FDA increases oversight of drug safety in India

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FDA increases oversight of drug safety in India

Genéricos/General | Posted 21/03/2014 0 Post your comment

The US Food and Drug Administration (FDA) has created an Office of Pharmaceutical Quality in response to quality concerns at home and abroad, particularly surrounding generic medicines from several Indian manufacturing plants [1].

‘Consumers should be confident that the products they are using are safe and high quality and when companies sacrifice quality, putting consumers at risk, they must be held accountable,’ wrote Margaret Hamburg, FDA Commissioner, in a blog post following meetings with executives from pharmaceutical exporting companies in India.

Currently, FDA only collects data on manufacturing plants that are failing to abide by regulations. The aim of this new office is to solve potential concerns before tough penalties are needed.

The Office of Pharmaceutical Quality will create one voice for drug quality at the FDA, says Ms Hamburg, and improve oversight of quality throughout the lifecycle of a pharmaceutical product.

Alongside this, FDA has fulfilled one of its commitments under the Generic Drug User Fee Act (GDUFA), requiring the drug regulator to increase the number of foreign inspections the agency carries out. Pharmaceutical company executives who met Ms Hamburg in India said they were challenged by these heightened inspectional activities. ‘I told them that every company supplying the US market has the responsibility of ensuring that their products are safe, effective and of high quality,’ wrote Commissioner Hamburg.

Although the agreement between FDA and India’s Ministry of Health, signed during FDA Commissioner’s visit, is designed to forge ties between the two countries, not everyone is happy. ‘The FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver,’ the Drug Controller General of India, Dr GN Singh told Reuters.

Reference

1. GaBI Online - Generics and Biosimilars Initiative. FDA issues Ranbaxy with Form 483 for violations at Toansa plant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 21]. Available from: www.gabionline.net/Generics/News/FDA-issues-Ranbaxy-with-Form-483-for-violations-at-Toansa-plant

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Source: Bloomberg, FDA, Reuters