Hyderabad: Pharmaceuticals Export Promotion Council of India (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has made unsubstantiated, unqualified and unsolicited comments about select Indian pharmaceutical companies based on out-of-date allegations from more than a decade ago.
The inferences in the book, which was published on May 14, 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, told Telangana Today, “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.
He added, “The Indian pharma industry accounts for 10 per cent of global pharma production in terms of volume, 3 per cent in terms of value. About 55 per cent of the country’s exports are to highly regulated markets. The US is the largest exporting partner of India. In US, generic drugs account for 90 per cent of retail prescriptions. And 40 per cent of generics marketed in US are from India. India accounts for about 37 per cent of Drug Master Files filed with the US.”
There is a substantial increase in share of the US FDA abbreviated new drug application (ANDA) approvals for Indian companies from 26 per cent in 2011 to 38 per cent in 2018. India has the highest number of US FDA approved sites outside USA (over 17 per cent of US FDA approved sites).
Indian pharmaceuticals industry contributed an estimated saving of over $80 billion in 2017 by supplying generic medicines to the US. 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 per cent were classified as OAI (Official Action lndicated). The percentage has come down significantly from 15 per cent (OAI) in 2017. There is a consistent growth in exports to the US from $4.3 billion in 2014-15 to $5.8 billion in 2018-19.
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.”
Positive past testimonies
Udaya Bhaskar added, “As a testimony to the Indian life sciences industry’s excellence in manufacturing high-quality generics, we draw inspiration from the recent statements made by US FDA former commissioner Scott Gottlieb and director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, on the FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad.”
Moreover, 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 using testing standards set by the United States Pharmacopeia (USP) or submitted in marketing applications.
Janet Woodcock, director, Center for Drug Evaluation and Research (CDER), US FDA recently stated, “Safety, efficacy, and quality remain top priorities as we continue our work to expand access to cost-saving generic drugs for the American public.”