India and US to Regulate Medical Products in India

The Drug Controller General of India (DCGI) and the US FDA have recently held talks on regulating medical devices, monitoring adverse events, and increasing cooperation between the two nations. Though drug regulations have been in place in India for over 50 years, medical devices have only been regulated recently.

The two nations plan to set up working groups to help create a US FDA-style agency with regulatory authority over medical devices. These working groups would provide technical support to establish quality standards, identify key areas of quality concern, and ensure the safety of products. Other goals include developing a more comprehensive online system for approvals, warnings, and recalls. The five main areas the two nations will focus on are medical devices, biological drugs, clinical practices, pharmacovigilance, and systems to facilitate online submissions.

The US FDA has also started to conduct surprise inspections of its approved facilities in India. Previously, the US FDA would give prior notice and a detailed schedule for audits. However, when conducting surprise inspections, it usually gives only two or three days’ notice.

As with China, the US FDA is also planning to open offices in India by next year. Planned locations for its offices include Delhi, Mumbai, and Hyderabad.