Lok Sabha Question No. 66 (STARRED), answered on 2017-02-07
Subject: Regulation of Prices of Cardiac Stents
Ministry: CHEMICALS AND FERTILIZERS
Asked by: VIJAY KUMAR S.R., KUNWAR HARIBANSH SINGH

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS & FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

## LOK SABHA

STARRED QUESTION NO. *66

TO BE ANSWERED ON 07 th  February, 2017

## Regulation of Prices of Cardiac Stents

- *66. SHRI S.R. VIJAYAKUMAR: KUNWAR HARIBANSH SINGH:

## Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the National Pharmaceutical Pricing Authority (NPPA) is working out a formula to regulate the prices of different cardiac stents;
- (b) if so, whether the NPPA has invited stakeholders for discussions and suggestions in this regard;
- (c) if so, the details and the outcome thereof;
- (d) the  prevailing  price  of  cardiac  stents  manufactured  in  the  country  as  well  as  imported stents; and
- (e) the  steps  taken/being  taken  by  the  Government  to  produce  better  quality  and  cheaper cardiac stents in the country?

## ANSWER

## MINISTER   IN   THE   MINISTRY   OF   CHEMICALS   &   FERTILIZERS AND PARLIAMENTARY AFFAIRS (SHRI ANANTH KUMAR)

- (a) to (e): A statement is laid on the Table of the House.

## Statement  referred  to  in  reply  to  Lok  Sabha  Starred  Question  No.  *66  for  answer  on 07/02/2017 regarding Regulation of Prices of Cardiac Stents.

- (a) & (b): The  coronary  stents  have  been  included  in  the  First  Schedule  of  Drugs  (Prices Control)  Order  2013  (DPCO,  2013)  vide  notification  dated  21 st December  2016.  National Pharmaceutical  Pricing  Authority  (NPPA)  is  mandated  to  fix  the  ceiling  prices  of  Coronary stents (as per the provisions of DPCO, 2013).

NPPA has undertaken an elaborate exercise of consultation with stakeholders, collection of data from all stakeholders and from central government agencies and has displayed the draft versions (different  options)  of  price  calculation  of  proposed  prices  for  coronary  stents  on  its  website, http://www.nppaindia.nic.in/, and sought suggestions from stakeholders.

- (c): Some  manufacturers/suppliers  have  suggested  fixation  of  separate  ceiling  prices  for additional  sub-categories  of  stents  and  for  using  Price  to  Hospital  (PTH)  data  as  basis  for working out the ceiling price of coronary stents which has been opposed by some civil society groups.
- (d): There is a wide range of Cardiac Stents manufactured in the country, as well as imported into the country. As per information provided to NPPA by domestic manufacturers and importers of coronary stents, the minimum and maximum MRP of coronary stents is as follows:-
- (e): The  Government  after  exhaustive  stakeholder  consultations  has  notified  the  Medical Devices  Rules,  2017  on  31/01/2017.  This  will  help  in  streamlining  the  quality  management protocol for manufacture of medical devices and remove  a major hurdle to domestic manufacturers of medical devices including coronary stents.

| Sr. No.   | Stents                                                                |          | Minimum      | Maximum       |
|-----------|-----------------------------------------------------------------------|----------|--------------|---------------|
| 1.        | Bare Metal Stents                                                     | Domestic | Rs. 25000 /- | Rs. 75000 /-  |
|           |                                                                       | Imported | Rs. 30000 /- | Rs. 50000 /-  |
| 2.        | Drug Eluting Stents                                                   | Domestic | Rs. 55000 /- | Rs. 195000 /- |
|           | including Bioresorbable Vascular Scaffold (BVS)/ Biodegradable stents | Imported | Rs. 40000 /- | Rs. 198000 /- |

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