Task force for price control order for medical devices

Even as the government is mulling regulating medical devices sector, a task force has recommended a separate price control order by putting them under the Essential Commodities Act.
Once the devices come under the purview of the Act, the government can keep a tab on prices of equipment.
The Task Force on Medical Devices constituted under the Chairmanship of Secretary, Department of Pharmaceuticals, has also recommended formulation of the 'Medical Device Regulatory Act'.
"...The medical devices may be included separately from drugs in the Essential Commodities Act and regulated under a separate Medical Devices (Price Control) Order (MDPCO)..," it added.

The committee also underlined that drug price regulator NPPA should be empowered for fixation and monitoring of prices of medical devices under a separate vertical.
"..It should be done in such a manner to ensure sufficient incentives in terms of returns on investment," the report said.

While releasing the report last week, Fertilisers Minister Ananth Kumar had stated that the government was looking at mooting a bill in Parliament for regulation of medical devices in India.
The report noted that pricing policy for medical devices should be 'transparent' and based on core principle of 'value for money'.
There should be a regulatory body for medical devices and all regulatory clearances to be provided by single window, it recommended.

To ensure 'Make in India' becoming a success in the sector, the task force has emphasised that tax/duty structure to be designed to promote local manufacturing of quality medical devices and diagnostic equipment.
It has advocated for minimum-zero duty on import of raw materials and manufacturing equipment for production of medical devices and at the same time demanded for restrictions on import of second hand diagnostic equipment.
The government is also planning to set up two medical devices parks in the country to raise its indigenous production.
In December last year, the Cabinet approved amendment of FDI policy in pharmaceutical sector and carved out medical devices segment from it while allowed 100 per cent foreign direct investment under automatic route.