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Regulatory Changes: Overcoming Hurdles

Regulatory Changes: Overcoming Hurdles

The pharmaceutical industry is World’s recession proof industry that is growing rapidly every day and this growth is bringing about tremendous change in regulatory plot. The regulatory system makes efforts to ensure a quality supply of effective and tested drugs to the public at an affordable price. According to market research survey done by Indian Brand Equity Foundation (IBEF), Indian Pharmaceutical Industry accounts for 2.4% of globally in terms of value and 10% in terms of volume. Out of total generic exports, we account for 20%.  Pharmaceutical products of USD 16.89 billion were exported which is expected to reach to USD 40 billion by 2020. Compound annual growth rate of industry for 2015-2020 is 12.89. Foreign direct investment policies (FDI) are being promoted by National Government currently. Indian Pharma sector ranked 5th in terms of attracting FDI. Considering advantages of Indian market, ex. Cost efficiency, more than 250+ US FDA approved plants, trained workforce, diversified portfolio, and governmental support; Indian pharma market is still growing and is at top of most other industrial sectors.  However, regulatory changes are the most important hurdles that are affecting this industry.

Indian regulators are changing and making themselves market ready so as to conquer the world market

Amrit Karmarkar & Aditya Chachad

As pharmaceutical industry is world’s largely controlled industry, regulations are part and parcel of its working. In line with global authorities, Indian regulators are also changing and making themselves market ready so as to conquer world market.  Considering this fact, present review has been designed to give overview of regulations and regulatory changes and how they have impact on industry.

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Original Article Published in Ingredients South Asia, 16-30 April, 2017  (Vol. 10, Issue 14) Page: 57-60

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