NEW DELHI: Bringing ‘Make in India’ to the pharma sector, the government will come out with a Bill to regulate medical devices such as CT scanners, X-rays and stents to govern their standards and manufacture. This is expected to give a boost to the production of such devices in the country.
The decision was taken after representatives of the pharma sector met Prime Minister Narendra Modi and sought measures to boost the domestic manufacture of medical devices. A majority of such devices are imported. The Bill will be introduced in the next winter session of Parliament.
At the meeting, which was attended by senior officials of the Prime Minister’s Office, NITI Ayog and other departments, office bearers of top industry associations in the medical devices industry presented issues relating to ease of doing business, regulation, fiscal imperatives, scaling manufacturing, promoting exports and encouraging innovations, to make India an attractive destination for investments in the medical devices sector.
The draft of the Bill provides a first of its kind definition of medical devices, classifying them into devices which are used for medical investigations or tests and those which are used for other purposes. It also classifies devices as low-risk, moderate-risk and high-risk, and envisages creation of a separate body to grant licenses for their manufacture and import.
Low-risk medical devices will not require licences and certain rules for self-regulation would apply for their manufacture.