> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# India Drug Firms, Regulators See Quality Value: Valdez
- URL: https://www.fdaweb.com/india-drug-firms-regulators-see-quality-value-valdez/
- Published: 2017-03-28T12:00:00.000Z
- Updated: 2026-09-14T22:14:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138310

FDA associate commissioner for international programs **Mary Lou Valdez** says that regulators and drug companies in India recognize that a quality culture is imperative if the country is to increase productivity, reduce compliance risk, lessen rework, and minimize supply interruptions that result in lost revenue and increased risks to public health. Following February meetings with regulatory counterparts in India, Valdez writes in an *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2017/03/fda-in-india-championing-a-culture-of-quality/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) that “we see India committing to quality and compliance.”

She says that despite diverse mandates and priorities in the Indian agencies with whom she visited, “a common theme coming out of these meetings was the recognition of the mutual benefits we realize by working together to enhance the effectiveness of our regulatory systems and to advance risk-based and science-based approaches to food and medical product regulation.”

Valdez notes that quality issues are an ongoing challenge for the Indian pharmaceutical industry. Of 42 Warning Letters issued by FDA’s Office of Manufacturing Quality last year, she says, nine went to Indian facilities. “Participants agreed that achieving quality requires regulators and industry alike to champion and advance a quality culture throughout the product life-cycle, by effectively employing the use of data and science and requiring greater transparency,” she says.