‘Too many departments are involved in approvals. We want to hasten the process.’

To eliminate bottlenecks in domestic medical devices businesses the Government Think Tank Niti Aayog draws up list of medical devices that have high export potential. It has come up with 10 devices to provide priority subsidies. It includes surgical blades, orthopaedic implants catheters, syringes and needles, X-ray machines, blood bags, MRI machines and CT scan.

The devices included in the list are to be prioritized in order to boost their domestic manufacturing and export. However, more devices are expected to be added in follow-up meetings. This is a preliminary list,” an official, who was present at a meeting called by NITI Aayog said to a local newspaper.

The meeting was chaired by VK Saraswat, Member, Science and Technology, NITI Aayog, who said that the government was looking at a single window framework for accelerating standardisation, body certification, declaring the device safe and so on. “Currently there are too many departments involved in giving approvals, and thus they get delayed. We want to hasten this process,” Saraswat said.

Earlier, In December 2018, NITI Aayog announced that all medical devices will be brought under one regularity regime. This will aid in boosting the export as well as it will fasten the certification process.

Currently the medical devices are governed under the Central Drugs Standard Control organizations. It is a statutory body that was created under Drugs and Cosmetic Act. The Government of India suggested to bring all the medical devices under the body.

 However NITI Aayog turned down the proposal and suggested the creation of National Register of Medical Devices. According to NITI Aayog, it will act as an autonomous body on the lines of FSSAI. The body will have device experts and IIT labs will be used for testing the devices.   

  medical