PLI Scheme for Pharmaceutical Industry

PLI Scheme for Pharmaceutical Industry – From 01.04.2020 – for 8 years
2020-21 Period of processing of application
2021-22 Optional gestation period
2022-23 onwards Incentive for 6 years

  • To enhance India’s manufacturing capabilities by increasing investment and production in the sector
  • To create global champions out of India to penetrate the global value chains
  • ₹15,000 Crores outlay is targeted under this scheme

Year

Category 1 & 2 Goods

Category 3 Goods

2022-23

10%

5%

2023-24

10%

5%

2024-25

10%

5%

2025-26

10%

5%

2026-27

8%

4%

2027-28

6%

3%

The incentive is given

  • If minimum incremental sale target is achieved, and 
  • Is subject to the maximum limit as per ceiling. 
  • These incentive rates are independent for every tax period. In case target is not met for any tax period, incentive would not be given only for that period.

Category 1

Category 2

Category 3

Bio-pharmaceuticals

Active pharmaceutical Ingredients / Key Starting Materials / Drug Intermediates

Repurposed Drugs

Complex generic drugs

 

Auto immune drugs, anti-cancer drugs, anti-diabetic drugs, anti- infective drugs, cardiovascular drugs, psychotropic drugs and anti- retroviral drugs

Patented drugs or drugs nearing patent expiry

 

In-vitro diagnostic devices

Cell based or gene therapy drugs

 

Other drugs as approved

Orphan drugs

 

Other drugs not manufactured in India

Special empty capsules like HPMC. Pullulan, enteric etc.

 

 

Complex excipients

 

 

Phyto-pharmaceuticals

 

 

Other drugs as approved

 

 

  • Global Manufacturing Revenue (FY 2019-20)

    Group

    Global Manufacturing Revenue of pharmaceutical goods (FY 2019-20)

    Maximum Incentive

    Maximum Applicants to be selected

    A

    >= 5000 Crore

    11,000 Crore

    11

    (Max 4 Foreign MNCs)

    B

    >= 500 Crore – < 5000 Crore

    ₹   2,250 Crore

    (Can be moved to Group A, if left unutilized)

    9

    (Max 3 Foreign MNCs)

    C

    < 500 Crore

    (Includes MSME Sector as well)

    ₹   1,750 Crore

    35

    (Min 20 MSMEs)

    (Min 5 in vitro diagnostic medical devices)

  • Revenues from any other source for instance R&D services, rental incomes, etc., shall be excluded for calculating the GMR.
  • Investment to be made on or after 01.04.2020.
    • ₹50 Crores by MSME and ₹250 Cr – ₹1000 Crores by others 
    • Date of tax invoice would be considered as date of investment 
    • Cost not included
      • Expenditure on guest house building, recreational facilities, office building, residential colonies and similar structures
      • Second hand/used/ refurbished plant, machinery, equipment, utilities or Research and Development equipment
      • Consumables and raw materials used for manufacturing
    • Cost included
      • Plant, machinery, equipment and associated utility
      • Research & Development
      • Transfer of Technology Agreements
      • Product registration
      • Expenditure on construction of Building where new P&M is installed
        • Associated infrastructure cost restricted to 20% of investment in P&M
  • Investment details are to be certified by statutory auditor or independent CA, as per details given in the scheme guidelines
  • Schedule of investment

    Year

    Group A

    Group B

    Group C

    Cumulative Investment (in Crores)

    Sales

    Cumulative Investment (in Crores)

    Sales

    Cumulative Investment (in Crores)

    Sales

     

    MSME

    2021-22

    200

     

    50

     

    10

    20%

     

    2022-23

    400

    > 50 Cr

    100

    > 10 Cr

    20

    40%

    > 1 Cr

    > 0.50 Cr (MSME)

    2023-24

    600

    7% high

    150

    7% high

    30

    60%

    7% high

    2024-25

    800

    7% high

    200

    7% high

    40

    80%

    7% high

    2025-26

    1000

    7% high

    250

    7% high

    50

    100%

    7% high

    2026-27

     

    7% high

     

    7% high

     

    7% high

    2027-28

     

    7% high

     

    7% high

     

    7% high

  • Submit application to Project Management Agency (PMA) through portal https://pli- pharma.udyamimitra.in    
  • Non-refundable application fee to be paid electronically as per details given below:

    Group A

    ₹ 1,00,000

    Group B

    ₹ 50,000

    Group C

    ₹ 25,000

    Group C – MSME

    ₹ 10,000

  • Application is to be submitted from 02nd June 2021 to 31st July 2021.
  • Undertaking in prescribed format is to be submitted.
  • PMA acknowledges and approves the application within a period of 90 days from last date.
  • Certificate of investment made in India as on 31.03.2021 is required from Statutory Auditor or independent CA, as specified in the scheme guidelines
  • Gross Manufacturing Investment (GMI) to be taken into consideration.

    Selection parameter

    Group A/B

    Group C

    Group C (MSME)

    Group A/B/C

    GMI (from 2010-11 to 2019-20)

    30%

    30%

    30%

    Number of ANDA/NDA of applicant/group company as on 01.04.2021

    30%

    30%

    30%

    R&D Expenditure of applicant / group company as a % of GMR from pharmaceutical drugs in 2017-18 to 2019-20

    40%

    GMR from pharmaceutical drugs in 2019-20

    40%

    Number of pharmaceutical plants in India owned by applicant / group company and approved

    50%

    Total committed investment

    50%

    GMR from in vitro diagnostic medical devices in FY 2019-20

     

     

     

    40%

  • In Group A, priority given to those applicants who commits higher amount of R&D Expenditure; in Group B to those who has higher GMR in 2019-20
  • Higher ‘Global Manufacturing Revenue’ is also to be considered in case of in-vitro diagnostic medical devices.
  • Selected applicant has to submit a bank guarantee.

Production Linked Incentive Scheme, 2021

CA Kashish Gupta, Managing Partner, Paksh Legal

[email protected]; 85108-06440

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