Lok Sabha Question No. 678 (UNSTARRED), answered on 2022-12-09
Subject: Indian Pharma Industry
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Amar Singh

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

LOK SABHA UNSTARRED QUESTION No. 678 TO BE ANSWERED ON THE 9 TH  DECEMBER, 2022

## Indian Pharma Industry

## 678. DR. AMAR SINGH:

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

- (a) whether the Government has chalked out any action plan to ensure that the Indian pharma industry breaks into the top-10 countries in terms of value by 2030, and enter the top-5 club by 2047;
- (b) if so, the details thereof; and
- (c) if not, the reasons therefor?

## ANSWER

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

(a) to (c):  The Government 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.

Various Programmatic interventions to support Pharma and Medical Devices Industries 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,  21  projects  have  already  been commissioned with the installed capacity of 33,895 MT.
- (ii) 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 incentive to 55 selected applicants for manufacturing of identified products under three categories for a period of six years.
- (iii) 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 to three States for establishing Bulk Drug Parks. After evaluation of the proposals received from 13 States, the proposals of the states of Gujarat, Himachal Pradesh and Andhra Pradesh have been finally approved for providing grants-in-aid for creation of common infrastructure facilities in the proposed Bulk Drug Parks.
- (iv) The  Department  is  implementing  the  scheme  of Strengthening  of  Pharmaceutical Industry (SPI), with a financial outlay of Rs. 500 crores and the tenure from FY 20212022 to FY 2025-26 to provide infrastructure support for pharma MSMEs in clusters and to address the issues of technology upgradation of individual pharma MSMEs.
- (v) Under the scheme for Promotion of Medical Devices Parks, final approval for financial assistance of Rs. 100 crore each, has been given to the States of Uttar Pradesh, Tamil Nadu, Madhya Pradesh and Himachal Pradesh for establishment of common facilities in their Medical Device Parks.
- (vi) Under the  Production  Linked  Incentive  (PLI)  Scheme  for  Promoting  Domestic Manufacturing of Medical Devices , with a financial outlay of Rs. 3,420 Cr and with the tenure from FY 2020-21 to FY 2027-28, financial incentives is to be given to selected companies at the rate of 5% of 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. A total of 21 applications/projects have been selected under the scheme. Out of these, 13 projects have been commissioned for 31 products.

The non-schematic interventions are as follows-

- i. In order to attract investments in this sector, the Government has allowed 100% foreign direct  investments  (FDI)  in  medical  devices  sector.  Similarly,  the  Government  has allowed 100% FDI in pharma sector for greenfield projects under automatic route. For the brownfield projects, upto 74%, FDI investments are allowed under automatic route and beyond 74% to 100%, FDI investments are allowed under government approval route.
- ii. In  order  to  redress  the  specific  challenges  of  the  MedTech  Industry,  in  view  of  the diversity  and  multi-disciplinary  nature  of  the  sector,  the  institutional  mechanism  of Standing Forum of Medical Devices Associations, has been set up to deliberate on various issues with all the stakeholders including regulators.

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