NPPA to regulate MRP of non-scheduled medical devices, asks manufacturers to submit price details

NPPA has rolled out a memorandum directing all non-scheduled medical device manufacturers and importers to mandatorily submit the price list and supplementary price list in a given format to the dealers, State Drug Controllers, and the Government.

The manufacturers or importers of all 24 non-scheduled Medical Devices are bound to submit price-related information in the given prescribed formats within 21 days ie. before March 9, 2021. In a directive on February 16, NPPA said,

"In exercise of powers of Para 29 of the DPCO, 2013 hereby directs all manufacturers/importers of all the 24 (20+4) non-scheduled Medical Devices (Annexure-I & II) to submit price-related information in the prescribed formats (Annexure-III & IV), duly certified by practicing Chartered/Cost Accountant, within 21 days of issue of this O.M."

Currently as per the Drug and Cosmetics Act, 1940 there are 28 categories of Medical Devices, regulated as "Drugs" among which 4 devices are categorized as scheduled Medical Devices. These 4 scheduled Medical Devices include Coronary Stents, Drug-Eluting Stents, Condoms, and Intra-Uterine Devices. While the prices of four categories of medical devices are already fixed by NPPA, the prices of the rest are fixed by the manufacturers themselves. The authority now seeks to monitor the price movement of all 24 categories of medical devices. The list of 24 non-scheduled Medical Devices reads;

List of Medical Devices notified/ regulated as "Drugs" under Drug & Cosmetics Act, 1940