India’s Ministry of Health Agrees to Regulate Medical Devices and Drugs Independently

In December 2015, India’s Ministry of Health agreed to institute new regulations that would separate the laws governing medical devices and pharmaceuticals. The proposed changes will also require new safety and efficacy tests to ensure that devices produced in India meet international standards. According to the Association of Indian Medical Device Industry, the legal separation between drugs and devices will encourage foreign companies to invest in Indian medical devices. Previously, potential investors were discouraged due to complex laws that saw certain devices regulated as drugs while others were regulated as devices. While this agreement does not legally change the regulations, it is viewed as a positive step towards developing a regulatory framework that is more aligned with international standards.