The body is likely to be called the medical devices technical advisory board and would take a call on issues related to $3-billion medical devices sector in the country. This is likely to be part of an amendment to Drugs and Cosmetics Act, which is proposed to be introduced in the next session of Parliament.
Till date, select medical devices (those few that have been notified), even though fundamentally different in their specifications and functioning, are clubbed under the definition of drugs while remaining medical devices largely remain unregulated. This leads to problems with state drug regulators putting forth unreasonable demands, according to medical device manufacturers.
An orthopaedic implants company promoter, on condition of anonymity, told FE, Our state drug inspector kept insisting that orthopaedic implant factories install refrigeration units, just because pharma units are mandated to do so under Drugs and Cosmetics Act, even when there is no rationale behind such a demand.
Besides, the technical advisory committee said, the proposed new chapter on medical devices is likely to carry a new definition for medical devices and a risk-based classification. Hundreds of medical devices would be sorted into a four-graded classification.
All devices with a low-risk association such as thermometers would be categorised under class-A devices, devices with low to moderate risk such as suction equipment, hypodermic needle clubbed under class-B, a set of devices that are qualified as moderate to high-risk such as bone fixation plates, lung ventilators categorised as class-C and high-risk associated devices classified as class-D devices that may include heart valves.
The degree of regulation will be directly correlated to the risk involved that means class-D devices would be most heavily regulated, said an official in the know.
For the high-risk associated devices, some protocols on clinical trials may also be developed and violation on regulatory front may invite penalty provisions, which may be coded as well under law.
Specialised testing labs for medical devices and diagnostic kits are proposed to be set up, a health ministry official said adding that dedicated regulatory staff are proposed to be trained specially for medical devices.