The Central Drug Standards Control Organization (CDSCO) is India's main regulatory body for pharmaceuticals and medical devices. ... In India, the manufacturing, import, sale, and distribution of medical devices are regulated under India's Drugs & Cosmetic Act and Rules (DCA). The recent global investigation- Implant Files- by International Consortium of Investigative Journalists (ICIJ) shows that the Centre is reluctant to regulate the medical device industry. The recent global investigation – Implant Files – by International Consortium of Investigative Journalists (ICIJ), which portrayed the sorry picture of India’s medical devices industry, points to the need to have a strong legislation in this sector. Though India’s medical devices market has become the hub of global majors like Medtronic, Stryker, Abbott, Bayer and Johnson & Johnson, a legislation for the comprehensive regulation of the sector, the Medical Device Regulation Bill, was brought only in 2018. The Bill had been drafted in 2006 by the then UPA government. Following that, under the current NDA government, a Group of Ministers (GoM) was constituted under the Union Finance Minister Arun Jaitley. However, the GoM had postponed the legislation, and had introduced the Medical Device Rules and Regulations. The new set of rules was released in 2017, and notified on January 1, 2018.