Lok Sabha Question No. 29 (UNSTARRED), answered on 2022-02-02
Subject: API Manufacturers
Ministry: COMMERCE AND INDUSTRY
Asked by: Unmesh Bhaiyyasaheb Patil, Rajendra Dhedya  Gavit, Aparupa  Poddar, Krishna Pal Singh Yadav, Shrikant Eknath Shinde, Sujay Radhakrishna Vikhepatil, Heena Vijaykumar Gavit

## GOVERNMENT OF INDIA MINISTRY OF COMMERCE & INDUSTRY (DEPARTMENT OF COMMERCE)

## LOK SABHA UNSTARRED QUESTION NO. 29 TO BE ANSWERED ON 2 nd  FEBRUARY, 2022

## API MANUFACTURERS

## 29. SHRI UNMESH BHAIYYASAHEB PATIL:

SHRI RAJENDRA DHEDYA GAVIT:

SHRIMATI APARUPA PODDAR:

DR. KRISHNA PAL SINGH YADAV:

DR. SHRIKANT EKNATH SHINDE:

DR. SUJAY RADHAKRISHNA VIKHE PATIL:

DR. HEENA GAVIT:

Will the Minister of COMMERCE & INDUSTRY ( वाणिज्य एवं उद्योग मंत्री ) be pleased to state:

- (a) the details of policies and schemes to bolster the Active Pharma Ingredients (API) manufacturers in India;
- (b) the details of funds allocated, sanctioned and disbursed during the past five years for the purpose, State/Union Territory-wise, specially in the State of Maharashtra, West Bengal and Madhya Pradesh;
- (c) the details of API production State-wise and the manner in which the schemes, policies and funds allocated have bolstered the manufacturing of API during the past five years;
- (d) the details of the mechanism for imposing subsequent duties on competitive market along with the projected benefits to the API manufacturers; and
- (e) the details of any other changes being stipulated for improving the status of API manufacturers, State/ Union Territory-wise, specially in the State of Maharashtra, West Bengal and Madhya Pradesh?

## ANSWER

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## THE MINISTER OF STATE IN THE MINISTRY OF COMMERCE AND INDUSTRY (SMT. ANUPRIYA PATEL)

- (a) to (e):   India is the third largest player globally in Pharmaceuticals in terms of volume and is the largest supplier of low cost generics and vaccines to the world.  The Government is also taking steps in the form  of  various  schemes  to  attract  investments  in  pharmaceuticals  and  medical  devices  sectors, including for the Active Pharma Ingredients (API) manufacturing.

The details of the scheme bolstering  the Active Pharma Ingredients (API) manufacturers in India is at Annexure.

## Annexure to Lok Sabha Unstarred Question No.29 to be answered on 02.02.2022 .

(i)  Production  Linked  Incentive  Scheme  for  promotion  of  domestic  manufacturing  of  critical  Key Starting  Materials  (KSMs)/  Drug  Intermediates  (DIs)/  Active  Pharmaceutical  Ingredients  (APIs)  in India.

-  The  Union  Cabinet  approved the  scheme  on  20.03.2020  with  the  objective  to  boost  domestic manufacturing of identified KSMs, DIs and APIs.The tenure of the scheme is from FY 2020-21 to 2029-30, with the total financial outlay of Rs. 6,940 crores.
-  The Financial incentive under the sub-scheme is provided on sales of 41 identified products categorized into four Target Segments.

## (ii)   PLI Scheme for Pharmaceuticals: -

-  Eligible drugs under this scheme approved on 24.02.2021 include Active Pharmaceutical Ingredients among other categories of pharmaceutical products. The Operational Guidelines have been issued on 1.6.2021.
-  The total financial outlay of the scheme is Rs. 15,000 crore and the tenure of the scheme is from FY 2020-2021 to 2028-29.

## (iii)     Scheme for Promotion of Bulk drug parks

-  The scheme of 'Promotion of Bulk Drug Parks' approved on 20th March, 2020. The scheme provides for support to establish three (03) Bulk Drug Parks for creation of world class Common Infrastructure Facilities (CIF). Guidelines of the scheme were notified on 27 th July 2020.
-  The total financial outlay of the scheme is Rs. 3000 crores. The tenure of the scheme is from FY 20202021 to FY 2024-2025.

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## ANNEXURE