Lok Sabha Question No. 1194 (UNSTARRED), answered on 2021-07-27
Subject: Affordable Medical Devices
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Raghu Ramakrishna Raju Kanumuru, Manoj Kishorbhai Kotak

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

LOK SABHA UNSTARRED QUESTION NO.1194 TO BE ANSWERED ON 27 th  July, 2021

## Affordable Medical Devices

## 1194. SHRI KANUMURU RAGHU RAMA KRISHNA RAJU: SHRI MANOJ KOTAK:

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

- (a) whether the Government has any proposal to provide affordable medical devices/equipments and surgical items in the country, if so, the details thereof;
- (b) the details of the steps taken by the Government to make surgical items affordable in the country;
- (c)  whether the Department of Pharmaceuticals has launched any Umbrella Scheme in this regard; and
- (d) if so, the details thereof and the progress regarding the implementation of the said Scheme?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI MANSUKH MANDAVIYA)

(a)  and  (b)  :The  Government  has  taken  various  measures  to  provide  affordable  medical devices/equipments and surgical items to the citizens in the country.

With an objective of making quality generic medicines, surgicals & consumables available at affordable  prices  to  all  the  citizens,  especially  to  the  poor  and  the  deprived  ones,  Pradhan Mantri  Bhartiya  Janaushadhi  Pariyojana  (PMBJP)  was  launched  by  the  Department  of Pharmaceuticals.  Under  the  scheme,  more  than  7,900  dedicated  outlets  known  as  Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJK) have been opened in all the districts of the country.  The  product  basket  of  PMBJP  presently  comprises  of  1,451  medicines  and  204 surgicals & consumables.

Further,  the  National  Pharmaceutical  Pricing  Authority  (NPPA)  under  the  Department  of Pharmaceuticals has fixed the ceiling prices of the Coronary Stents and Knee Implants under Para  19  of  the  DPCO,  2013  vide  Notifications  dated  13 th Feb  2017  and  16 th August  2017 respectively in the larger public interest.  Further, NPPA has  extended ceiling price of four medical  devices,  which  have  been  included  in  the  National  List  of  Essential  Medicines (NLEM) and in Schedule-I of the  Drugs  (Prices  Control)  Order,  2013(DPCO,  2013),  viz., Cardiac Stents, Drug Eluting Stents, Condoms and Intra Uterine Devices (Cu-T).

Recently, NPPA invoked Paragraph 19 of the DPCO, 2013 to regulate the price of Oxygen Concentrators vide  Notification dated 03.06.2021, and prices of (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v) Glucometer under 'Trade Margin Rationalisation' Approach vide Notification dated 13.07.2021, in view of the extraordinary circumstances arising due to COVID pandemic and with the aim of making these medical devices affordable during the evolving pandemic.

NPPA  also  monitors  prices  of  28  notified  medical  devices  under  compulsory  licensing framework under Para 20 of the DPCO, 2013 to ensure their MRP is not increased more than 10% in preceding twelve months.

(c) & (d): As part of the Umbrella Scheme on 'Development of Pharmaceutical Industry', there  is  a  sub-scheme,  viz.,  'Production  Linked  Incentive  Scheme  for  Promoting  Domestic Manufacturing  of  Medical  Devices'  with  an  outlay  of  Rs.  3,420  cr.  to  boost  domestic manufacturing and attract large investments in the Medical Devices Sector. Under the Scheme, financial incentive is given to the selected companies at the rate of 5% on incremental sales of medical devices manufactured. Under the Scheme, 13 applications have been approved with a total  Committed  Investment  of  Rs.798.93  crore.  Another  sub-scheme  under  the  Umbrella Scheme for 'Promotion of Medical Device Parks' with an outlay of Rs. 400 cr. provides support for creation of common infrastructure facilities to provide easy access to standard testing and infrastructure  facilities  through  creation  of  world  class  common  infrastructure  facilities  for medical devices.

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