NPPA Extends Timeline For Trade Margin Capping Of Five Medical Devices

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

The Authority said that it will monitor the trade margin rationalisation and its implementation as per the provisions of the Drug (Prices Control) Order, 2013, subject to maintenance of 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 rationalisation (TMR) of the five devices- pulse oximeter, blood pressure monitoring machine, nebuliser, digital thermometer and glucometer – at 70 per cent at first point of sale, following the initial notification in July 13, 2021.

The TMR was imposed in the wake of increased usage of these devices owing to Covid-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 Covid-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 upto 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 upto January 31, 2022, was extended to July 31, in a notification in has in the end of January, this year.

The notification mandated to fix 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%.”

NPPA, through an office memorandum on July 14, also directed manufacturers and importers of these medical devices to submit revised MRPs of their products, in pursuance to the price capping. Based on the data provided, the downward revision of MRP was reported by imported and domestic brands across all the categories.

Following this, a total of 1,132 products, including 277 pulse oximeters, 329 blood pressure monitoring machines, 105 glucometers, 164 digital thermometers and 257 nebulisers have reported prices of which 1,033 (91%) reported downward revision of MRP. 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 and Rs. 56 to Rs. 6,165 (1%-83%) for nebuliser, according to an earlier document with NPPA.

The price regulator, through a notification on March 31, 2020 has brought that all medical devices including pulse oximeter, blood pressure monitoring machine, nebuliser, digital thermometer, and glucometer, to be governed under the provisions of DPCO, 2013 with effect from April 1, 2020.

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