Lok Sabha Question No. 381 (STARRED), answered on 2016-08-12
Subject: Coronary Stents under NLEMs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: BIDYUT BARAN MAHATO, ANANDRAO  ADSUL

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO.381 TO BE ANSWERED ON THE 12 TH AUGUST, 2016 CORONARY STENTS UNDE R NLEMS

## *381. SHRI BIDYUT BARAN MAHATO:

## SHRI ANANDRAO ADSUL:

Will  the  Minister  of HEALTH  AND  FAMILY  WELFARE be  pleased  to state:

- (a)  whether  the  Government  has  accepted  and  implemented  the  recommendati made by the sub- committee of  expert  cardiologists  for inclusion of coronary s ents under the National List of Essential Medicines (NLEMs) and if so, the detail along with the major recommendations made by the sub - committee;
- (b) whether the medical device industry has raised concern about the said mo so, the detai ls thereof along with the response of the Government thereto;
- (c) whether the inclusion of coronary stents under NLEMs would reduce the the overall treatment procedure to the heart patients; and
- (d)  if  so,  the  details  thereof  along  with  the  oth er  steps  taken/being  taken  by  the Government to reduce the overall cost of procedures in the Government as private hospitals for heart patients?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI JAGAT PRAKASH NADDA )

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

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 381* FOR 12 TH AUGUST, 2016

(a) The Ministry of Health and Family Welfare constituted a Sub - Committee of the Core  Committee  that  reviewed  the National  List  of  Essential  Medicines  (NLEM), 2011  under  the  Chairmanship  of  Professor  YK  Gupta,  Professor  and  He Department of Pharmacology, AIIMS, New Delhi on 15.10.2015 to examine issu relating  to  essentiality  of  coronary  stents.  After  holding  wide consultations  with experts  and  stakeholders  including  manufacturers  and  industry  associatio considering all relevant aspects,  including economic  issues, accessibi affordability, the Sub - Committee, in its report, inter alia, recommended that coronary stents be included in NLEM and may be considered under following categories:

- (i) Bare Metal Stents (BMS)

(ii) Drug Eluting Stents (DES)

The  Sub- Committee  further  recommended  that  various  incremental  innovations technology  of  the  coronary  stents  may  be considered  for  sub  categorization  if acceptable evidences are produced in terms of safety and benefits.

The Government, after examination of the report, has accepted the recommend of the Sub - Committee and notified inclusion of stents in the NLEM on 1 9.7.2016.

(b) Some  representations  have  been  received  from  the  Medical  Devices  indu associations after inclusion of stents in the NLEM. The decision of the Go has been welcomed by some associations stating that it will enhance accessib nd affordability  of  medical  devices.  A  few  other  associations  have  informed decision will stifle innovation and impede introduction of new stents in the

(c) & (d)Inclusion of coronary stents in NLEM by itself does not reduce the f overall  treatment  procedure.  However,  once  the  National  Pharmaceutical  P Authority  (NPPA)  regulates  prices  of  stents  under  Drugs  (Price  Control) (DPCO), 2013, the prices are expected to go down.

The Ministry of Health and Family Welfare has further started AMRIT (Affordable Medicines and Reasonable Implants for Treatment) stores where essential lif medicines and implants including stents are being provided at a substantial vis - à- vis the Maximum Retail Price.

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