Lok Sabha Question No. 1133 (UNSTARRED), answered on 2025-07-25
Subject: Promotion of  Pharmaceutical Research
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri P V Midhun Reddy

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

LOK SABHA UNSTARRED QUESTION NO.1133 TO BE ANSWERED ON THE 25 TH  JULY 2025

## Promotion of Pharmaceutical Research

## 1133. Shri P V Midhun Reddy:

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

- (a) whether the Government has taken note of the lack of research in the pharmaceutical sector of the country, if so, the corrective measures taken in this regard;

(b) whether the Government is aware that, as per reports, new medicines, devices, diagnostics, patient aids, and monitoring tools continue to be imported due to lack of its development in the country and often reach the Indian patients several years after they are available to patients in the developed countries;

(c) if so, the steps taken/proposed to be taken by the Government to reduce import dependency and encourage local innovation; and

(d) whether the Government has provided an update regarding the proposed establishment of the campus of the National Institute of Pharmaceutical Education and Research (NIPER) in Visakhapatnam, Andhra Pradesh, which was sanctioned back in 2016, if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF  CHEMICALS  AND FERTILIZERS

(SMT. ANUPRIYA PATEL)

- (a)  to  (c):  Taking  note  of  the  need  to  promote  research  in  the  pharmaceutical  sector  of the country and encourage local innovation, number of measures have been taken, including the following:
- (i) The PRIP scheme has been launched with an outlay of ₹ 5,000 crore to transform India's  Pharma  MedTech  sector  from  cost-  to  innovation-based  growth  by strengthening research and to promote industry-academia linkage for research and development  in  priority  areas  in  drug  discovery  and  development  and  medical devices. Under this, seven Centres of Excellence (CoEs) have been set up, one at each  of  the  seven  National  Institutes  of  Pharmaceutical  Education  and  Research (NIPERs), with total budgetary support to the tune of ₹ 700 crore, to create research infrastructure and promote R&D in identified areas. The CoEs are in the areas of anti-viral and anti-bacterial drug discovery and development, medical devices, bulk drugs, flow chemistry and continuous manufacturing, novel drug delivery system, phytopharmaceuticals  and  biological  therapeutics,  and  have  so  far  approved  104 research projects  under the scheme  and have filed two patents. The scheme also includes an outlay of ₹4,250 crore for support to industry and startups, including in collaboration with  academia, for undertaking  research and innovation projects in priority areas;
- (ii) The Department of Pharmaceuticals has set up seven NIPERs as institutes of national importance.  These,  besides  imparting  postgraduate  and  doctoral  programmes, conduct high-end research in various pharmaceutical specialisations;
- (iii) Support to research and innovation for development of innovative technologies and products for affordable healthcare by the Department of Biotechnology (DBT);
- (iv) To encourage local innovations, the Drugs (Prices Control) Order, 2013 provides for exemption from price control to formulations developed through indigenous R&D for certain period, subject to fulfilment of certain conditions;
- (v) Schemes and initiatives of the Biotechnology Industry Research Assistance Council (BIRAC), a public sector enterprise of the Department of Biotechnology, to support development of affordable products and technologies by startups, small and medium enterprises and large companies;
- (vi) The  constituent  laboratories  of  the  Council  of  Scientific  and  Industrial  Research (CSIR)  are  engaged  in  development  of  new  drugs,  process  technologies  and diagnostics, necessary infrastructure and human resources;
- (vii) The Department of Science and Technology is promoting R&D  in the pharmaceutical  sector  through  its  Therapeutic  Chemicals  programme  for  the development key starting materials, intermediates and raw materials; and
- (viii) The Indian Council of Medical Research provides financial assistance to different researchers  and  scientists  working  in  its  institutes  under  its  intramural  grants programme and to others through its extramural grants programme, for research in the fields of medicine, public health and allied disciplines.

To  promote  domestic  manufacturing  of  new  medicines,  devices,  diagnostics,  patient  aids, monitoring tools, etc. and reduce import dependency, number of measures have been taken through various schemes, including the following:

- (i) PLI  Scheme  for  promotion  of  domestic  manufacturing  of  critical  Key  Starting Materials  (KSMs)  /  Drug  Intermediates  (DIs)  /  Active  Pharmaceutical  Ingredients (APIs) in India (also known as the PLI Scheme for Bulk Drugs);
- (ii) PLI Scheme for Pharmaceuticals;
- (iii) Scheme for Promotion of Bulk Drug Parks;
- (iv) Strengthening of Pharmaceutical Industry scheme;
- (v) PLI Scheme for Promoting Domestic Manufacturing of Medical Devices;
- (vi) Scheme for Promotion of Medical Devices Parks; and
- (vii) Scheme for Strengthening Medical Device Industry.

The PLI Scheme for Bulk Drugs, which has a total budgetary outlay of ₹6,940 crore, aims to avoid disruption in supply of critical active pharmaceutical ingredients (APIs) used to make critical drugs for which there are no alternatives by reducing supply disruption risk due to excessive dependence on single source. As of March 2025, the committed investment of ₹3,938.5  crore  under  projects  approved  under  the  scheme  for  investment  over  the  six-year production period of the scheme stands substantially exceeded with cumulative investment of ₹4,570 crore made by the scheme's third year. Further, production capacity has been created for 25 APIs/KSMs/DIs. Under the scheme, cumulative sales of ₹1,817 crore have been reported over  the  period  from  FY2022-23  till  FY2024-25,  including  exports  of  ₹455  crore,  thereby avoiding imports worth ₹1,362 crore.

