FDA Takes Steps to Strengthen its Relationship with India

March 2, 2016

A large amount of the pharmaceutical products that are imported into the United States are manufactured in India. Accordingly, FDA’s presence in the country has steadily increased over the past several years. Lately, the number of FDA warnings being issued to Indian companies has grown significantly, resulting in an increase in the collaboration between Indian and U.S. regulators.

For the past few months, individuals from FDA’s India office have been partnering with the Indian government’s Central Drug Standards Control Organization (CDSCO), “to share inspectional techniques and guidance for conducting current good manufacturing practices of pharmaceutical facilities.” As part of this partnership, there have been training sessions held in Ahmedabad and Bengaluru, India for about 200 CDSCO regulators and some of the State drug control agencies. In a recent blog post on the topic, the FDA stated that “the training was an example of the cooperation by both agencies to increase knowledge and skills, thereby contributing to the health and welfare of citizens in both countries.”

So far, the partnership has afforded representatives from both agencies the opportunity to learn more about each other first hand. FDA stated that “it was clear from the interactions that the Indian inspectors had extensive knowledge of FDA and of the international techniques for conducting inspections.” In addition, U.S. representatives expanded their knowledge on the differences between FDA and Indian legislation and regulations.

Furthermore, the Agency has declared that individuals from the FDA and the Government of India will continue to work together, leveraging each others knowledge and strengths to ensure patient safety in India and product quality of FDA-regulated pharmaceuticals. It will certainly be interesting to see where this partnership takes the U.S. pharmaceutical industry in the future.

The Weinberg Group has a 35-year track record of helping our clients achieve successful interactions with the FDA and we have the experience you need to do exactly that.  Contact us today to learn more about our services and how we can help you develop and submit a successful application.

TAGS:

Regulatory Strategy in Pharma & Biotech Submissions Trial Design

Drug development can be a protracted and multifaceted process. This is often the case for startups and newer organizations, which may not have dedicated regulatory compliance departments and...

Meet the Expert: Steve Silverman

November 2, 2023

Meet the Expert: Steve Silverman

Expert Consultant, Regulatory Sciences Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a...

Doctor wearing lab coat and writing on clipboard at a desk in an office

March 25, 2024

Achieving Success with Regulatory Intelligence in Pharmacovigilance

What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...