Lakshmi Kumaran & Sridharan AttorneysAn ISO 9001 / 27001 certified law firm

Implantable medical devices will now be drugs


29th June, 2018

The Central Drugs Standard Control Organization (CDSCO) on June 22, 2018 issued a public notice regarding medical devices. Through the notice, the CDSCO has proposed to include implantable medical devices within the purview of Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 (the Act), and now would be considered as ‘drugs’. This proposal was recommended by the Drug Technical Advisory Board (DTAB) in their recent meeting. In addition to implantable medical devices, the notice also proposes to include CT scan equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-Ray machine and bone marrow cell separators within the scope of section 3(b)(iv).

‘Implantable medical devices’ although not defined in the Act, are defined in the Fifth Schedule of the Medical Devices Rules, 2017 (Rules) and include medical devices that are intended to be totally or partially introduced into the human or animal body or a natural orifice or to replace an epithelial surface or the surface of the eye. In order to qualify as an ‘implantable medical device’ such a device should remain within the human or animal body for a period of at least 30 days, and is capable of being removed only through medical or surgical intervention.

Few examples of such devices include pacemakers, and cochlear implants.The Central Government, through previous notifications, has so far notified about 22 devices which are included within the scope of a ‘drug’, as defined by the Act. It is interesting to note that the list of the notified medical devices notified thus far, only included specific types of implantable medical devices, such as stents and orthopaedic implants.

The present proposal, if accepted, will be a major change which will bring all types of implantable medical devices within the purview of the Act. The implantable medical devices may further be active or non-active. Active implantable medical devices have been defined as implantable medical devices which require a source of electrical energy to operate.

Examples of such types of devices may include, but may not be limited to, pacemakers and certain types of cochlear implants. The global implantable medical devices market is anticipated to grow with a CAGR of 7.45% between 2016-2023 and is expected to touch USD 117 billion by 2023 with most projected growths arising out on Indian and Chinese markets.

The present proposal when accepted may well bring implantable medical devices within the regulatory framework as prescribed by the Act. Furthermore, subsequently, such implantable medical devices may also be subsequently brought within the purview of Drug Price Control Orders (DPCO) notified by the Department of Pharmaceuticals in 2013 to provide a pricing mechanism for such implantable medical devices. Even the prices of the other devices, i.e., CT scan equipment, MRI equipment, etc., listed in the present notice is also likely to reduce, which in turn may result in the cost benefit being passed, in the long run, on to the customers who avail such facilities in hospitals/medical institutions.

The CDSCO has presently invited comments and suggestions from various stakeholders. Subsequently, the notice would be published in the official Gazette of India. Although the notice will take effect only after 12 months from its date of publication in the Gazette, it is definitely a positive step towards making medical care and services more affordable to the public at large.
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