Lok Sabha Question No. 4975 (UNSTARRED), answered on 2023-03-31
Subject: PLI Scheme for Pharmaceutical Sector
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Su Thirunavukkarasar

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

LOK SABHA UNSTARRED QUESTION No. 4975

TO BE ANSWERED ON THE 31 st  MARCH, 2023

## PLI Scheme for Pharmaceutical Sector

## 4975. SHRI THIRUNAVUKKARASAR SU:

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

- (a) the number of projects commissioned for various products so far under the Product Linked Incentive (PLI) scheme;
- (b)  whether  the  Government  has  taken  steps  to  boost  domestic  production  of  high  value formulations, critical APIs and High-End Medical Devices under the PLI Scheme;
- (c) if so, the details thereof and the extent to which it would promote Aatmanirbharta; and (d) if not, the reasons therefor?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI BHAGWANTH KHUBA)

- (a)  to  (d):  The  Government  of  India  has  taken  several  measures  to  encourage  domestic manufacturing of Pharmaceutical drugs including bulk drugs and high end medical devices to reduce import dependence  and to boost domestic manufacturing.  The  Programmatic interventions to support domestic manufacturing of APIs are as follows;
- i. The 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 , with a financial outlay of Rs. 6,940  crores  and  the  tenure  from  FY  2020-2021  to  FY  2029-30,  provides  for  the financial  incentive  for  41  identified  products.  A  total  of  51  applications  have  been selected under the scheme. Out of these, 22 projects have already been commissioned with the installed capacity of 34,255 MT
- ii. PLI Scheme for Pharmaceuticals ,  with  a  financial  outlay  Rs.  15,000  crores  and  the tenure  from  FY  2020-  2021  to  FY  2028-29,  provides  for  financial  incentive  to  55 selected applicants for manufacturing of identified products under three categories for a period of six years.  This scheme also covers the APIs, other than those covered under the  PLI  scheme  under  Bulk  Drugs  as  mentioned  at  Point  (i).   Projects  have  been commissioned  in  261  manufacturing  locations,  out  of  total  309  manufacturing locations.
- iii. PLI  Scheme  for  Promoting  Domestic  Manufacturing  of  Medical  Devices with  total financial  outlay  of  Rs.  3,420  crore  and  tenure  from  FY  2020-2021  to  FY  2027-28, provides  incentive  to  selected  companies  at  the  rate  of  5%  on  incremental  sales  of medical devices manufactured in India and covered under the four Target segments of
- the scheme, for a period of five (5) years. Under the scheme, 26 applications have been approved  and  14  projects  have  been  commissioned.  Under  the  scheme,  domestic manufacturing of high-end medical devices has started which  include Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C- Arm, MRI Coils, high end X-ray tubes, etc
- iv. Under the Scheme for Promotion of Bulk Drug Parks , proposals of Andhra Pradesh, Gujarat and Himachal Pradesh have been approved for financial support to facilitate setting up of three (3) Bulk Drug Parks in the country. The total financial outlay of the scheme is Rs. 3000 crore and the tenure of the Scheme is from 2020-21 to 2024-25. The financial assistance by the centre is subject to a maximum limit of Rs.1000 Crore per park or 70% of the project cost of CIF (90% in case of North Eastern States and Hilly States), whichever is less.
- v. Under the major non-schematic intervention, in order to attract investments in Pharma sector including for APIs, the Government has allowed 100% FDI in pharma sector for greenfield projects under automatic route. For the brownfield projects, upto 74%, FDI investments  are  allowed  under  automatic  route  and  beyond  74%  to  100%,  FDI investments are allowed under government approval route. Similarly, the Government has allowed 100% FDI in medical devices sector under automatic route.

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