Lok Sabha Question No. 2781 (UNSTARRED), answered on 2018-03-13
Subject: Guidelines by NPPA
Ministry: CHEMICALS AND FERTILIZERS
Asked by: VIJAYSINH MOHITE PATIL, SUPRIYA SADANAND SULE, HEENA VIJAYKUMAR GAVIT, P.R. SUNDARAM

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

LOK SABHA UNSTARRED QUESTION NO. 2781

TO BE ANSWERED ON 13 th  March, 2018

## Guidelines by NPPA

## 2781.  SHRI MOHITE PATIL VIJAYSINH SHANKARRAO:

SHRIMATI SUPRIYA SULE:

DR. HEENA VIJAYKUMAR GAVIT:

SHRI P.R. SUNDARAM:

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

- (a) whether patients are charged inordinately high amount for the stent device and if so, the details thereof;
- (b) whether  the  National  Pharmaceutical  Pricing  Authority  (NPPA)  has  made  it mandatory for hospitals to disclose the cost of the stent separately while billing a patient and if so, the details thereof;
- (c) whether  the  NPPA  has  marginally  increased  the  cost  of  basic  cardiac  stents while reducing the prices of  expensive stents and if so, the details thereof;
- (d) whether the Government has consulted all the stakeholders before arriving at the price and if so, the details thereof;
- (e) whether  the  NPPA  has  also  made  it  mandatory  for  the  hospitals  to  provide  a clear breakup of the prices levied for other items used in medical procedures and if so, the details thereof; and
- (f) the steps the Government has taken to regulate and control the price of stent and make it accessible to the needy and poor patients?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY  OF  SHIPPING  AND  MINISTRY  OF  CHEMICALS  AND  FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (a): National  Pharmaceutical  Pricing  Authority  (NPPA)  vide  its  notification  S.O. 412(E)  dated  13 th February,  2017  fixed  the  ceiling  price  of  the  coronary  stents. Institutions such  as hospitals/nursing homes/clinics utilizing Coronary  Stents for angioplasty  are  bound  to  abide  by  the  ceiling  prices  fixed  by  the  Government  for coronary stents and NPPA has not found any actionable violation after examining about 40 complaints.
- (b): Vide notification S.O. 412(E) dated 13 th February, 2017 and  S.O. 639(E) dated 12 th February,  2018,  all  hospitals/nursing  homes/clinics  utilizing  coronary  stents  have been instructed to mention specifically and separately the cost of the coronary stent, its category  like  BMS  or  DES,  brand  name,  name  of  the  manufacturer/importer/batch no./specifications  and  other  details,  if  any,  in  their  Estimate/Performa  invoice/Finalbilling, etc. to the patients  or their representative.

(c): NPPA  vide  its  notification  S.O.  639(E)  dated  12 th February  2018,  revised  the prices of cardiac stents. The revised prices are Rs. 27,890/- for DES (Drug eluting stent) and Rs. 7,660/- for BMS (Bare metal stent) while earlier prices were Rs. 30,180/- and Rs. 7,400/- respectively.

(d): Stakeholders'  consultations  with  the  coronary  stent  manufacturers,  industry associations, civil society groups, hospital and nursing home associations, and eminent cardiologists both from private and public sectors were held prior to revisiting the prices of coronary stents in order to make an assessment of the actual impact of price ceiling on cardiac healthcare, the status of market of indigenous manufacturing and imports, increased affordability and access to cardiac healthcare etc.

(e): Vide  Notification  No.  S.O.  639(E)  dated  12 th February,  2018,  all  healthcare institutions  which  are  performing  angioplasty  and  billing  the  patients  have  been instructed  to  mention  cost  of  cardiac  catheters,  balloon  catheter  and  guide  wire separately along with their respective brand name, if any, name of the company, batch number and specifications in  order to  bring  in  greater  transparency  in  the  billing  and monitoring of compliance with the Maximum Retail Prices (MRPs) by the NPPA under Para 20 of Drugs (Prices Control) Order, 2013 (DPCO, 2013).

(f) Government  has  alerted  all  the  State  Governments/UTs  and  State  Drugs Controllers  to  monitor  the  availability  of  stents  and  to  report  to  NPPA,  in  case  any adverse report on availability or pricing is noticed. NPPA has also requested aggrieved persons to send verifiable information / complaint to NPPA on helpline number of NPPA and  through  online  complaint  mechanism  -Pharma  Jan  Samadhan. Government  has also  directed  all  stent  manufacturers  /  importers  to  ensure  adequate  supplies  to hospitals  and  to  maintain  the  production  volume  as  existed  prior  to  price  fixation. Government  /  NPPA  held  discussions  with  the  stent  companies  which  in  turn  have ensured  availability  of  stents  at  notified  ceiling  price.  Further,  Government  has  also invoked para 3 of the DPCO, 2013 directing manufacturers to maintain the production level.

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