National Pharmaceutical Pricing Authority (NPPA), a regulatory body under Department of Pharmaceuticals, Government of India, is authorized to fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country under Drug Price Control Order (DPCO), 2013.

Whereas the NPPA has fixed the prices of some medical devices such as coronary stents and knee implant system. Further in larger public interest, uninterrupted supply of these medical devices will also be ensured by the government. In this context, the Department of Pharmaceuticals (DoP), Indian government has invoked the powers under paragraph 3 of Drugs Prices Control Order (DPCO), 2013 to ensure the compliance of price capping of medical devises with maintaining its uninterrupted supply.

Paragraph 3 of DPCO, 2013 prescribes that "the government may (i) with a view to achieve adequate availability and to regulate the distribution of drugs, in case of emergency or in circumstances of urgency or in case of non-commercial use in public interest, direct any manufacturer of any active pharmaceutical ingredient or bulk drug or formulation to increase the production and to sell such active pharmaceutical ingredient or bulk drug to such other manufacturer(s) of formulations and to direct formulators to sell the formulations to institutions, hospitals or any agency as the case may be;

(ii) for the purpose of giving any direction under sub-paragraph (i), call for such information from manufacturers of active pharmaceutical ingredients or bulk drugs or formulations, as it may consider necessary and such manufacturer shall furnish the required information within such time the Government may fix."

On September 18, 2017, through its notification, Department of Pharmaceuticals (DoP), Indian Government has advised Knee Implant manufacturers and importers to ensure compliance to the price capping of the Primary Knee and Revision Knee along with maintaining uninterrupted supply.

The companies are also directed to:

  1. Furnish the production figures for 2015-16, 2016-17, and 2017-18;
  2. To maintain production/ import/ supply of the orthopedic knee implant systems at the same levels before August 2017, and
  3. To submit a weekly report on orthopedic knee implant systems produced and distributed14.

Similarly, on September 27, 2017, through its notification, Department of Pharmaceuticals (DoP), Indian Government has advised 62 coronary stent manufacturers to ensure compliance to the price capping of the coronary stent along with maintaining uninterrupted supply.

The Companies manufacturing coronary stent in India are also directed to:

  1. Maintain production/ import/ supply of coronary stents
  2. To submit a weekly report on coronary stents produced and distributed. They will also submit a weekly production plan for the next week to NPPA and DCGI.

This order will be valid for next three month from the date of notification (except for absorb classic BVS and Absorb GTI BVS stent of M/s Abbott Healthcare) and NPPA and DCGI will recommend withdrawal or extension as the case may be. NPPA and Drug Controller General of India (DCGI) are also empowered to extend these directions to any other producers of coronary stents in India during this three-month period15.

Footnotes

14. http://pharmaceuticals.gov.in/sites/default/files/implants%20para%203%20order.pdf

15. http://pharmaceuticals.gov.in/sites/default/files/Para%203%20order%20dated%2027-09-2017.pdf

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