Lok Sabha Question No. 749 (UNSTARRED), answered on 2025-02-07
Subject: Refurbished Medical Devices
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Manickam Tagore B, Shri Vijayakumar Alias Vijay Vasanth

## 749.

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

LOK SABHA UNSTARRED QUESTION NO. 749 TO BE ANSWERED ON 07 th   FEBRUARY, 2025

## Refurbished Medical Devices

## Shri Vijayakumar Alias Vijay Vasanth: Shri Manickam Tagore B:

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

(a)  whether  the  Government  has  directed  the  Customs  Department  to  halt  the  import  of refurbished medical devices, if so, the details thereof and the reasons for not taking such a move earlier, given the known risks associated with these devices;

(b) the specific steps taken by the Government to ensure the availability of affordable and highquality  medical  devices,  especially  for  underserved  regions,  in  the  absence  of  refurbished imports;

(c) the detailed plan of the Government for providing support to local manufacturers to meet the growing demand for medical devices in the country;

(d) the measures that are in place to ensure that this does not lead to an increase in the prices of medical devices, thereby burdening patients and healthcare providers; and

(e)  whether  adequate  checks  are  in  place  to  monitor  the  quality  and  safety  of  domestically produced medical devices, if so, the details thereof and the manner in which the Government plans to maintain competitive pricing?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF  CHEMICALS AND FERTILIZERS

(SMT. ANUPRIYA PATEL)

(a): The Central Drugs Standard Control Organisation (CDSCO) has informed that all medical devices are regulated by the Medical Devices Rules, 2017. As per Chapter V of the said rules, medical devices are imported in the country against a valid import licence issued by CDSCO. Under the said rules, there is no specific provision for regulation of refurbished medical devices. Any importer possessing a valid licence is permitted to import a medical device under the Drugs and Cosmetics Act, 1940.

(b) to (d): With a view to ensure the availability of affordable and high-quality medical devices, especially  for underserved regions, Government has included four medical devices, namely Bare Metal Stents, Drug Eluting Stents including metallic ones and Bioresorbable Vascular

Scaffold / Biodegradable stents, Condoms and Intra Uterine Devices in Schedule-I of the Drugs (Prices  Control)  Order,  2013  (DPCO,  2013)  and  pursuant  to  the  same,  the  National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals has fixed ceiling prices for the said medical devices. In addition to these, NPPA, vide its  notification dated 16.8.2017 has fixed the ceiling prices for Orthopedic Knee Implants for knee replacement system.  Presently,  the  ceiling  prices  of  the  Orthopedic  Knee  Implants  are  notified vide notification no. S.O. 3869(E), dated 10.9.2024.

Further,  the  Department  of  Health  and  Family  Welfare, vide notification no.  S.O. 648(E), dated 11.2.2020 has notified all medical devices intended for use in human beings or animals  as  'drugs'  under  the  Drugs  and  Cosmetics  Act,  1940,  with  effect  from  1.4.2020. Pursuant to the same, NPPA, vide notification no. S.O. 1232(E), dated 31.3.2020 has notified that all medical devices shall be governed under the provisions of DPCO, 2013, with effect from 1.4.2020.

Moreover, NPPA monitors the maximum retail prices of all non-scheduled medical devices and ensures that no manufacturer increases the maximum retail price of any medical device by more than 10% of the maximum retail prices during the preceding 12 months.

The Government has also taken several measures to encourage domestic manufacturing of high-end medical devices, with a view to reduce imports dependence and boost domestic manufacturing. The programmatic interventions for the same are as follows:

- (i) Production Linked Incentive (PLI) scheme for promoting domestic manufacturing of Medical Devices: This scheme has a financial outlay of ₹3,420 crore and a tenure from the  financial  year  (FY)  2020-2021  to  FY  2026-27.  Under  the  scheme,  selected companies are eligible for financial incentive at the rate of 5% of incremental sales of medical  devices  manufactured  in  India  under  the  four  target  segments  of  (1) radiotherapy, (2) imaging devices, (3) anaesthesia, cardio-respiratory and critical care, (4)  implants,  for  a  period  of  five  years.  19  Greenfield  projects  have  so  far  been commissioned and production has started for 46 products,  which include high-end medical devices such as linear accelerator, MRI machines, CT scans, mammograms, C-arms  and  ultrasound  machines  that  were  being  imported.  Applicants  under  the scheme have made cumulative sales ₹9,117.07 crore, including export sales worth ₹4,398.34 crore, till December 2024.
- (ii) Scheme for Promotion of Medical Devices Parks: The scheme aims to provide easy access to world-class, common infrastructure facilities to medical device units located in parks. It has a financial outlay of ₹400 crore. Approvals for creation of common infrastructure facilities in the proposed medical device parks have been conveyed in respect of proposals received from the State Governments of Uttar Pradesh, Tamil Nadu, Madhya Pradesh and Himachal Pradesh.
- (iii) Scheme for Strengthening Medical Device Industry: This scheme, with a financial outlay of ₹500 crore, has been launched on 8.11.2024, with a view to provide support in critical areas of the medical device industry, under the following five sub-schemes:
- (1) Common Facilities for Medical Devices Clusters;
- (2) Marginal Investment Scheme for Reducing Import Dependence;
- (3) Capacity Building and Skill Development for Medical Devices;
- (4) Medical Device Clinical Studies Support Scheme; and
- (5) Medical Device Promotion Scheme.

(e): The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and  Family  Welfare  has  informed  that  import  of  all  classes  of  medical  devices  as  well  as manufacture of Class C and D medical devices is regulated by CDSCO, while manufacture of Class A and B medical devices is regulated by the State Licensing Authority (SLA) appointed by  the  State  Governments  concerned.  However,  the  sale  and  distribution  of  all  classes  of medical  devices  are  regulated  by  the  SLAs  concerned.  For  obtaining  licence  for  import  or manufacture of any medical device from CDSCO or SLA, the applicant is required to submit the  details  of  design,  specification,  non-clinical  as  well  as  clinical  data  of  safety  and performance of the devices including regulatory status in other countries, etc. In case of medical devices, the quality, safety and performance data are evaluated by CDSCO in consultation with the Subject Expert Committee in the relevant therapeutic areas.

******