Lok Sabha Question No. 52 (STARRED), answered on 2017-12-19
Subject: Price of Medical Devices
Ministry: CHEMICALS AND FERTILIZERS
Asked by: RAMESH CHANDER KAUSHIK, RAMDAS CHANDRABHANJI TADAS

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

LOK SABHA STARRED QUESTION NO. *52

TO BE ANSWERED ON 19 th  December, 2017

## Price of Medical Devices

- *52. SHRI RAMESH CHANDER KAUSHIK: SHRI RAMDAS C. TADAS:

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

- (a)  whether  the  National  Pharmaceutical  Pricing  Authority  (NPPA)  has  carried  out  an assessment of mark-ups involved in the maximum retail prices of the following medical devices viz. Disposable Hypodermic  Syringes, Disposable Hypodermic  Needles, Disposable  Perfusion  Sets,  In  Vitro  Diagnostic  Devices  for  HIV,  HBs  Ag  and  HCV, Catheters, Intra Ocular Lenses, I V Cannulae, Bone Cements, Heart Valves, Scalp Vein Set,  Orthopaedic  implants,  internal  prosthetic  replacements,  Ligatures,  Sutures  and Staplers,  Intra  Uterine  Devices,  surgical  dressings,  umbilical  tapes,  blood  and  blood component bags and tubal rings; and
- (b) if so, the details thereof along with the assessment/report/study of the NPPA which contains the mark-ups of the above mentioned medical devices?

## ANSWER

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

- (a) & (b): A statement is laid on the Table of the House.

## Statement referred to in reply to Lok Sabha Starred Question No. *52 for answer on 19/12/2017 regarding Price of Medical Devices.

(a) & (b): Ministry of Health and Family Welfare has notified 23 medical devices as drugs under the Drugs and Cosmetics Act & Rules. Out of these, for 4 medical devices (Cardiac stents, drug eluting stents, condoms and intra uterine devices) which are in the National List of Essential Medicines (NLEM) and therefore covered under Schedule - I of  Drugs  (Prices  Control)  Order,  2013  (DPCO,  2013),  the  National  Pharmaceutical Pricing Authority (NPPA) has fixed a price cap. The remaining 19 medical devices are non-scheduled  formulations.  The  NPPA  is  mandated  to  monitor  the  Maximum  Retail Price  (MRP)  of  all  these  non-scheduled  formulations  including  medical  devices viz . Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion Sets, In Vitro Diagnostic Devices for HIV, HBs Ag and HCV, Catheters, Intra Ocular Lenses, I V  Cannulae,  Bone  Cements,  Heart  Valves, Scalp Vein Set, Orthopaedic implants, internal prosthetic replacements, Ligatures, Sutures and Staplers,  Intra  Uterine  Devices,  surgical  dressings,  umbilical  tapes,  blood  and  blood component  bags  and  tubal  rings. NPPA  is  also mandated  to  ensure  that no manufacturer increases the  maximum  retail price  of  a  drug  more  than  ten  percent  of maximum retail price during preceding twelve months and where the increase is beyond ten percent of maximum retail price, it shall reduce the same to the level of ten percent of maximum retail price for next twelve months. In case of knee implants, it was found that there was a mark up upto 449%. The Government has fixed and notified the ceiling prices  of  orthopedic  knee  implants  for  knee  replacement  system  in  exercise  of  the powers under paragraph 19 of DPCO, 2013. NPPA also studies the mark ups involved in  the  maximum retail prices of these devices from time to time and their findings are uploaded in public domain at NPPA's website i.e. www.nppaindia.nic.in.

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