Lok Sabha Question No. 2358 (UNSTARRED), answered on 2021-08-03
Subject: API Manufacturing
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Mitesh Rameshbhai (Bakabhai) Patel

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

LOK SABHA UNSTARRED QUESTION No. 2358

TO BE ANSWERED ON THE 3 rd  AUGUST, 2021

## API Manufacturing

## †2358. SHRI MITESH RAMESHBHAI PATEL (BAKABHAI):

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

- (a)  the  quantity  of  Active  Pharmaceutical  Ingredient  (API)  manufactured  at  domestic  level including the details thereof;
- (b) the details of efforts made by the Government to promote API manufacturing plants in the country; and
- (c) whether the Government has set any special target for the coming years in this regard and if so, the details thereof?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI MANSUKH MANDAVIYA)

- (a):  The quantity of API manufactured domestically is not readily available. However, the size of API and Intermediates market in India is estimated to be Rs. 96,000 crore in FY 2019-20. Further,  as  per  data  maintained  by  Directorate  General  of  Commercial  Intelligence  and Statistics (DGCIS), the quantity and value of API imported and exported in FY 2020-21 is given below:
- (b)  to  (c):  The  Department  of  Pharmaceuticals  is  implementing  the  following  three  (03) schemes for promoting domestic manufacturing of APIs to ensure their sustainable domestic supply and make India Atma Nirbhar (self-reliant):
- (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: The scheme provides for financial incentives to manufacturers selected under the scheme for manufacturing of 41 Key Starting Materials (KSMs)/  Drug  Intermediates  (DIs)  and  Active  Pharmaceutical  Ingredients  (APIs).  The incentives  will  be  provided  on  incremental  sales  to  selected  participants  for  a  period  of  6 years. The total financial outlay of the scheme is Rs. 6,940 crore and the tenure of the scheme is from FY 2020-2021 to 2029-30.
- (II) Scheme for Promotion of Bulk Drug Parks: The scheme provides for grant-in-aid to three  (03)  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  financial  outlay  of  the  Scheme  is  Rs.  3000  crore  and the tenure of the Scheme is from FY 2020-21 to 2024-25.
- (III) Production Linked Incentive Scheme for Pharmaceuticals : The scheme provides for financial  incentives  to  manufacturers  selected  under  the  scheme  for  manufacturing  of  Key Starting Materials (KSMs)/ Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs)  amongst  other  categories  of  formulations.  The  incentives  will  be  provided  on incremental sales to selected participants for a period of 6 years. The total financial outlay of the scheme is Rs. 15,000 crore and the tenure of the scheme is from FY 2020-2021 to 202829.

|         | Quantity (In MT)   |   Value (Rs. In crore) |
|---------|--------------------|------------------------|
| Imports | 3,90,476           |                  28529 |
| Exports | 3,24,331           |                  32856 |

The detailed guidelines of the above three schemes are available on the website of the Department under the tab 'schemes'.

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