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Wednesday, August 27, 2025
TopicFDA

Topic: FDA

Swarms of bugs, missing data plague firms now making heart drug in India

Inspection reports by US federal agency FDA stated that workers destroyed records indicating that drugs were failing key quality measures.

New book warns Americans against ‘flea-market quality’ Indian generic drugs

Bottle of Lies by journalist Katherine Eban accuses Indian pharma firms of fudging data on quality control and toxic impurities, among other major lapses.

US drug authority says some sleeping pills have serious side-effects, need warning on label

The drugs — eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, and Zolpimist) — are commonly prescribed in India too.

Modi govt writes to J&J for details on surgical pelvic mesh after US ban

Govt has sought details on the number of the pelvic meshes that Johnson & Johnson has imported into India in the last 3 years.

Sales of pelvic surgical mesh for women could be stopped in India after US ban

The US FDA stopped the sale of the surgical mesh, used to treat the abnormal descent of the pelvis in women, due to a rise in adverse complaints.   

US drug authority warns Indian homoeopathy firm after it finds insects & rodents at factory

Noida-based B.Jain Pharmaceuticals exports homoeopathy medicines to several countries, including US. It also sells products in India for treatment of diabetes, liver ailments.

How India’s culture of ‘jugaad’ is challenging the US drug agency

'Jugaad', translated as creative improvisation, is credited with the rise in technology and drug making in India. But it can have a darker connotation -- get it done at all costs.

Pfizer’s Viagra patent set to end in the US, Indian pharma firms sense huge opportunity

Seven get FDA approval to produce the drug, could send prices crashing in the US by nearly 99%.

This is how GM crop Golden Rice could solve Vitamin-A deficiency in Asia

US food and drug regulator approves Golden Rice for consumption; among Asian nation, Philippines and Bangladesh lead in research and testing of GR2E.

On Camera

India will absorb Trump tariff impact due to its Achilles’ heel

Like China, India remains a big domestic market, which will continue to attract investment, but the US tariffs will make India unattractive for future investments.

New insolvency frameworks to shorter timelines, how 2025 amendment bill proposes to transform IBC

New bill aims to fix key issues with IBC 2016, including delays & patchy implementation, and protect creditors, with window for genuine promoters to retain control of their companies.

Op Sindoor lesson: IAF chief bats for joint planning & coordination centre in Delhi, not theaterisation

Contrary to claims regarding implementation of theaterisation, ThePrint first reported on 17 June 2021 that it will be delayed. Now, ACM Singh bats for different structure.

That Oval Office picture for ages deserves closer Indian reading, with a geopolitical lens

Putin sees this as a victory. Europeans have decided to deal with Trump on his terms for the sake of the larger Western alliance. We look at the lessons for us in India.