NPPA extends timeline for trade margin capping of these 5 Medical Devices

The TMR was imposed in the wake of increased usage of these medical devices owing to C-19 pandemic.

NPPA Price of drugs

Last Updated on August 4, 2022 by The Health Master

The National Pharmaceutical Pricing Authority (NPPA) has notified its decision to extend the timeline for the trade margin capping of the five medical devices that are essential during the C-19 pandemic period till December 31, 2022.

The Authority said that it will monitor the trade margin rationalization and its implementation as per the provisions of the Drug (Prices Control) Order, 2013 (DPCO), subject to maintenance of the trade margin stipulated under the initial notification issued on July 13, 2021.

This is the second time the drug price regulator has extended the trade margin rationalization (TMR) of the following five devices at 70 percent at the first point of sale, following the initial notification on July 13, 2021:

  • Pulse oximeter,
  • Blood pressure monitoring machine,
  • Nebulizer,
  • Digital thermometer,
  • Glucometer

The TMR was imposed in the wake of increased usage of these medical devices owing to the C-19 pandemic.

It may be noted that in a meeting on June 28, the Authority deliberated upon the matter in detail and opined that as the C-19 pandemic is still a risk to public health, availability of these medical devices at affordable prices must be ensured.

“Hence, it was decided that the notification SO 2808(E) dated July 13, 2021, be further extended up to December 31, 2022, or until further orders, whichever is earlier,” said NPPA.

The notification enforcing the extension of TMR was issued on July 29, 2022.

The TMR, initially applicable up to January 31, 2022, was extended to July 31, in a notification at the end of January this year.

The notification mandated fixing the maximum retail price (MRP) as per the specified formula:

“Maximum Retail Price = Price to Distributor (PTD) + (PTD x TM) + Applicable GST, Where TM = Trade Margin not exceeding 70%.”

In pursuance of the price cap, the NPPA, through an office memorandum on July 14, also directed manufacturers and importers of these medical devices to submit revised MRPs of their products.

Based on the data provided, the downward revision of MRP was reported by imported and domestic brands across all the categories.

Also read related news: NPPA caps trade margin on Pulse Oximeter, Nebuliser, Digital Thermometer

Following this, a total of 1,132 products, including the following, have reported prices, of which 1,033 (91%) reported downward revision of MRP:

  • 277 pulse oximeters,
  • 329 blood pressure monitoring machines,
  • 105 glucometers,
  • 164 digital thermometers,
  • 257 nebulizers,

According to an earlier document with NPPA, the decrease in MRP was between:

  • Rs.12 to Rs. 2,95,375 (1%-89%) for pulse oximeters,
  • Rs. 20 to Rs. 38,776 (1%-83%) for blood pressure monitoring machine,
  • Rs. 30 to Rs. 2,250 (1%-98%) for glucometer,
  • Rs. 8 to Rs. 44,775 (1%-89%) for digital thermometer
  • Rs. 56 to Rs. 6,165 (1%-83%) for nebuliser.

The price regulator, through a notification on March 31, 2020, has brought all medical devices, including pulse oximeters, blood pressure monitoring machines, nebulizers, digital thermometers, and glucometers, to be governed under the provisions of DPCO, 2013 with effect from April 1, 2020.

Procedure to obtain license for manufacturing of Medical Devices

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

FAQs on Medical Devices Rules, 2017    

FAQs – on Blood Pressure Monitoring Devices

FAQs – on Blood Bags and its Testing

Medical Device Alert: Lists

Modified PLI scheme to promote manufacturing of Bulk Drugs

USFDA issues Form 483 for 3 observations to Aurobindo Pharma

Govt releases new National Standards for Blood Centres and Blood Transfusion

Drug prices: What is One-molecule, One-price policy ?

USFDA completes inspection of Casper Pharma with Zero Observations

AYUSH doctors can practise allopathy with own system: High Court

7,700 drug samples declared not of standard quality

USFDA gives nod for Diclofenac Sodium Topical Gel

USFDA gives nod for generic birth control pills

Latest Notifications regarding Pharmaceuticals

For informative videos on Medical Devices, click on the below YouTube icon:

YouTube Icon

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon
YouTube Icon

Enter your email address:

Delivered by FeedBurner