Separate Medical Device Regulation in the Works for India

India’s government is working on a comprehensive regulatory framework for the medical device sector, which has been lacking a formal regulatory system for many years. Medical devices are currently often regulated as drugs or unregulated. Now, however, India’s health authorities plan to issue a new set of guidelines to define and regulate medical devices as a separate category. These guidelines are being finalized in consultation with the device industry and public opinion, and should be issued soon by the health ministry.

The new guidelines primarily separate medical devices from drugs and call for stricter oversight from the Drug Controller General of India (DCGI) on both the manufacturing and import of medical devices. The DCGI currently has a separate wing to deal with medical device applications and monitoring, but this will likely need to expand after the publication of the medical device regulatory framework.

The DCGI has also recently included 19 more medical devices under the regulation of the Drugs and Cosmetics Act (DCA). Devices that now require a license for distribution and sale include the following: spinal needles, insulin syringes, endotracheal tubes, cochlear implants, annuloplasty rings, trachestomy tubes, heart lung packs, measure volume sets, hemodialysis tubing sets, blood tubing sets, dialysis catheters, etc. Devices that have been regulated by the DCA since 2005 include heart valves, cardiac stents, orthopedic implants, and internal prosthetic replacements.