Lok Sabha Question No. 2139 (UNSTARRED), answered on 2022-07-29
Subject: Research and Development of Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Manoj Kishorbhai Kotak, Raksha Nikhil Khadse

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

LOK SABHA UNSTARRED QUESTION NO. 2139 TO BE ANSWERED ON THE 29 th  July, 2022

## Research and Development of Drugs

## 2139.   SHRI MANOJ KOTAK: SHRIMATI RAKSHA NIKHIL KHADSE:

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

- (a)  whether  the  Government  has  launched  any  programme  or  policy  for  Research  and Development (R&D) of drugs through various schemes;
- (b) if so, the details thereof along with the new drugs developed, R&D expenditure of Indian pharmaceutical companies/Public Sector Undertakings (PSUs) during the last three years, yearwise; and
- (c)  whether  National  Institutes  of  Pharmaceutical  Education  &  Research  (NIPERs)  has conducted research in various pharma specializations and if so, the details thereof?

## ANSWER

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

(a)  and  (b):  Research  and  Development  (R&D)  in  pharma  sector  is  done  by  number  of institutions and organizations under various scientific Ministries/ Departments as well as by pharmaceutical companies.

Department  of  Pharmaceuticals  (DoP)  has  set  up  seven  National  Institutes  of Pharmaceutical Education & Research (NIPERs) as institutes of national importance to nurture and promote quality and excellence in pharmaceutical education and research in India, which besides imparting postgraduate and doctorate education, conduct high end research in various pharma  specializations.  DoP  has  also  set  up  an  Inter-  Departmental  Committee  (IDC)  to periodically review and coordinate research work undertaken by various organizations under different  Ministries/  Departments  so  as  to  ensure  optimum  utilization  of  funds  and  avoid overlapping and duplication of efforts and resources.

Department of Biotechnology (DBT), along with its Public Sector Undertaking (PSU) Biotechnology Industry Research Assistance Council (BIRAC) has facilitated implementation of Research and Development (R&D) projects for drug discovery in the areas of Tuberculosis (TB), Anti-Microbial Resistance (AMR), Diabetes, Cancer, Wound management, Autoimmune disorders and Rare Diseases, through the regular schemes of DBT and BIRAC.

The year-wise details of the fund disbursements by BIRAC to grantees during the last 3 years to support R&D projects for drug development are as follows:

|                                |   2019-20 |   2020-21 |   2021-22 |   Total |
|--------------------------------|-----------|-----------|-----------|---------|
| Amount Released ( Rs in Lakhs) |    826.72 |    498.13 |    419.13 | 1743.98 |

Council of Scientific and Industrial Research (CSIR) through its various constituent laboratories is engaged in the research and development of the process technologies for Active Pharmaceutical Ingredients (API) and intermediates. CSIR has approved various significant projects, including projects on basic research, in the area of drug discovery and development worth about Rs. 284.88 cr. for the period 2020-21 to 2025-26.

The details of R&D expenditure incurred by pharmaceutical companies are not readily available with the department.  As regard pharma PSUs under DoP, it is informed that all of them have been identified for closure or strategic sale. The details of R&D expenditure of three functional PSUs (KAPL, HAL & BCPL) under DoP are as under: -

| PSU                                                |   2019-20 |   2020-21 |   (Rs. in Lakh) 2021-22 |
|----------------------------------------------------|-----------|-----------|-------------------------|
| Karnataka Antibiotics &Pharmaceuticals Ltd. (KAPL) |    125.48 |     35.88 |                   41.24 |
| Hindustan Antibiotics Ltd. (HAL)                   |    127.86 |     97    |                   92.66 |
| Bengal Chemicals &Pharmaceuticals Ltd. (BCPL)      |     11    |     15    |                   16    |

(c):    NIPERs  are  actively  &  dedicatedly  engaged  in  cutting-edge  advanced  translational pharmaceutical  research  in  various  pharma  specializations.  The  areas  of  research  include cancer, diabetes, Neurodegenerative  Disease,  TB,  Phytopharmaceuticals,  New  process development of Generic API molecules, Drug Delivery System, development of Nano-drug Formulations etc.

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