The Department of Pharmaceuticals (DoP) has initiated a comprehensive stakeholder consultation process to amend its medical device exemption list. According to reports from Business Standard, the department met with domestic and multinational industry stakeholders to seek suggestions regarding additions and deletions to the existing list. In a public notice dated June 22, the DoP stated it has received representations to include more than 350 devices in the list, along with requests to remove 235 devices.
The department has now sought final comments from domestic players, importers, industry associations, procurement agencies, healthcare institutions and other interested parties by July 15. As reported by Business Standard, stakeholders have been asked to furnish relevant supporting information on the availability or non-availability of domestic manufacturing capacity, details and number of such domestic manufacturers and importers. Industry executives have also been told to share annual production and domestic supply capacity for any devices to be added or removed, along with import dependence and availability of alternative sources.
The existing list of 354 medical devices was released in February and allows government bodies to procure by bypassing the local procurement clause for essential advanced technology not readily available in India. According to Business Standard, under the DoP's Public Procurement (Preference to Make in India) Order, 2017, public procurement agencies are directed to prioritise purchasing pharmaceutical formulations from local suppliers. Class-I suppliers must have 80 per cent or more local content, while Class-II suppliers require local content of 50 per cent to less than 80 per cent.
The Department of Expenditure under the Union Finance Ministry had amended the General Financial Rules, 2017, empowering concerned ministries or departments to seek tenders globally through GTEs. As reported by Business Standard, the amendment states that no GTE shall be invited for tenders up to ₹200 crore or such limits as may be prescribed from time to time. However, in exceptional cases where the ministry or department feels there are special reasons for GTE, it may record detailed justification and seek prior approval for relaxation of the rule for tenders below such limits.
According to a medtech executive quoted by Business Standard, the government will be looking at the likely impact of added or removed devices on public procurement, patient access, availability, affordability and quality of healthcare services. The industry executive noted that the list was in limbo for over a year due to confusion over the effects of US tariffs on medical devices. With the trade deal agreed upon, the department may find it easier to finalise the GTE exemption list.
