A comprehensive regulatory framework for the medical devices sector is being planned with the authorities set to issue a new set guideline to treat medical devices as a separate category and to put in place new definition for the same. The sector has remained unregulated for several years due to many factors including lack of clarity in policies.
The draft guidelines, finalised in consultation with the industry through a series of meetings in the past, have already been approved by the DTAB recently and will be issued soon by the health ministry. The guidelines mainly seek to keep the medical devices separate from the new drugs and to be placed under stricter monitoring by the DCGI office. The guidelines will be binding on both the manufacturing and import of medical devices, it is learnt.
The DCGI office has already issued several notices in the recent past to streamline the sector by asking the industry to go strict on medical devices. Besides, the office also had expanded the list of medical devices, by including 19 more items to the list already in force since 2005.
Spinal needles, insulin syringes, three-way stop cock as an accessory of IV cannula/catheter/perfusion set, endotracheal tubes, introducer sheath, annuloplasty righ, cardiac patch, cochlear implant, extension tube, close wound drainage set, trachestomy tube with or without cuff, AV fistula needle, extension line as an accessory of infusion set, ANGO kit/cath lab kit, heart lung pack, measure volume set, flow regulator, haemodialysis tubing set and dialysis catheter were thus brought under the purview of the Act recently. Cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants, and internal prosthetic replacements had been brought under the purview of Drugs and Cosmetics Act, making it mandatory to get licence for manufacture for sale and distribution in 2005.
The DCGI had set up a committee involving representatives of trade bodies including FICCI and CII to draft the guidelines and have gathered inputs from the industry as whole also by inviting public opinion on the same. Besides, the WHO and the US FDA have been assisting the DCGI office to float the new guidelines and train the staff at the headquarters. The DCGI office already has a separate wing to deal with the applications, monitoring and other related tasks about medical devices.