NPPA to regulate MRP of non-scheduled medical devices, asks manufacturers to submit price details
New Delhi: In a major development regarding medical devices, the National Pharmaceutical Pricing Authority (NPPA) has decided to monitor and regulate the Maximum Retail Price (MRP) of Medical Devices notified as Drugs under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. For this, the Authority has given three weeks' time to manufacturers and importers of 24 categories of medical devices to furnish pricing details of all such products.
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
SI No. | Names of Medical Devices category notified/regulated as 'Drugs' | MRP as on 1rst January 20 18, 20 19, 2020 and 2021 along with relevant enclosures in the prescribed format duly signed and verified by practicing CA/CMA. |
1 | Disposable Hypodermic Syringes | |
2 | Disposable Hypodermic Needles | |
3 | Disposable Perfusion Sets | |
4 | In vitro Diagnostic Devices of HIV, HBsAg and HCV | |
5 | Catheters | |
6 | Intra Ocular Lenses | |
7 | I.V Cannulae | |
8 | Bone Cements | |
9 | Heart Valves | |
10 | Scalp Vein Set | |
11 | Orthopedic Implants | |
12 | Internal Prosthetic Replacements | |
13 | Ablation Devices | |
14 | Organ Preservative Solution | |
15 | Blood Grouping Sera | |
16 | Ligatures, Sutures and Staplers | |
I 7 | Tubal Rings | |
I 8 | Surgical Dressings | |
I 9 | Umbilical Tapes | |
20 | Blood/Blood Component Bags |
SI No. | Names of Medical Devices category notified/regulated as 'Drugs' | MRP as on 1st January 202I along with relevant enclosures in the prescribed format duly signed and verified by practicing CA/CMA. |
1 | Nebulizer | |
2 | Blood Pressure Monitoring Machine | |
3 | Digital Thermometer | |
4 | Glucometer |
The Maximum Retail Prices (MRP) of non-Scheduled Medical Devices notified as 'drugs' under Drugs and Cosmetics Act,1940 are governed under the provisions of Para 20 of the Drugs(Price control) Order, 2013. By implementing the Para 20 provision of the DPCO, 2013, dated 12th May 2017, all the price-related data had been gathered for all the 19 categories of non-scheduled Medical Devices for the years from 2014 to 2017.
Moreover, the Ministry of Health & Family Welfare had added four more Medical Devices including Nebulizer, Blood Pressure Monitoring Machine, Digital Thermometer, Glucometer under the category of non-scheduled Medical Devices, regulated as "Drugs" with effect from 01.01.2021.
