NPPA to monitor MRP of Pulse Oximeter, Oxygen Concentrators, asks manufacturers to submit price details
New Delhi: Through a recent memorandum, the National Pharmaceutical Pricing Authority (NPPA) has called upon the manufacturers and importers of Pulse Oximeter and Oxygen Concentrators to submit the Maximum Retail Prices (MRP) details in the prescribed format by 22nd May 2021 in order to monitor the price of the devices under DPCO, 2013.
The memorandum comes in reference to an earlier notice issued in March 2020 by NPPA for regulation of Medical Devices under Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955 w.e.f. 1st April 2020. According to this, the maximum retail price of medical devices can not be increased more than ten per cent (10%) in a year.
Under this provision, the MRP of the medical devices would be monitored, to ensure that no manufacturer/importer increases the MRP of a drug by more than 10% of the MRP during one year. If anyone does so, they would be faced with a penalty.
Medical Dialogues team had earlier reported that the Union Health Ministry had notified medical equipment used on humans or animals as "drugs" with effect from April 1, 2020.
With "Medical Devices" included in the definition of "drugs" under Section 3(b) of DCA, the Government is well empowered to declare Oxygen Concentrators, Pulse oximeters, and any other medical device as Essential Commodities under Entry 1 of the Schedule appended to Section 2A of The Essential Commodities Act (hereinafter referred to as "ECA") and regulate their prices.
Section 2A of ECA states that, for this Act, "Essential Commodity" means a commodity specified in the Schedule of ECA. Entry No. 1 to the Schedule annexed with Section 2A of the ECA includes "Drugs" as defined under Section 3(b) of The Drugs and Cosmetics Act, 1940 (hereinafter referred to as "DCA").
In the recent development, NPPA has directed all the manufacturers or importers of Pulse Oximeter and Oxygen Concentrators under Para 29 of the DPCO, 2013 to submit the MRP details in the prescribed format within 7 days i.e. latest by 22nd May 2021.
They have been instructed to submit a soft copy of the same to the following e-mail address: medicaldevices-nppa@gov.in
"In view of the above, all Manufacturers/Importers of aforesaid Medical Devices are also hereby advised to ensure compliance of the provisions of Para 20 of the DPCO, 2013 failing which action may be initiated for violation of provisions of DPCO, 2013 read with the Essential Commodities Act, 1955," the memorandum adds.
The aforesaid office memorandum has been forwarded to all manufacturers/importers of I Pulse Oximeters and (ii) Oxygen Concentrators, as well as Medical Devices Industry Associations of I Pulse Oximeters and (ii) Oxygen Concentrators, namely MTaI, AiMeD, CII, FICCI, USIBC, AMCHAM, AdvaMed, who are now required to distribute the Memorandum among their Member Companies and guarantee compliance.
Annexure-I Para 20 of DPCO, 2013: Format for Monitoring of MRPs of Medical Devices regulated as Drugs Name of the Company: Address of the Company: Contact Details: E-mail id: Category: Manfacturer/Importer Country of Import: | ||||||||||||
Sl No. | Medical Device Registration No. issued by CDSCO | Medical Device category as per the list issued by CDSCO | Product Name/ Specification as per DCGI approval/ Generaic Name | Brand Name | Type of Certification (If any, Please Specify) | Minimal Unit of Sale/ Retail pack size | Price to Distributor/ Stockist/Hospital (excluding applicable taxes) | Price to Retail (excluding applicable taxes) | Applicable GST % | Moving Annual Turnover (MAT)* (Rs. In Lakh) | Maximum Reatil Prices as on 1st May 2021 | Remarks |
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) | (12) | (15) |
Types: | ||||||||||||
Fingertip Pulse Oximeter | ||||||||||||
Table-top/Beside Pulse Oximeter | ||||||||||||
Hand-held Pulse Oximeter | ||||||||||||
Wrist-worn Pulse Oximeter | ||||||||||||
Paediatric Pulse Oximeter | ||||||||||||
Others (Please Specify) | ||||||||||||
* Moving Annual Turnover in a particular month means cumulative sales value for twelve months in domestic market, where the sales value of that month is added and the corresponding sales of the same month in the previous year are substracted. Signature of the Company Representative: Name of the Company Representative: Designation with office seal: Mobile No: E-mail id: | ||||||||||||
Annexure-II Para 20 of DPCO, 2013: Format for Monitoring of MRPs of Medical Devices regulated as Drugs Name of the Company: Address of the Company: Contact Details: E-mail id: Category: Manfacturer/Importer Country of Import: | ||||||||||||
Sl No. | Medical Device Registration No. issued by CDSCO | Medical Device category as per the list issued by CDSCO | Product Name/ Specification as per DCGI approval/ Generaic Name | Brand Name | Type of Certification (If any, Please Specify) | Minimal Unit of Sale/ Retail pack size | Price to Distributor/ Stockist/Hospital (excluding applicable taxes) | Price to Retail (excluding applicable taxes) | Applicable GST % | Moving Annual Turnover (MAT)* (Rs. In Lakh) | Maximum Reatil Prices as on 1st May 2021 | Remarks |
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) | (11) | (12) | (15) |
Types: | ||||||||||||
Portable Oxgen Concentrator | ||||||||||||
Stationary Oxgen Concentrator | ||||||||||||
Others (Please Specify) | ||||||||||||
* Moving Annual Turnover in a particular month means cumulative sales value for twelve months in domestic market, where the sales value of that month is added and the corresponding sales of the same month in the previous year are substracted. Signature of the Company Representative: Name of the Company Representative: Designation with office seal: Mobile No: E-mail id: | ||||||||||||
To view the official notice, click the link below:
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