Lok Sabha Question No. 2331 (UNSTARRED), answered on 2021-03-09
Subject: Affordable Medical Devices
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Rajendra Dhedya  Gavit, Sudhakar Tukaram Shrangre, Sudheer Gupta, Shrirang Appa Barne, Ranjeetsingh Naik Nimbalkar, Bidyut Baran Mahato, Sanjay Sadashivrao Mandlik, Shivkumar Chanabasappa Udasi, Chandra Sekhar Sahu

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

LOK SABHA UNSTARRED QUESTION No. 2331 TO BE ANSWERED ON THE 09 th  MARCH, 2021

## Affordable Medical Devices

2331.   SHRI RAJENDRA DHEDYA GAVIT:

SHRI SUDHAKAR TUKARAM SHRANGARE:

SHRI SUDHEER GUPTA:

SHRI SHRIRANG APPA BARNE:

SHRI RANJEETSINGH HINDURAO NAIK NIMBALKAR:

SHRI BIDYUT BARAN MAHATO:

SHRI SANJAY SADASHIVRAO MANDLIK:

SHRI SHIVAKUMAR C. UDASI:

SHRI CHANDRA SEKHAR SAHU:

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

- (a) whether the Government has been encouraging the domestic manufacturing of affordable medical devices, bulk drugs and pharmaceuticals under its 'Make in India' initiative and if so, the details thereof;
- (b) the extent to which such policies and schemes has boosted India's affordable generics and medical devices sector;
- (c) the details of the contribution of the country's export of affordable generics and medical devices;
- (d) whether Indian pharma market is expected to grow to US$ 130 billion by 2030;
- (e) if so, the details of the steps taken by the Government to achieve the growth targets of the country; and
- (f) the details of employment opportunities likely to be increased in this sector by 2030?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI D.V. SADANANADA GOWDA)

(a) & (b): Yes Sir, the Government is encouraging the domestic manufacturing of affordable medical  devices,  bulk  drugs  and  pharmaceuticals  under  its  'Make  in  India'  initiative.  The Department  of  Pharmaceuticals  has  recently  launched  following  two  schemes  for  Medical Devices Sector:

- i. Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices: The Scheme has been approved by the Government of India on 20th March, 2020. The revised guidelines for implementation of the scheme has been issued on 29.10.2020. The Scheme is applicable only to the Greenfield projects and intends to boost domestic manufacturing and attract large investments in the Medical Devices
2. Sector. Under the Scheme, financial incentive will be given to selected companies at the  rate  of  5%  of  incremental  sales  of  medical  devices  manufactured  in  India  and covered under the Target segments of the scheme, for a period of five (5) years. The tenure of the scheme is from FY 2020-21 to FY 2027-28. The total financial outlay of the Scheme is Rs. 3,420 crore. The scheme is under implementation.
- ii. Promotion  of  Medical  Device  Parks: Recognizing  the  need  for  higher  levels  of investments for the creation of testing and laboratory facilities, this Scheme has been approved by the Government of India on 20th March 2020. The parks will provide common  testing and laboratory facilities / centre at one place reducing the manufacturing  cost  significantly  and  will  help  in  creating  a  robust  ecosystem  for medical device manufacturing in the country. The total financial outlay of the scheme is Rs. 400 crore. The tenure of the scheme is from FY 2020-2021 to FY 2024-2025. Financial assistance to a selected Medical Device Park would be 70% of the project cost of common infrastructure facilities. In case of North Eastern States and Hilly States (Himachal Pradesh, Uttarakhand, Union Territory of Jammu & Kashmir and Union Territory of Ladakh) financial assistance would be 90% of the project cost. Maximum assistance under the scheme for one Medical Device Park would be limited to Rs. 100 crore. The scheme is under implementation.

