Lok Sabha Question No. 354 (UNSTARRED), answered on 2023-02-03
Subject: Active Pharmaceutical Ingredient
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Pocha Brahmananda Reddy

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

LOK SABHA UNSTARRED QUESTION No. 354 TO BE ANSWERED ON THE 3 rd  February, 2023

## Active Pharmaceutical Ingredient

## 354. SHRI POCHA BRAHMANANDA REDDY:

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

- (a) the quantum of Active Pharmaceutical Ingredient (API) manufactured at domestic level in the country;
- (b) whether there has been any change in the production after the introduction of Production Linked Incentive scheme for APIs;
- (c) if so, the details thereof and if not, the reasons therefor; and
- (d) the details of other steps taken/proposed to be taken to promote domestic manufacturing of APIs in the country?

## ANSWER

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

- (a):  While the quantum of Active Pharmaceutical Ingredient (API) manufactured domestically is not available with the Department, however, the quantity and the value of Bulk Drugs and Drug Intermediates imported and exported during the last three  years, which also gives an indication of the domestic manufacturing, are as under:
- (b)  and  (c):  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  incentives  for  41 identified products. Out of these, 21 projects have already been commissioned.

|                              | Import        | Import           | Export        | Export           |
|------------------------------|---------------|------------------|---------------|------------------|
| Year                         | Quantity (MT) | Value (In Rs Cr) | Quantity (MT) | Value (In Rs Cr) |
| 2019-20                      | 3,64,433      | 24,172           | 2,71,544      | 2,75,33          |
| 2020-21                      | 3,90,476      | 28,529           | 3,24,331      | 3,28,57          |
| 2021-22                      | 4,00,642      | 35,249           | 4,53,130      | 3,33,20          |
| 2022-23(upto November, 2022) | 2,91,782      | 27,209           | 2,82,978      | 2,41,30          |

Source:

DGCIS, Ministry of Commerce and Industry

Under  the  Production  Linked  Incentive  (PLI)  Scheme  for  promotion  of  domestic manufacturing  of  Bulk  drugs,  the  current  FY  22-23  is  the  first  year  of  production  for  the chemical  synthesis  based  Bulk  drugs  and  FY  23-24  is  the  first  year  of  production  for fermentation based bulk drugs.

The PLI Scheme provides for submission of final estimates for sales in a FY by all PLI participants after the end of that Financial Year. Meanwhile, the details of production and sales as submitted by seven applicants for the first half year of the FY 22-23 for seven APIs viz., Para-Amino  Phenol,  Atorvastatin,  Levofloxacin,  Oxcarbazepine,  etc,  indicate  a  total  sale quantity of 3,240.92 MT.

- d.  The  other  Programmatic  interventions  which  are  under  implementation  to  support  the industry for domestic manufacturing of APIs are as follows:
- i. Production Linked Incentive 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 incentives to 55 selected applicants for manufacturing of identified products under three categories for a period of six years. The eligible drugs under this scheme include APIs among other categories of pharmaceutical products.
- ii. Scheme for Promotion of Bulk Drug Parks, with a financial outlay of Rs. 3,000 crores and the tenure from FY 2020-2021 to FY 2024-25, provides for financial assistance for creation of common infrastructure facilities to three States which have been selected under the scheme viz Gujarat, Himachal Pradesh and Andhra Pradesh. The industrial units setting up plants for APIs in these Parks are to be benefited from the common infrastructure developed under the scheme, in order to decrease the manufacturing cost and increase their competitiveness.

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