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National Pharmaceutical Pricing Authority

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eMediNexus    01 March 2018

Sub: Monitoring of price movement of notified medical devices as Drugs under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945

Para 20 (I) of the DPCO, 2013 provides for monitoring the Maximum Retail Prices(MRPs) of all the drugs, including the non-scheduled formulations in order to ensure that nomanufacturer/importer increases the maximum retail price of a drug more than ten percent ofmaximum retail price during preceding twelve months and where the increase is beyond tenpercent of maximum retail price, it shall reduce the same to the level of ten percent ofmaximum retail price for next twelve months. As per para 20(2), the manufacturers/importershall be liable to deposit the overcharged amount along with interest thereon from the date ofincrease in price in addition to the penalty.

National Pharmaceutical Pricing Authority

In order to monitor the price movement of 19 medical devices out of 23 medical devices notified as drugs under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, NPPA vide its Office Memorandum dated 12th May, 2017 directed all Medical Device Manufacturers/importers /marketers / Associations to submit data as per the prescribed format in respect of all the 19 medical devices by 31 May, 2017. However, the deadline for submitting the data was extended up to 09th June, 2017 vide OM dated 01St June, 2017.

It has been observed that many manufacturers/ Importers have not submitted the requisite price data in prescribed format in respect of medical devices as per annexure. The manufacturers/importers who have not submitted the data so far are hereby given a last opportunity to submit the requisite data as per prescribed format in respect of Medical Devices as per Annexure by March 15, 2018.

They are also required to send hard copy of the data as per attached format to NPPA by March 15, 2018.

The hard copy should be duly signed by the authorized representative of the companies with official seal giving details about the name of person, designation, mobile number and email id. Copies of the license issued by Drug Controller General of India for each medical device must be attached along with the data. A soft copy of the data and license may be sent through email to jp.ray89(agov.in .

The DPCO, 2013 has been issued by the Central Government in exercise of the powers conferred by Section 3 of the Essential Commodities Act, 1955 and any contravention of the provision of the DPCO, 2013 is punishable in accordance with the provisions of the Essential Commodities Act, 1955.

All manufacturers/importers of medical devices are advised to ensure compliance of provisions of DPCO, 2013 to avoid action against any violation under the provisions of DPCO, 2013 read with Essential Commodities Act, 1955. Failing compliance by manufacturers/ importers, NPPA may request CDSCO to revoke the manufacturing/ import licenses issued, apart from taking legal follow up action under Para 29 & 30 of DPCO, 2013 and also under Essential Commodities Act.

The following notified medical devices are considered as drugs under Drugs and Cosmetics Act.

  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 Cannula
  8. Bone Cements
  9. Heart Valves
  10. Scalp Vein Set
  11. Orthopedic Implants (Hip Implants)
  12. Internal Prosthetic Replacements (Dental Implants, Cochlear Implants etc.) The following products are also regulated as drugs under Drugs and Cosmetics Act.
  13. Blood Grouping Sera
  14. Ligatures, Sutures and Staplers
  15. Tubal Rings
  16. Surgical Dressings
  17. Umbilical Tapes
  18. Blood/Blood Component Bags.
  19. Ablation Devices
                                                                                                                                                                                                                                                    ANNEXURE

Format for Collecting  Data on Medical Devices for Monitoring

Name of the Medical Device: 

Name of the Manufacturer/Importer with address, contact Numbers and Email id:______

Prod-uct Name/Speci-fica-tion as per DCGI ap-proval
Product name/brand and other speci-fications relat-ing to its mate-ri-al/size/application or any other specification.
Date of launch in India
Min-imal Unit of Sale/ Re-tail pack size
Price to Stockist/ Distribu-tor (ex-cluding local taxes) as on April 1st, 2017
Price to Re-tail-ers/ Hos-pitalsas appli-cable (Ex-clud-ing local taxes) as on April, 1st 2017
Appli-cable VAT rate
Mov-ing Annual turno-ver (MAT) *(₹ in lakhs)
MRP (year to year in the last four years) Inclusive of all Taxes

(As on April 1st)

Re-marks if any
2014
2015
2016
2017
1
2
3
4
5
6
7
8
9
10
11
12
13
* 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.

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