Lok Sabha Question No. 1707 (UNSTARRED), answered on 2019-07-02
Subject: Pharmaceutical Research
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Parvesh Sahib Singh

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

LOK SABHA UNSTARRED QUESTION No. 1707 TO BE ANSWERED ON THE 2 nd  July, 2019

## Pharmaceutical Research

## 1707.   SHRI PARVESH SAHIB SINGH:

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

- (a)  whether  there  is  any  disease/virus/  epidemic  in  the  country  for  which  there  is  no drug/antidote available in the country as of June 2019 and if so, the details thereof;
- (b) the details of exclusive pharmaceutical research/inventions carried out in the country during the last five years; and
- (c) the total funds allocated for pharmaceutical research during the said period and the steps taken for promotion of pharmaceutical research and inventions in the country?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

- (a): The Department of Pharmaceuticals has no data regarding any disease/virus/epidemic in the country for which there is no drug/antidote available in the country.
- (b)  &  (C):  The  details of  research and development activities being undertaken in the field of pharmaceuticals research is given at Annexure.

## Annexure referred to in part (b) & (c) of Lok Sabha Unstarred Question No. 1707 for reply on 02.07.2019 raised by Shri Parvesh Sahib Singh regarding 'Pharmaceutical Research'.

(b)  &  (c):  The  details  of  research  and  development  activities  being  undertaken  in  the field of pharmaceuticals research is as following:

-  Council  of  Scientific  &  Industrial  Research  (CSIR) is  implementing  a  Mission Mode Project on Active Pharmaceutical Ingredients to develop innovative and novel processes for soon to be generic nationally important APIs and also for key starting materials  and  intermediates  for  which  Indian  pharmaceutical  industry  is  mainly dependent  on  China  for  its  requirement.  Selected  molecules  are:  Daclatasvir; Ledipasvir;  Nilotinib;  Nicergolin;  alpha-Lipoic  acid;  Sitagliptin;  Sacubitril;  Azelaic Acid; Paracetamol; Ibuprofen; Dolutegravir; Boscalid; Pregabalin; Avibactum.
-  CSIR is implementing Phytopharmaceuticals Mission under which phytopharmaceutical development is being pursued along with related activities such as captive cultivation of medicinal plants including rare and endangered medicinal plants and technology for preparation of standardized extracts. The phytopharmaceutical development is being pursued as per regulatory guidelines of DCGI/AYUSH. Phytopharmaceutical development of Cassia occidentalis for Glucocorticoid-induced osteoporosis, Murraya koenigii for Cervical cancer, Dysoxylum  binectariferum  for  Rheumatoid  arthritis  and  Picrorhiza  kurroa  for  Liver fibrosis is being pursued as per regulatory guidelines of DCG(I). Phytopharmaceutical development of Glycyrrhiza glabra for Diabetes, Cissampelos pareira for Anti-venom, Tinospora coridfolia for Cognitive impairment and Bergenia ciliate for Pain in Rheumatoid arthritis is being pursued as per regulatory guidelines of AYUSH.
-  CSIR  is  also  implementing  Sickle  Cell  Anaemia  Mission  for  Managing  Genetic Burden  of  Sickle  Cell  Anaemia  and  Understanding  Genetic  Basis  of  Differential Response to Hydroxyurea Therapy; Drug discovery and development for management  of  SCA;  Genome  editing  and  stem  cell  research  approach  for  the treatment of SCA; and Development and on-ground implementation of an affordable, accurate and accelerated diagnostic kit.
-  Standardized  extract  of  Dalbergia  sissoo  for  fracture  healing  and  management  of post-menopausal osteoporosis has been launched for marketing on 17 Feb 2016 by our licensee M/s. Pharmanza Herbals Ltd., Gujarat. It is being marketed with brand name Reunion, an Ayurvedic Medicine.
-  Technology  of  novel  osteo-inductive  agent  CDRI  S008-399  as  medicated  bone implant  material  for  fracture  healing  has  been  transferred  to  M/s.  OrthoRegenics Pvt., Ltd., Hyderabad.
-  IND has been filed for the Antithrombotic candidate drug S007-867
-  Advanced level  pre-clinical  regulatory  studies  are  ongoing  for  the  fracture  healing agent CDRI S007-1500. IND to be filed shortly.
-  Development of Non-invasive Premature Birth Prediction Kit
-  Development  of  a  biosimilar  of  Adalimumab  for  treatment  of  rheumatoid  arthritis: scaling-up of upstream and downstream mAb production processes

As per the information received from CSIR, detail of their allocation on pharmaceuticals research is given below:

(Rs. In Lakh)

| Year       |   2015-16 |   2016-17 |   2017-18 |   2018-19 |   19-20 (till date) |
|------------|-----------|-----------|-----------|-----------|---------------------|
| R&D Budget |      6063 |      4608 |      7747 |      9227 |                5252 |

The  Department  of  Science  and  Technology  under  Ministry  of  Science  and Technology has  been  implementing  a  Plan  Scheme  (Drugs  &  Pharmaceuticals Research  Programme  -  DPRP)  since  1994-95  for  promoting  R&D  in  Drugs  & Pharmaceutical Sector with the following objectives:

-  To synergise the strengths of publicly funded R&D  institutions and Indian Pharmaceutical Industry;
-  To create an enabling infrastructure, mechanisms and linkages to facilitate new drug development;
-  To stimulate skill development  of human  resources  in R&D  for drugs and pharmaceuticals;

Under this programme grants-in-aid is extended to Indian Pharmaceutical industries for  clinical  trials  -  Phase-I,  II  and  III  for  neglected  diseases  such  as  Tuberculosis, Malaria,  Kala-Azar,  Filariasis,  etc.  Since  2008-09,  this  programme  supported  four grants-in-aid  projects  to  Indian  Pharma  industries  for  conducting  trials  in  neglected diseases such as malaria, kala-azar etc.

The  total  funds  allocated  to  the  Drugs  &  Pharmaceuticals  Research  Programme (DPRP) during the last five years is 100 Crores

Indian  Council  for  Medical  Research  (ICMR) has  supported  a  total  number  of  20 pharmaceutical  research  projects  during  last  five  years.  ICMR  has  set  up  Technical Advisory group for guidance of taking forward leads of research for product development.

ICMR has released Rs. 2.57 crores for pharmaceutical research.

xxxxx