Lok Sabha Question No. 6381 (UNSTARRED), answered on 2017-04-12
Subject: Central Drug Research Institute
Ministry: SCIENCE AND TECHNOLOGY
Asked by: KUNWAR HARIBANSH SINGH, SUDHEER GUPTA, SUNIL BALIRAM GAIKWAD, VIJAY KUMAR S.R., GAJANAN CHANDRAKANT KIRTIKAR, T. RADHAKRISHNAN

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

## LOK SABHA

UNSTARRED QUESTION NO. 6381 (TO BE ANSWERED ON 12.04.2017)

## CENTRAL DRUG RESEARCH INSTITUTE

## 6381.   KUNWAR HARIBANSH SINGH:

SHRI SUDHEER GUPTA:

DR. SUNIL BALIRAM GAIWAD:

SHRI S.R. VIJAYAKUMAR:

SHRI GAJANAN KIRTIKAR:

SHRI T. RADHAKRISHNAN:

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

- (a) the  number  of  Central  Drug  Research  Institutes  in  the  country  at  present, State/UT-wise;
- (b) the details of the funds sanctioned, allocated and utilised by these institutes during each of the last three years and the current year, institute-wise;
- (c) the details of the performance of the said institutes so far, institute-  wise;
- (d) whether the Government has given any target to these institutes to develop next generation drugs and if so, the details thereof;
- (e)         whether  any  collaboration  has  been  made with foreign  countries regarding above institutes and if so, the details thereof; and
- (f) the steps taken/being taken by the Government to increase the performance of these institutes?

## ANSWER

## MINISTER OF STATE FOR SCIENCE AND TECHNOLOGY AND EARTH SCIENCES (SHRI Y.S. CHOWDARY)

- (a) The  Council  of  Scientific  &  Industrial  Research  (CSIR)  has  a  constituent laboratory namely Central Drug Research Institute (CDRI) located at Lucknow, Uttar Pradesh.
- (b) The details of funds sanctioned, allocated and utilized by CSIR - Central Drug Research Institute, Lucknow :

(Rs. in crore)

| Financial Year             |   2014-15 |   2015-16 | 2016-17                      | 2017-18       |
|----------------------------|-----------|-----------|------------------------------|---------------|
| Funds allocated / utilized |   179.789 |   179.161 | 159.161 (under finalization) | Under process |

- (c) Details of the performance of CSIR-CDRI are in Annexure-I.

- (d) CSIR-CDRI is  focused  to  meet  the  aspirations  of  the  Nation.  To  exploit  the wide  ranging  opportunities  and  be  the  flag  bearer,  Institute  is  currently focusing on New  Chemical  Entities, Natural Products, Re-purposing of Approved Drugs, and Biologics to meet the challenges of unmet medical need as  well  as  drug  resistance  in  the  drugs  currently  in  market.  CSIR-CDRI's commitments to National Missions is as follows:
-  Technologies,  Products  and  Service  for  Make  in  India,  Innovate  in  India and Swasthya Bharat Mission
-  Be a catalytic agent to evolve India into Samarth Bharat-Sashakt Bharat
-  Achieve global standards
-  Cater to aspirations of common man and develop technologies beneficial to the poor
-  Bring  confidence  to  society  about  relevance  of  lab  in  terms  of  Social impact
- (e) Details about the collaboration with foreign countries are in Annexure-II.
- (f) The steps taken/being taken by the Government to increase the performance of CSIR-CDRI are in Annexure-III.

