Lok Sabha Question No. 3741 (UNSTARRED), answered on 2017-08-09
Subject: Development of New Drugs
Ministry: SCIENCE AND TECHNOLOGY
Asked by: George Baker, ANIL SHIROLE

## GOVERNMENT OF INDIA MINISTRY OF SCIENCE AND TECHNOLOGY DEPARTMENT OF SCIENCE AND TECHNOLOGY

## LOK SABHA

UNSTARRED QUESTION NO.3741

TO BE ANSWERED ON 9/08/2017

## DEVELOPMENT OF NEW DRUGS

## 3741.  SHRI GEORGE BAKER: SHRI ANIL SHIROLE:

Will the Minister of SCIENCE AND TECHNOLOGY òãðìððÐð ¡ðøÜ ÑßðøÌðð÷ò±ð¨îó Ùðüëðó be pleased to state:

- (a) the steps taken by the Government for development of new drugs across the country so far;
- (b) the details of the target set and achievements made in this regard, State/ UT-wise;
- (c) whether the Government has tied up with some foundation/agencies in this regard; and
- (d) if so, the details thereof along with the results?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF SCIENCE AND TECHNOLOGY AND MINISTER OF STATE IN THE MINISTRY OF EARTH SCIENCES (SHRI Y.S. CHOWDHARY)

òãðìððÐð ¡ðøÜ ÑßðøÌðð÷ò±ð¨îó ÙðüëððâðÚð Ùð÷ü Üð¸Úð Ùðüëðó +ÉÉè® ÑðöÆãðó òãðìððÐð ÙðüëððâðÚð Ùð÷ü Üð¸Úð Ùðüëðó

(gÉÉÒ ´ÉÉ<Ç. AºÉ. SÉÉèvÉ®ÉÒ)

- (a) Several Government institutions like CSIR and ICMR labs, companies and academic institutes are  undertaking  research  for  the  development  of  new  drugs  in  the  country.  The  areas  of  research undertaken by these institutions and companies include anti-cancer, anti-tuberculosis, cardiovascular, anti-diabetic vaccines and other biologicals etc. Government has taken several steps for strengthening Research  &  Development  in  pharmaceuticals  sector  through  fiscal incentives to  R&D  units, streamlining of procedures concerning development of new drug molecules, clinical research and new drug delivery systems leading to new R&D set-ups with excellent infrastructure in the field of drug discovery.

The Department of Science & Technology (DST) is supporting drug research through Drugs institutional collaborative  R&D  projects,  creating  state-of-the-art  national  facilities  in  research  laboratories  and academic institution and soft loan with a simple interest of 3% per annum to pharma industry R&D

and Pharmaceuticals Research Programme. This programme supports industry projects and grant-in-aid to industries in clinical trials for neglected diseases.

Council  of  Scientific  and  Industrial  Research  (CSIR)  through  its  constituent  laboratories namely  CSIR-Central  Drug  Research  Institute,  CSIR-Indian  Institute  of  Chemical  Technology, CSIR-Institute of Microbial Technology,   CSIR-Indian Institute of Toxicology Research etc has been pursuing  R&D  activities  in  the  domain  of  drugs  and  pharmaceuticals  with  emphasis  on  affordable healthcare.  In  doing so,  CSIR  efforts  are  focused  on:  understanding  disease  biology;  disease diagnostics;  drug  discovery  and  development;  high  end  chemistry-based  process  development  for generic drugs; and creating innovative platforms for enhancing the innovation in the domain. Department  of  Bio  Technology  (DBT)  has  established  a  Drug  Discovery  Research  Centre (DDRC) - a multi-disciplinary research unit, with a focus on new drug development in 2013 vs. a niche centre of the Translation Health Science and Technology Institute (THSTI).  Biotechnology Industry Research Assistance Council (BIRAC) - a public sector unit is also supporting development of new drugs  in  the  areas  of  diabetes,  antimicrobial  resistance  and  neurodegenerative  diseases  through  its different  schemes  like        Biotechnology  Industry  Partnership  Programme  (BIPP),  Biotechnology Ignition  Grant  (BIG)  and  small  Business  Innovation  Research  Initiative  (SIBRI)  by  encouraging partnerships between industry and academia. Technology  Development  Board  (TDB),  a  statutory  body  of  the  Department  of  Science  and Technology provides equity capital or any other financial assistance to industrial concerns and other agencies  including  R&D  institutions  attempting  commercial  application  of  indigenous  or  adapting imported technology for wider domestic application in various sector which also includes development of new drugs. Department of Pharmaceuticals (DOP) notified 'National Pharmaceuticals Pricing Policy' with the objective to put in place a regulatory framework for pricing of drugs so as to ensure availability of required  medicines  -  'essential  medicines'  at  reasonable  prices  even  while  providing  sufficient opportunity for innovation and competition to support the growth of pharma industry. (b) Following are some of the products developed under the projects supported by the Drugs and Pharmaceuticals  Research  Programme  (DPRP)  of  DST:  (i)  BONISTA  -  Teriparatide  Injection (recombinant human parathyroid hormone) for  treatment of  Osteoporosis;  (ii)  RHOCLONE  -  AntiRho-D Immunoglobulin Injection (Monoclonal) 300mcg developed for Hemolytic disease of the new born  (HDN);  (iii)  SYNRIAM  -  a  new  anti-malarial  drug  for  the  treatment  of  uncomplicated  P. falciparum  malaria;  (iv)  Mycidac  -  a  drug  developed  for  advanced    Non  small  Cell  Lung  Cancer (NSCLC) etc. At  Biotechnology  Industry  Research  Assistance  Council  (BIRAC)  the  successful  outcomes include clinical development of TRC 150094 for the treatment of cardiovascular risk factors defined by metabolic  syndrome  and  Galnobax  for  the  treatment  of  diabetic  foot  ulcer  which  have  successfully completed Phase II clinical trials.  The projects supported for the development of novel inhibitors of fatty acid biosynthesis and DNA gyrase for the treatment of drug resistant bacterial infections have successfully completed animal studies. Current efforts at Drug Discovery Research Centre (DDRC) are focused on development of SPR113, a lead small molecule under advance preclinical evaluation (IND enabling studies) with the potential to treat  MDR/XDR  and  TDR  form  of  tuberculosis.    DDRC  has  also  developed  a  lead  molecule  that displays  potent  activity  against  HIV-1  infection  in  cells.    The  current  emphasis  is  to  validate  and optimize  this  lead  molecule.  It  is  also  developing  a  lead  candidate  with  activity  against  cardiac hypertrophy. (c)  &  (d):  Government  supports  projects  to  Government  funded  labs  and  institutes,  academia  and

Indian Pharma Companies.

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