,
11 tweets,
2 min read
Read on Twitter
Indian pharma industry unfairly targeted in the book “Bottle of Lies” : Pharmexcil telanganatoday.com/?p=271118 via @TelanganaToday
Pharmexcil has raised objections over the book written by a former US FDA auditor Katherine Eban, where the author has made unsubstantiated, unqualified and unsolicited comments about select Indian pharma companies based on out-of-date allegations from more than a decade ago.
The inferences in the book are based on past information of select cases and do not present the current situation. In the book, “Bottle of Lies” written by Katherine Eban, the Indian pharmaceutical industry has been unfairly targeted, observed Pharmexcil.
Udaya Bhaskar, director general, Pharmexcil: “The book solely relies on the experience of an ex-US FDA auditor. It completely fails to capture the humongous and massive successful strides made by the Indian pharmaceutical industry in the past several years.”
India is known as “Pharmacy of the World”, supplying high-quality, affordable, safe and efficacious generic medicines to more than 200 countries. The Indian pharma accounts for 10% of global pharma production in terms of volume, 3% in terms of value.
About 55% of India’s exports are to highly regulated markets. US is the largest exporting partner of India. In US, generic drugs account for 90% of retail prescriptions. And 40% of generics marketed in US are from India.
India accounts for about 37% of Drug Master Files filed with the US. There is a substantial increase in share of AND) approvals for Indian companies from 26% in 2011 to 38% in 2018. India has the highest number of US FDA approved sites outside USA (17% of US FDA approved sites).
There is a significant fall in number of warning letters issued to Indian companies. In 2018, US FDA carried out 174 FDA inspections in India, of which 4% were classified as OAI (Official Action lndicated). The percentage has come down significantly from 15% (OAI) in 2017.
Dinesh Dua, chairman, Pharmexcil, said, “At a time when import alerts have significantly reduced from the US, the contents of the book could impact India’s effort to supply quality and affordable drugs.”
Udaya Bhaskar added, “As a testimony to industry’s excellence in manufacturing high-quality generics, we draw inspiration from statements made by US FDA fmr commissioner Scott Gottlieb and director of FDA’s Center for Drug Evaluation and Research Janet Woodcock..."
When US FDA labs tested 323 products from around the world, including more than 100 from India to determine if foreign manufacturers had a higher incidence of product failure, all 323 samples met US market quality standards set by the United States Pharmacopeia (USP)...
