FDA Brief: Week of Feb 22, 2016
Strengthening Regulatory Relationships in India
By: Mathew T. Thomas, Director, and Dean Rugnetta, Deputy Director, FDA’s India Office, New Delhi, India
- India is one of the largest suppliers of drug products to US
- FDA India office established in 2008 to promote govt. -to-govt. interactions
- Working with counterparts in Indian government to ensure manufactured medical products meet FDA’s safety and quality requirements
- Meeting of India and US offices held in Nov. 2015 to learn respective regulatory perspectives
- Continue leveraging knowledge and strengths to ensure patient safety in India and product quality of FDA-regulated pharmaceuticals.