The  PLI  Scheme  for  Pharmaceuticals  aims  to enhance  India's  manufacturing capabilities by increasing investment and production in the sector and contributing to product diversification to high-value goods in the pharmaceutical sector. It incentivises production of high-value medicines such as biopharmaceuticals, complex generic drugs, patented drugs or drugs nearing patent expiry, auto-immune drugs, anti-cancer drugs, etc. as well as production of APIs/KSMs/DIs other than those notified under the PLI Scheme for Bulk Drugs, thereby contributing to self-reliance. The scheme has enabled enhanced investment and production in eligible products. As of March 2025, the committed investment of ₹17,275 crore targeted over the six-year period of the scheme stands substantially exceeded with cumulative investment of ₹37,306 crore made by the scheme's third year, and cumulative sales of approved products of ₹2,66,528 crore have been made, including exports of ₹1,70,807 crore.

Under the Scheme for Promotion of Bulk Drug Parks, which has a total budgetary outlay  of  ₹3,000  crore,  three  parks  have  been  approved  and  are  at  various  stages  of development in the States of Andhra Pradesh, Gujarat and Himachal Pradesh, through their respective State Implementing Agencies. The total project cost of these is over ₹ 6,300 crore, with Central assistance to the tune of ₹1,000 crore each for creation of common infrastructure facilities. These parks would offer land and utilities such as power, water, effluent treatment plant,  steam,  solid  waste  management,  warehouse  facilities  at  a  subsidised  rate.  The  State Implementing Agencies of the three States are also offering fiscal incentives in the form of capital subsidy on fixed capital investment, interest subsidy, State Goods and Services Tax reimbursement, exemption of stamp duty and registration charges, etc. Further, the scheme provides that applicants for allotment of land in the parks to set up units for manufacturing products prioritised in the PLI Scheme for Bulk Drugs will have priority in land allotment. The Strengthening of Pharmaceutical  Industry scheme supports  realisation of the vision of Atmanirbhar Bharat through the following sub-schemes:

- (i) Assistance to Pharmaceutical Industry for Common Facilities (API-CF): The scheme aims to strengthen the existing infrastructure facilities by providing financial assistance to pharmaceutical clusters for creation of common facilities. It helps create tangible assets as common facilities, such as testing labs, R&D labs, effluent treatment plants and  training  centres,  thereby  supporting  the  long-term  viability  and  growth  of  the clusters by enabling them to develop and leverage shared resources. Under API-CF, projects with total grant-in-aid to the tune of ₹ 139.33 crore to pharmaceutical clusters have  been  approved  for  creation  of  common  facilities  and  are  at  various  stages  of execution.  Once  these  common  facilities  are  created,  they  are  expected  to  provide access  to  common  facilities  to  around  1,300  existing  pharmaceutical  units,  besides catalysing the augmentation of capacities at these clusters through the setting up of new pharmaceutical units and expansion of existing units.
- (ii) Revamped Pharmaceutical Technology Upgradation Assistance Scheme  (RPTUAS): The  scheme  aims  to  support  upgrade  of  production  facilities  of  small  and  medium pharmaceutical companies having average turnover of less than ₹ 500 crore, to attain the standards specified in the revised Schedule M to the Drugs Rules, 1945 and the World Health Organization - Good Manufacturing Practices  (WHO-GMP), thereby improving  their  competitiveness,  both  domestically  and  globally.  Under  this,  till 1.7.2025, support for upgrade to attain the said standards has been approved for 142 micro, small and medium pharmaceutical companies, with total sanctioned amount of ₹135.8 crore.

The PLI Scheme for Promoting Domestic Manufacturing of Medical Devices has a total budgetary outlay of ₹3,420 crore and a five-year performance-linked incentive period from FY2022-23 to FY2026-27. Under the scheme, selected companies are eligible for financial incentive  for  incremental  sales  of  domestically  manufactured  medical  devices  in  the radiotherapy,  imaging  device,  anaesthesia,  cardio-respiratory  and  critical  care  and  implant device  segments,  for  a  period  of  five  years.  So  far,  21  greenfield  projects  have  been commissioned, and production has started for 54 products, which include high-end medical devices on which the country has been highly import-dependent, such as linear accelerators, machines for MRI and CT scans and mammograms, C-arm X-ray machines and ultrasound machines. Till March 2025, cumulative eligible sales ₹10,413.40 crore have been made under the scheme, including export sales worth ₹5,002 crore.

Under the Scheme for Promotion of Medical Devices Parks, three parks have been approved and are at an advanced stage of development in Greater Noida (Uttar Pradesh), Ujjain (Madhya Pradesh) and Kanchipuram (Tamil Nadu) districts. The total project cost of these is over  ₹871.11  crore,  with  Central  assistance  to  the  tune  of  ₹100  crore  each  for  creation  of common infrastructure facilities, which is expected to enhance industry's competitiveness and reduce production costs through optimisation of resources and economies of scale.

The  Scheme  for  Strengthening  Medical  Device  Industry  has  been  launched  on 8.11.2024  with  a  financial  outlay  of  ₹500  crore.  It  aims  to  strengthen  the  medical  device industry by providing support in critical areas, including manufacturing of key components and accessories, skill development,  support  for  clinical  studies,  development  of  common infrastructure, and industry promotion.

Enabled by these schemes, over the last six financial years, the export of drugs and pharmaceuticals has increased by 59% from US$ 18,300 million in FY2018-19 to US$ 29,046 million in FY2024-25, while that of medical devices has increased by 88%, from US$ 2,138 million in FY2018-19 to US$ 4,014 million in FY2024-25.

(d): No NIPER has been sanctioned at Visakhapatnam.

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