Medical devices rules notified on Jan 31: Ananth Kumar

New Delhi : Government has notified a bill related to manufacturing of medical devices, including coronary stents, in the country in order to streamline the quality issues, Parliament was informed.

"The government after exhaustive stakeholder consultations has notified the Medical Devices Rules, 2017 on January 31, 2017," Union Chemicals and Fertilisers Minister Ananth Kumar said in a written reply to the Lok Sabha.

This will help in streamlining the quality management protocol for manufacture of medical devices and remove a major hurdle to domestic manufacturers of medical devices including coronary stents, he added.

The coronary stents have been included in the First Schedule of Drugs (Prices Control) Order 2013 (DPCO 2013) vide notification dated December 21, 2016 and the NPPA is mandated to fix the ceiling prices of coronary stents, he added.

The minister said that some manufacturers have suggested fixation of separate ceiling prices for additional sub-categories of stents and for using price to hospital data as basis for working out the ceiling price of coronary stents which has been opposed by some of the civil society groups.

There is a wide range of cardiac stents manufactured locally as well as imported into the country.

As per information provided to NPPA, the cost of stents in the country ranges between Rs 25,000 to 1.98 lakh, Kumar said.