Video: Every Case Tells a Story| Webinar: ACR/CHEST ILD Guidelines in Practice

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

U.S. & EU Regulators Urge Indian Drug Companies to Step Up Standards

Zeba Siddiqui  |  

“Data integrity really sounds off alarm bells for us … if you see data integrity on the surface, there is likely a lot going on underneath,” Cosgrove said.

The regulators said that it was critical that Indian companies ensure they follow quality standards, especially as they aspire to make original medicines and more complex products, such as biosimilars.

ADVERTISEMENT
SCROLL TO CONTINUE

“Generics is only one part,” said Shanghvi, whose Sun is also the world’s fifth-biggest generic drugs maker. “We need to think about how we can transform into global players.”

Related Articles

    Generic-Drug Price Fixing: Is It Happening?

    It started with an inhaler. Like many of you, I am a rheuma­tologist. And like you, I see some patients more often their own primary care provider. This is so often the case that I have gradually devolved into their backup, all-purpose doctor. I am the doc they notify when they get hospitalized for pneumonia…

    Rheumatologist Fellow Works in India Via ACR Exchange Program

    In November 2017, I went to Lucknow, India, where I would spend my time as an exchange fellow at the Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPIMS) as part of the ACR International Visiting Fellows Exchange Program. Where I Come From I completed my medical degree at Mahatma Gandhi Missions Medical College, Navi Mumbai…

    On the Road in Rajasthan: Vehicular-Caused Bone, Joint Damage in India

    In the good old days, physicians routinely made house calls. The decision to visit the literal bedside of a patient was practical: hospital services were primitive and often offered too little benefit to justify an emergency journey by the patient. These physicians carried leather bags, sometimes called Gladstones, that were filled with instruments for eventualities…

    U.S. Bans Another Indian Drug Plant over Production Quality

    MUMBAI (Reuters)—The U.S. Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action. The FDA’s import alert on Mumbai-based Polydrug Laboratories Pvt Ltd’s Ambernath manufacturing plant comes two months after Canada banned the…