Also, the Department of Pharmaceuticals has recently launched following three schemes for promoting  domestic  manufacturing  of  critical  KSMs/Drug  Intermediates  and  APIs  by attracting  large  investments  in  the  sector  to  ensure  their  sustainable  domestic  supply  and thereby  reduce  India's  import  dependence  on  other  countries  for  critical  KSMs/Drug Intermediates and APIs:

- i. Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing  of  critical  Key  Starting  Materials  (KSMs)/  Drug  Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) In India: Under the scheme, financial incentive is given for manufacturing of 41 eligible products under the four Target Segments viz.:
- a. Fermentation based KSMs/Drug Intermediates.
- b. Fermentation based niche KSMs/Drug Intermediates /APIs.
- c. Key Chemical Synthesis based KSMs/Drug Intermediates.
- d. Other Chemical Synthesis based KSMs/Drug Intermediates/APIs.

Incentives for incremental sales will be given to selected participants for a period of 6 years. The total outlay of the scheme is Rs. 6,940 crore.

- ii. Scheme for Promotion of Bulk Drug Parks: To provide grant-in-aid to 3 Bulk Drug Parks for creation of Common Infrastructure Facilities (CIF) with a maximum limit of Rs.1000 crore per park or 70% of the project cost of CIF, whichever is less. In case of North Eastern States and Hilly States (Himachal Pradesh, Uttarakhand, Union Territory of Jammu & Kashmir and Union Territory of Ladakh) financial assistance would be 90% of the project cost. The total size of the Scheme is Rs. 3000 crore and the tenure of the Scheme will be five years (2020-21 to 2024-25).
- iii. Production Linked Incentive Scheme for Pharmaceuticals: The Union Cabinet in its  meeting  on  24.02.2021  approved  Production Linked  Incentive scheme  for Pharmaceuticals with the objective to enhance India's manufacturing capabilities by increasing  investment  and  production  in  the  sector  and  contributing  to  product

diversification  to  high  value  goods  in  the  pharmaceutical  sector.  One  of  the  further objectives  of  the  scheme  is  to  create  global  champions  out  of  India  who  have  the potential to grow in size and scale using cutting edge technology and thereby penetrate the  global  value  chains.  The  outlay  of  the  scheme  is  Rs  15,000  crore  and  three categories of pharmaceutical goods will be incentivized under the scheme based on their incremental sales.  The tenure of the scheme will be from FY 2020-2021 to 202829. The Scheme has been notified on 03.03.2021 in the Gazette of India.

## (c): The details of generics exports are as follows:

| India's Generic Pharma exports US $ Million   | India's Generic Pharma exports US $ Million   | India's Generic Pharma exports US $ Million   | India's Generic Pharma exports US $ Million   | India's Generic Pharma exports US $ Million   |
|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Category                                      | 2017-18                                       | 2018-19                                       | 2019-20                                       | 2020-21 (April-December)                      |
| Drug Formulations (Generics)                  | 12900.28                                      | 14368.65                                      | 15811.24                                      | 13966.85                                      |

| India's Medical Device exports US $ Million   | India's Medical Device exports US $ Million   | India's Medical Device exports US $ Million   | India's Medical Device exports US $ Million   | India's Medical Device exports US $ Million   |
|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| Category                                      | 2017-18                                       | 2018-19                                       | 2019-20                                       | 2020-21 (April-November)                      |
| Medical Devices                               | 1868.05                                       | 2138.14                                       | 2292.87                                       | 1549.89                                       |

- (d): As per economic survey 2020-21, the Pharma Sector is expected to grow to about US $ 120-130 billion by 2030.
- (e): The Department of Pharmaceuticals has launched following three schemes to achieve the growth targets of the country:
- i. Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of  critical  Key  Starting  Materials  (KSMs)/  Drug  Intermediates  (DIs)  and  Active Pharmaceutical Ingredients (APIs) In India
- ii. Promotion of Bulk Drug Parks
- iii. Production Linked Incentive Scheme for Pharmaceuticals
- (f): Approximately, 2 lakh jobs, direct and indirect, are likely to be created through industry promotion schemes of the Department by 2030.

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