# 115 - Bottle of Lies, Generic Drugs Quality, Ranbaxy, Audits, and Inspiring Quality Pros with NYT Best-Selling Author, Katherine Eban

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-12-20
- Length: 33m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-20-115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pr
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/115---Bottle-of-Lies--Generic-Drugs-Quality--Ranbaxy--Audits--and-Inspiring-Quality-Pros-with-NYT-Best-Selling-Author--Katherine-Eban-e2d69ec

## Summary

Katherine Eban, author of the New York Times bestseller 'Bottle of Lies', discusses her decade-long investigation into quality failures in the generic drug industry, focusing on the fraudulent practices of Indian manufacturer Ranbaxy. She details how Ranbaxy manipulated and fabricated data to secure regulatory approvals, creating a 'dual-track' system where lower-quality drugs were sent to less regulated markets while better-tested versions went to the US and Europe. Eban highlights the role of whistleblower Dinesh Takur and FDA inspector Peter Baker in uncovering these systemic issues, while also critiquing the FDA's reliance on pre-announced inspections and the ethical culture of pharmaceutical companies.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-20-115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pr#t=0) Introduction and Origin of the Investigation
- [2:12](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-20-115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pr#t=132) The Ranbaxy Fraud and Dual-Track Manufacturing
- [11:13](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-20-115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pr#t=673) FDA Inspection Failures and Data Fabrication
- [18:39](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-20-115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pr#t=1119) Whistleblower Dinesh Takur and Corporate Retaliation
- [27:41](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-20-115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pr#t=1661) Peter Baker and Forensic Auditing
- [30:19](https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-20-115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pr#t=1819) Quality Culture and Consumer Advice

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

large enterprises

## Mentioned

- Bottle of Lies (product)
- Ranbaxy (company)
- FDA (company)
- Pfizer (company)
- Purdue Pharma (company)
- Oxycontin (product)
- People's Pharmacy (company)
- Joe Graden (other)
- Dinesh Takur (other)
- Peter Baker (other)
- WHO (company)
- Self Magazine (company)
- Fortune Magazine (company)
- Lester Crawford (other)
- PDA (company)

## Related episodes from other shows

- [Quality Myths and Lessons Learned](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-19-quality-myths-and-lessons-learned) (Global Medical Device Podcast)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)
- [Fraud in the Healthcare Industry & the Role of Whistleblowers](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-01-12-fraud-in-the-healthcare-industry-the-role-of-whistleblowers) (Global Medical Device Podcast)
- [FDA is Expanding its Case for Quality Program... Should Your Company Participate?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-fda-is-expanding-its-case-for-quality-program-should-your-company-participate) (Global Medical Device Podcast)
- [Meet a Guru: Erica Loring](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-10-28-meet-a-guru-erica-loring) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2023-12-20-115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pr. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.