Lok Sabha Question No. 373 (STARRED), answered on 2018-03-21
Subject: Allocation of Fund to CSIR
Ministry: SCIENCE AND TECHNOLOGY
Asked by: PREM DAS RAI

## GOVERNMENT OF INDIA MINISTRY OF SCIENCE AND TECHNOLOGY DEPARTMENT OF SCIENTIFIC AND INDUSTRIAL RESEARCH

## LOK SABHA

STARRED QUESTION No. *373

(TO BE ANSWERED ON 21.03.2018)

## ALLOCATION OF FUND TO CSIR

## *373.  SHRI PREM DAS RAI:

Will the Minister of SCIENCE AND TECHNOLOGY be pleased to state:

- (a) the percentage hike in allocation to CSIR under the Union Budget 2018;
- (b) whether the budgetary allocation to CSIR is sufficient to fund the research in new drugs for kala-azar, filaria, leprosy and tuberculosis;
- (c) if so, the details thereof and if not, the manner in which the Government proposes to fund and support such research; and
- (d) the achievements made by CSIR in making affordable drugs for the above
- diseases?

## ANSWER

## MINISTER OF SCIENCE AND TECHNOLOGY AND EARTH SCIENCES (DR. HARSH VARDHAN)

- (a) Madam, the Council of Scientific and Industrial Research (CSIR) has been allocated Rs. 4734.71 crore (Budget Estimate) for the Financial Year (FY) 2018-19.  The  budget  for  FY  2017-18  was  Rs.  4582.12  crore  (Revised Estimate). This corresponds to a budgetary hike of 3.33% compared to that in 2017-18.
- (b),  (c)&(d)  Yes,  Madam,  considering  the  spectrum  and  quantum  of  R&D activities  being  pursued  by  the  CSIR  constituent  laboratories  which range  from  studies  that  lead  to  better  understanding  of  molecular mechanisms  to  identifying potential drug targets to new  disease diagnostics to drug molecules and new formulations.

CSIR laboratories carry out focused R&D efforts in the infectious disease area,  particularly  tuberculosis  and  leishmaniasis  (Kala-azar),  and  to  a smaller extent in the area of filariasis.

An important intervention developed for tuberculosis by CSIR jointly with Cadila  Pharmaceuticals,  Ahmedabad,  is  a  drug  named  Risorine.  It  is  a novel formulation of Rifampicin with piperine, the bio-enhancer based on knowledge  derived  from  Ayurveda.  The  drug  is  marketed  by  Cadila Pharmaceuticals Ltd, Ahmedabad since 2009. The cost of a single day dose of Risorine kit (Rifampicin-200mg, Isoniazid-300mg, Piperine-10mg,

Ethambutol-800mg,  Pyrazinamid-750mg)  is  Rs.  14.50.  The  annual  sales (2015 and 2016) of RISORINE CAP 10X6 CAP and RISORINE KIT 30X1 KIT is about Rs 100 lakhs, each. Under  the  CSIR-NMITLI  programme,  a  battery  operated  hand  held microPCR  for  diagnosis  of  various  diseases  has  been  developed.  The diseases  which  can  be  diagnosed  are:  Tuberculosis,  Malaria,  Dengue, Chikungunya, Hepatitis  B  and  H1N1.  The  product  is  available  in  Indian and global markets. An anti-leishmanial lead compound 96/261 has been identified for further development. No  new  drug  candidate  for  filariasis  is  currently  being  pursued  by  the CSIR. Some  key  achievements  of  CSIR  in  the  areas  related  to  tuberculosis, leishmaniasis and filariasis from recent past are given at Annexure-1.

## Key  achievements  of  CSIR  in  the  areas  related  to  tuberculosis, leishmaniasis and filariasis from recent past

##  Tuberculosis:

-  Developed a metabolite (non-nucleic acid) biomarker based novel TB  diagnostic  kit  for  sensitive  M.  tuberculosis  (can  detect  Mtb missed  by  smear  microscopy)  and  specific  (to  Mtb  in  sputum samples). The technology has been licensed to a start-up company (Annweshan SciTech Pvt. Ltd.) for further development;
-  Developed  a  viable  new  process  for  Bedaquiline,  a  drug  for treating multi-drug-resistant tuberculosis (TB);
-  Identified novel-protein-protein-interactions essential for virulence regulation of Mtb which can be pursued as unique targets of antimycobacterial drugs/ entities;
-  Shown  that  (a)  biofilm  harbours  a  population  of  phenotypically drug-resistant Mtb and (b) cellulose is a major component of the Mtb biofilms;
-  Generated  fusion  constructs  expressing  reporter  protein  along with virulence factors for tuberculosis;
-  Identified  miRNA  and  cytokine  signatures  in  body  fluids  for  TB diagnostics; and
-  Identified new hits/leads:
-  Nano-molar  MmpL3  transporter  protein  inhibitors:  NDS100244 and NDS-100529;
-  10-α/β-D-arabinofuranosyl-undecenes based nanomolar cellwall synthesis inhibitor;
-  11 leads (IICT-1 to IICT-11) - pursuing 3 leads (IICT-3, IICT4, and IICT-8) for further investigations;
-  IIIM/019/Dinitroimidazole  derivative  for  treatment  of  MDR tuberculosis;
-  IIIM/1132+rifampicin combination for improved bioefficacy;

##  Leishmaniasis:

-  Developed serum and urine-based kits for diagnosis of human and canine  visceral  leishmaniasis  (VL)  and  post  kala-azar  dermal leishmaniasis (PKDL);
-  A  colloidal  gold-based  LFT  for  detecting  serum  and  urine antibodies specific to L. donovani purified antigen, Lag has been developed. The LFTs are undergoing validation in the clinical settings;
-  Identified new hits/leads:

-  Identified anti-leishmanial lead compound  96/261: Has potent  activity  against  Leishmania  donovani  both  in  vitro and  in  vivo.  Dose-dependent  response  in  the  hamster-  L. donovani model has been seen and pharmacokinetic analysis has been carried out. Early toxicity studies indicate  a  high  tolerated  dose  suggesting  a  good  safety margin;
-  Anti-leishmanial lyophilized liposomal amphotericin B (AmB)  formulation:  detailed  toxicity,  immunomodulation and anti-leishmanial studies need to be carried out;
-  Identification  and  development  of  META1  as  a  druggable  target against leishmaniasis: Possibly essential for Leishmania survival; Potential virulence factor; Role in deciding which  tissue to infect/modulates  secretary  process  and  reversible  changes  in leishmania morphology;
-  Generated a clear understanding of the virulence of leishmaniasis through regulation of parasite genes; and
-  Developed a novel liposomal adjuvant formulation for induction of long term protective response in leishmaniasis;

##  Filariasis:

-  Mapped the genome (draft) of parasitic nematode, Setaria digitate (filariasis).

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