Non-compliance: Bitter pill of the Indian pharma biz

An article in the leading newspaper highlights the effects of the non-compliance of the Indian pharmaceutical industry and its impact on its business fortunes. 

Well-written by Jyothy Datta, tries to answer "Does quality non-compliance threaten to trip-up the Indian pharmaceutical industry, growing at a steady trot of about 15 per cent in the last few years?"

Import alerts against Indian plants in 2013 accounted for 49 per cent of the total 43 imports alerts issued by the US FDA (Food and Drug Administration) worldwide, records an EY report on data integrity compliance.

And a Deloitte report on compliance management points out: “In the last two years, import ban orders have been issued by the USFDA and Canada’s Health Canada to more than 25 Indian API (active pharmaceutical ingredients) and formulations.” 

For the full article, please visit the following link:

http://www.thehindubusinessline.com/features/pulse/noncompliance-bitter-pill-of-the-indian-pharma-biz/article7310163.ece

Pharma Literati