Lok Sabha Question No. 1146 (UNSTARRED), answered on 2019-06-28
Subject: Medical Equipments Market
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Sanjay Haribhau Jadhav, Krupal Balaji Tumane

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

LOK SABHA UNSTARRED QUESTION NO.1146 TO BE ANSWERED ON 28 TH JUNE, 2019

## MEDICAL EQUIPMENTS M ARKET

## 1146. SHRI SANJAY HARIBHAU JADHAV:

## SHRI KRUPAL BALAJI TUMANE:

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

- (a)  the  size  of  medical  equipments  market  in  India  and  the  quantum  of  medical  equipm imported during each of the last three years and till date;
- (b) w hether the Government is aware that medical equipments like stents, catheters and implants are being sold at higher rates to patients in the country and if so, the details the reasons therefor;
- (c) whether the Government has asked the ma nufacturers of such medical equipments to submit the complete details of production and rate fixation of their products and if so, the deta
- (d) the measures being taken by the Government to monitor and regularize the prices of medi equipments and to protect the customers being overcharged by hospitals/companies; and
- (e)  the  steps  being  taken  by  the  Government  to  promote  domestic  manufacturing  of medical equipments at affordable price?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

(SHRI ASHWINI KUMAR CHOUBEY)

- (a): Central Drugs Standard Control Organisation (CDSCO) under Ministry of Health and Family Welfare regulates the quality, safety and performance of notified category of m devices under the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under.

As per the data received from port offices of CDSCO, value of import of medical dev during last 3 years is below:

| Year                  |   2016- 17 |   2017- 18 |   2018- 19 |   2019-till 24.06.19 |
|-----------------------|------------|------------|------------|----------------------|
| Value in Crore Rupees |    4372.61 |    3615.13 |    5210.26 |              2611.57 |

(b):National  Pharmaceuticals  Pricing  Authority  (NPPA)  under  the  Ministry  of  Chemicals Fertilizers had fixed ceiling prices of Bare Metal and Drug Eluting Cardiac Stents (sc medical device) in February 2017. NPPA had also fixed ceiling prices of Orthop edic Implants for Knee Replacement System (non - scheduled medical device) in August 2017 in extraordinary circumstances in the larger public interest.

NPPA is monitoring implementation of ceiling pries of Cardiac Stents and Knee Impla across the country. In this regard, no complaint of overcharging has been received so far regard Catheters (non - scheduled medical device), NPPA has not fixed its ceiling price. Howeve NPPA  monitors  price  movement  of  Catheters  so  that  no  manufacturer  can  incre ase  the  price more that 10% in preceding twelve months.

(c): NPPA  collected  costing  data  from  importers/manufactures  of  Cardiac  Stents  and  Kne Implants at the time of fixing their ceiling prices. With regard to Catheters, NPPA has MRP details from importers/manufactures of Catheters to monitor the price increase.

(d): The Government controls price of only medical devices declared as essential drugs. O 23  Medical  Devices  notified  as  'Drugs'  under  Drugs  &  Cosmetics  Act  only  three  devices namely  'Condom',  'IUD  containing  copper'  &  'coronary  Stents'  have  been  included  in  the National List of Essential Medicines - 2015 (NLEM - 2015) and therefore included in Schedule -I of Drugs (Price Control) Order, 2013 (DPCO, 2013) and are under price control.

Knee Implant, though not included in Schedule I of DPCO, has also been given a price under Paragraph of 19 of DPCO. No price cap has been fixed on rest of the notified devi they come under non - scheduled category. However, manufactures are not allowed to increase the price  of  non - scheduled  drugs  more  than  10%  per  annum  under  DPCO.  NPPA  continuously monitors market prices of all drugs and notified medical devices.

(e): Realizing the needs of medical devices sector, the Government has op erationalized a sub -scheme namely development of Common Facility Centre for Medical Devices (DCFC - MD). It aims to provide financial assistance to upcoming medical device parks for creation of Co Facility  Centre  (CFC).  This  move  is  expected  to  bring  dow n  the  manufacturing  cost  of indigenous medical devices, thus making them competitive and boost 'Make in India'. Further, pursuant  to  the  Public  Procurement  (Preference  to  Make  in  India)  Order,  2017, Pharmaceuticals has issued guidelines for implementat ion of this order on 18.05.2018. Further D/o Pharmaceuticals vide Office Memorandum dated 16.10.2018 has amended the guidelines clarifying that USFDA/CE certifications etc. shall not be mandatory for those medical d for which Bureau of India Standard s (BIS) standards exist. This move is also expected to boos manufacturing of indigenous medical devices.

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