Lok Sabha Question No. 204 (STARRED), answered on 2019-12-03
Subject: Affordable Medical Devices
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Manoj Kishorbhai Kotak

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

LOK SABHA STARRED QUESTION No. 204

TO BE ANSWERED ON THE 3 rd  December, 2019

## Affordable Medical Devices

## *204. SHRI MANOJ KOTAK:

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

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

## ANSWER

MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS

(SHRI D. V. SADANANDA GOWDA)

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

## STATEMENT  REFFERED  TO  IN  REPLY  TO  PARTS  (a)  TO  (e)  OF  LOK  SABHA STARRED QUESTION NO. 204 FOR REPLY ON 03.12.2019

(a), (b) & (c): Out of 24 notified/regulated medical devices listed as drugs by Ministry of Health and Family Welfare, 4 devices namely (i) Cardiac Stents, (ii) Drug Eluting Stents (iii)  Condoms and (iv) Intra Uterine Devices have been included in the National List of Essential  Medicines  and  are  under  price  control  in  Schedule-I  of  the  Drugs  Prices Control Order, 2013 and ceiling prices have been fixed.

Price  capping of Coronary Stents by the National Pharmaceutical Pricing Authority in 2017  and  2018  resulted  in  price  reduction  upto  85%.  The  price  fixation  of  coronary stents has resulted in the annual notional saving of Rs.4,547 crores to the public.

Under  para  19  of  DPCO,  2013,  Government  fixed  the  ceiling  prices  of  Orthopaedic Knee Implants for knee replacement vide notification dated 16 th August, 2017.  This has resulted in average price reduction of various type of Knee implant upto 69% resulting in annual notional savings of Rs.1,500 crore to the consumer.

The  MRPs  of  remaining  20  medical  devices,  being  non-scheduled  category,  are monitored by the National Pharmaceutical Pricing Authority 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.

NPPA  so  far  has  issued  27  demand  notices  to  23  Medical  Device  companies  for violation  of  para  20  of  DPCO,2013  for  a  total  amount  of  Rs.185  crore  (overcharge amount and interest) of which, an amount of Rs.25.50 crore has been recovered from the companies till 15.11.2019.

(d)  &  (e):  With  the  objective  to  ensure  drug  security  in  the  country  by  increasing  the efficiency and competitiveness of domestic pharmaceutical industry the Department of Pharmaceuticals has prepared an umbrella scheme for Development of Pharmaceuticals Industry with the following sub-schemes: (a) Assistance to Bulk Drug Industry  for  Common  Facility  Centre;  (b)  Assistance  to  Medical  Device  Industry  for Common  Facility  Centre;  (c)  Pharmaceuticals  Technology  Upgradation  Assistance Scheme  (PTUAS);  (d)  Assistance  to  Pharmaceutical  Industry  for  Common  Facilities; and (e) Pharmaceutical Promotion Development Scheme (PPDS). The said scheme is a Central Sector Scheme with a total financial outlay of Rs. 480 Crore.

Under  the  sub-scheme  'Assistance  to  Medical  Device  Industry  for  Common  Facility Centre', financial assistance would be provided for creation of common facilities in any upcoming  Medical  Device  Park  promoted  by  State  Governments/State  Corporations. The Scheme would be implemented through a one-time grant-in-aid to be released to a

State  Implementing  Agency  (SIA)  set  up  for  the  purpose.  Some  of  the  indicative activities  under  the  Common  facilities  include  Component  Testing  Centre,  Electromagnetic interference laboratory, Biomaterial / Biocompatibility testing centre, Medical grade low vacuum  moulding, Cabinet moulding injection moulding centers,  2D designing  and  printing  for  medical  grade  products,  Sterilization  and  Toxicity  testing centre, Radiation testing centre, etc. The maximum limit for the grant-in-aid under this category  would  be  Rs.  25  Crore  per  Medical  Device  Park  Common  Facility  Center (CFC)  or  70%  of  the  project  cost  of  CFC  whichever  is  less.  So  far,  the  following proposals have been received:

- i. Andhra Pradesh Medtech Zone Ltd. (AMTZ) for creation of CFC for Superconducting Magnetic Coils Testing & Research. AMTZ is an enterprise under the Government of Andhra Pradesh located at Visakhapatnam.
- ii. Government  of  Telangana for Biomaterials  and  biocompatibility  testing  lab, Electrical  safety  and  reliability  testing  lab  and  Radiation  testing  lab. Govt.  of Telanagana is establishing a medical device park near Hyderabad at Sultanpur in Sangareddy  district.  The  project  is  currently  being  executed  by  the  Telangana State Industrial Infrastructure Corporation (TSIIC) which is the State Implementing Agency and has title over the land under construction.
- iii. HLL Medipark Ltd. (HML) for Rapid Prototyping Facility, State of Art Calibration Centre,  Skill  Development  Centre  and  Common  Logistics  Centre. HML  is developing a medical device park spread over 330 Acre in Kanchipuram district in Tamilnadu.
- iv. Kerala  State  Industrial  Development  Corporation  (KSIDC)  in  association with Sree Chitra Tirunal Institute of Medical Sciences and Technology for Prototyping-Pilot  Manufacturing  &  Incubation  Centre,  Medical Device  Testing  and  Evaluation  Centre,  R&D  Resource  Centre,  Knowledge Resource Centre & Large Animal Breeding Centre. The project will be based in Thiruvananthapuram, Kerala.

In-principle  approval to  all  four  proposals  has  been  accorded  by  the  Scheme Steering Committee (SSC) in 2019.

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