Imported first-aid kits meant only for workplace use in sectors such as automobiles and hospitality could skip import licensing if they carry at least 60% residual shelf life.
New Delhi: The Drugs Technical Advisory Board (DTAB) has recommended relaxing sale and import licence requirements for a set of medical devices commonly used at home, including pulse oximeters, blood pressure monitors, thermometers, glucometers and urine pregnancy test kits, according to a report in Outlook India.
The recommendations were made at the board’s 94th meeting and cover products that consumers generally use directly or that serve limited, non-commercial purposes, the report said. Small quantities of devices brought into the country for display and demonstration at exhibitions are also part of the proposal.
At present, the Eighth Schedule of the Medical Devices Rules, 2017 lists device categories exempt from Chapter XI, which includes the requirement of a sale licence. The existing entry covers certain medicated dressings and bandages meant for first aid, provided they are made by licensed manufacturers. DTAB has suggested widening this entry to first-aid kits containing items such as bandages, cotton gauze, resuscitation masks, adhesive tape, thermometers, absorbent cotton wool and adhesive plaster, according to the report.
A separate recommendation deals with imported first-aid kits bought by non-healthcare industries, such as automobile companies and the hospitality sector, for their own use. The board said such kits could be exempted from the import licence requirement under Chapter V of the rules as well as the sale licence requirement under Chapter XI, citing ease of doing business. According to the meeting minutes, the aim is to ease “the process of import” of these kits.
The relief for imported kits would come with safeguards. The kits must have at least 60% of their shelf life remaining at the time of import, meet applicable standards and be used strictly for captive consumption, with resale or onward distribution not permitted, the report said.
The proposals had earlier been taken up by the Medical Device Technical Advisory Group (MDTAG) at its meeting on 14 May 2026. The Eighth Schedule already exempts devices supplied by government and local-body hospitals and dispensaries, mechanical contraceptives under set conditions, and small quantities of devices donated to charitable hospitals for free treatment, the last subject to a no-objection certificate from the Central Licensing Authority.
The report noted that the changes would widen an existing exemption framework rather than take the devices out of regulatory oversight, since the exemptions continue to operate under conditions prescribed in the rules. It did not give a timeline for notification.
Source: Outlook India, 28 September 2026
