Lok Sabha Question No. 2983 (UNSTARRED), answered on 2023-03-17
Subject: PLIs for Pharmaceutical Sector
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Thirumaa Valavan Thol

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

LOK SABHA UNSTARRED QUESTION No. 2983 TO BE ANSWERED ON THE 17 TH  MARCH, 2023

## PLIs for Pharmaceutical Sector

## 2983. SHRI THIRUMAAVALAVAN THOL:

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

- (a) whether the Productions Linked Incentive Scheme (PLIS) for Pharmaceutical sector was announced by the Government and if so, the details thereof;
- (b) whether the Government has the details of the pharmaceutical companies which have been benefitted by the PLIS and if so, the details thereof;
- (c) the details of Critical Key Starting Materials/ Drug intermediates/Active Pharmaceutical Ingredients  the  production  of  which  have  been  increased  or/and  expected  to  be  increased further; and
- (d) the details of amount of funds disbursed to pharmaceutical companies by way of incentive, since the launch of PLIS?

## 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 Medical Devices to reduce import  dependence  and  to  establish a dominant  position  in the global  market.  The Programmatic interventions to support Pharma Industries as on date are as follows;
- i. Under  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,  the  financial  incentive  is planned to be provided 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.    As  per  the  information  submitted  by  the applicants on the sales for the period from April 2022 to December 2022, a total sale of 3972.55 MT of 12 Bulk Drugs covered under the scheme, with a value of Rs.389.89 Cr has been reported. The details of Critical KSMs / DIs /APIs Ingredients approved under the scheme, whose production is expected to increase, are given and sales details of 12 bulk drugs are given at Annexure-1 .
- 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).

- 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. 26 applicants have been approved and fourteen projects have been commissioned so far .

FY  2022-23  is  the  first  year  of  production  for  all  the  three  PLI  schemes,  except fermentation based products under PLI Scheme for Bulk Drugs, for which, FY 2023-24 is the first year of Production . As on date, under the PLI scheme for Pharmaceuticals , an incentive amount of Rs.363 Cr has been released under the scheme.

The list of applicant firms selected under these three PLI schemes are available in the Department  website  at  https://pharmaceuticals.gov.in/schemes  under  the  respective  PLI scheme.

## Annexure-I

## Details  of  Critical  KSMs  /  DIs  /APIs  Ingredients  approved  under PLI  scheme  for Promotion of Domestic Manufacturing of Critical KSMs / DIs / APIs in India

|   Sl. No. | Target Segment or Category of KSMs / DIs / APIs             | Products approved under the PLI scheme                                                                                                                                                                                                                                                                         |
|-----------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|         1 | Key Fermentation Based KSMs /Drug Intermediates             | Penicillin G, 7 - ACA and Clavulanic Acid                                                                                                                                                                                                                                                                      |
|         2 | Fermentation Based Niche KSMs / Drug Intermediates / APIs   | Betamethasone, Dexamethasone, Prednisolone, Rifampicin and Clindamycin Base.                                                                                                                                                                                                                                   |
|         3 | Key Chemical Synthesis Based KSMs/Drug Intermediates        | 1,1 Cyclohexane Diacetic Acid (CDA), Para amino phenol and Dicyandiamide (DCDA)                                                                                                                                                                                                                                |
|         4 | Other Chemical Synthesis Based KSMs/Drug Intermediates/APIs | Meropenem, Atorvastatin, Olmesartan, Aspirin, Ritonavir, Lopinavir, Acyclovir, Carbamazepine, Oxcarbazepine, Vitamin B6, Valsartan, Losartan, Levofloxacin, Ofloxacin, Diclofenac Sodium, Carbidopa, Levodopa, Sulfadiazine, Ciprofloxacin, Vitamin B1, Telmisartan, Levetiracetam, Norfloxacin and Artesunate |

## Details of the Sales reported by the PLI applicants under PLI scheme for Promotion of Domestic Manufacturing of Critical KSMs / DIs / APIs in India

| S. No.   | Product                             |   Total Sales (Apr 22 - Dec 22) (₹ in crore) | Total Sales Quantity (Apr 22 - Dec 22) (MT)   |
|----------|-------------------------------------|----------------------------------------------|-----------------------------------------------|
| 1        | 1,1 Cyclohexane Diacetic Acid (CDA) |                                         2.62 | 28.54                                         |
| 2        | Para Amino Phenol                   |                                       177.97 | 3,695.00                                      |
| 3        | Para Amino Phenol                   |                                        31.95 | 0.33                                          |
| 4        | Sulfadiazine                        |                                        26.79 | 115.63                                        |
| 5        | Telmisartan                         |                                         2.81 | 4.48                                          |
| 6        | Atorvastatin                        |                                        86.85 | 66.97                                         |
| 7        | Carbamazepine                       |                                         0.39 | 0.47                                          |
| 8        | Oxcarbazepine                       |                                        47.95 | 41.68                                         |
| 9        | Norfloxacin                         |                                         0.2  | 0.58                                          |
| 10       | Ofloxacin                           |                                         0.91 | 2.66                                          |
| 11       | Carbidopa                           |                                         0.15 | 0.03                                          |
| 12       | Levofloxacin                        |                                        11.31 | 16.20                                         |
| Total    | Total                               |                                       389.89 | 3,972.55                                      |

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