globally uniform standards utilized for quality control monitoring, including for overseas generic drug manufacturers.
“Advances in technology and material science are enabling new opportunities to transform health and mobility through innovations in medical products. The FDA is committed to adopting pathways that allow patients efficient access to these safe and effective products,” Dr. Gottlieb said.
The Indian pharma companies have established their strong presence in the global pharma landscape that was dominated by the multinational pharma companies predominantly based out of Europe and USA.
According to Dr. Suresh Reddy, President of AAPI, “With the changing trends and statistics in healthcare, both in India and US, we are refocusing our mission and vision, AAPI would like to make a positive meaningful impact on the healthcare delivery system both in the US and in India.”
“AAPI thus supports large research-based Indian companies that manufacture generic drugs and applauds their major role in providing medications at more affordable cost to patients globally, including in the United States,” said Dr. Ravi Jahagirdar, Past President of AAPI. The national and international presence and impact of the Indian Pharmaceutical industry with its progressive vision has included its role in cost containment resulting in affordability, involvement in biosimilars, specialty drugs and gene therapy, which is an ambitious plan to expand the impact of Indian pharmaceutical companies across the globe, while seeking to make quality medicine affordable and available to billions of people all over the world.
Indian Pharmaceutical companies and their subsidiaries have established strong presence in US during the past few years with higher ANDA approvals. The loss of patent exclusivity and cost cutting measures adopted by several nations pushed the demand for generic segment. Indian pharma companies enhanced their investments in research and development (R&D) and successfully received higher approvals from US FDA during last decade. Out of total 5,350 ANDA approvals between 2009 to 2018, Indian companies have secured 34.4% of these approvals and received total 1,842 ANDA final approvals. Further, out of total 1,310 tentative approvals, Indian companies grab 500 tentative approvals from US FDA which worked out to over 38.2%.
India is home to the second highest number of US FDA approved facilities. The Pharma industry in India has posted a robust, double-digit growth over the last few years. The industry was worth USD 36.7 billion in 2017 and is projected to grow to USD 55 billion by 2020. India is now among the top five pharmaceutical emerging markets of the world.