NPPA seeks details of price movement of certain ortho implants

The national drug price regulator, NPPA, has sought details from some medical device companies regarding the price movement of certain orthopaedic implants in last three years.
While rejecting the contention of these firms that medical devices are not covered by the provisions of Drug Prices Control Order (DPCO), 2013, National Pharmaceutical Pricing Authority (NPPA) has given them a week to respond.
"This is with reference to clarification sought by some companies regarding applicability of the provisions of DPCO, 2013 in case of medical devices," NPPA said.
In its earlier letter dated May 15, 2015, it had clarified that Para 20 of DPCO, 2013 provides for monitoring of the non-scheduled formulations.

"Orthopaedic implants along with other medical devices are notified as 'Drug' under the Drugs and Cosmetics act 1940 and rules thereunder. Therefore, your contention that the provisions of DPCO, 2013 are not applicable to medical devices is totally incorrect," the letter said.
Para 29 of DPCO, 2013 empowers the government to call for any record and to inspect such report at the premise of manufacturers relating to sales of formulations, which includes 14 notified medical devices, NPPA said.
Accordingly, it has been decided to seek information regarding the price violation, if any, in respect of notified medical devices manufactured/ imported/ marketed by the company, NPPA said, seeking the product specification for different types of notified medical devices manufactured or imported by the company.

It has also sought ex-factory price/ landed cost including duties of the orthopaedic implants, distributor cost and MRP along with percentage increase in MRP in the last three years.