## Lok Sabha Unstarred Question No.6381 on 'Central Drug Research Institute'

## The details of the performance of CSIR-CDRI so far:

CSIR-Central Drug Research Institute (CDRI), Lucknow is Seventh in the laboratories that were established  in  India  right  after  its  independence.  Formally  inaugurated  on  17  Feb  1951,  CSIRCDRI is a multidisciplinary research laboratory consisting of scientific personnel of various areas of  biomedical  sciences.  It  has  the  infrastructure  and  expertise  to  develop  a  drug  right  from  the concept  stage  to  the  commercialization.  The  Institute's  latest  techniques  and  services  are employed for developing drugs, diagnostics and vaccines to combat diseases prevalent among mankind in general and Indian population in particular. Since its establishment the Institute  has provided  leadership  on  all  fronts  of  drug  R&D,  namely,  development  of  new  molecules,  novel products, cost-effective indigenous process know how for Institute's candidate drugs and generic drugs/drug intermediates, quality research manpower and trainings in use of sophisticated tools and  techniques  in  drug  research.  Besides,  the  Institute  has  played  a  critical  role  in  putting  the country on the international scene in drug R&D by advancing the knowledge frontier. With a newly set  up  state  of  the  art  drug  research  laboratory,  Institute  is  poised  for  a  huge  leap  in  the biomedical  research  landscape  in  the  country  with  international  relevance.  Highlights  of  CSIRCDRI accomplishments are as below:

-  13 New Drugs,
-  >85 Process Technologies,
-  211 patents in force across the globe,
-  135 patents in force in India,
-  >1500 Ph.D.'s,
-  >2000 Sponsored Trainings
-  >5000 Post Graduate Trainings,
-  >10000 Research Publications,
-  The CSIR-CDRI products that have made a real impact in healthcare include Centchroman, a non-steroidal oral contraceptive for women, licensed to HLL Lifecare Ltd., Thiruvananthapuram  (marketing  it  as  Saheli);  in  the  year  2016,  Centchroman  has  been included  in  the  National  Family  Planning  Program  and  is  being  distributed  freely  with  a brand name Chhaya.
-  Arteether, a fast acting blood schizontocide, licensed to Mumbai based Themis Medicare is being marketed as E-Mal. This drug has been part of the National Malaria Program.
-  Successful Track Record of New Drug Discovery and Development by CSIR-CDRI:

|    | Drug/Product                                      | Use                 | Licensee & year of license                                                          |
|----|---------------------------------------------------|---------------------|-------------------------------------------------------------------------------------|
|  1 | α β - Arteether                                   | Antimalarial        | Themis Medicare Ltd., Mumbai (1997)                                                 |
|  2 | Centchroman                                       | Contraceptive & DUB | HLL Lifecare Ltd., Thiruvananthapuram (1990) Torrent Pharma. Ltd., Ahmedabad (1991) |
|  3 | Bacosides Enriched Standardized Extract of Bacopa | Memory improvement  | Lumen Marketing Co. Chennai (2002)                                                  |
|  4 | Standardized Extract of Dalbergia sissoo          | Fracture Healing    | Pharmanza Herbal Pvt. Ltd., Gujarat (2015)                                          |

|   5 | Centimizone       | Anti-thyroid                | Unichem Lab. Ltd., Mumbai (1972)                                     |
|-----|-------------------|-----------------------------|----------------------------------------------------------------------|
|   6 | Elubaquin         | Anti-relapse anti- malarial | Nicholas Piramal India Ltd., Mumbai (1999)                           |
|   7 | Centpropazine     | Antidepressant              | Merind Ltd., Mumbai (1996)                                           |
|   8 | Chandonium Iodide | Neuromuscular blocker       | Ranbaxy Labs Ltd., New Delhi (1987) Cipla Ltd., Mumbai (1995)        |
|   9 | Consap            | Spermicidal cream           | HLL Lifecare Ltd., Thiruvananthapuram (2004)                         |
|  10 | Centbutindole     | Neuroleptic                 | Chemosyn Pvt. Ltd., Mumbai (1987) Merind Ltd., Mumbai (1997)         |
|  11 | Centbucridine     | Local anaesthetic           | Themis Chemical Ltd., Mumbai (1987)                                  |
|  12 | Gugulipid         | Hypolipidemic               | Cipla Ltd., Mumbai (1987) Nicholas Piramal India Ltd., Mumbai (2000) |
|  13 | Isaptent          | Cervical dilatation         | Unichem Lab. Ltd., Mumbai (1972)                                     |

-  Important Process Development and Technology Transfer:
-  So  far,  CSIR-CDRI  has  licensed  more  than  80  process  technologies  to  the  Industries,  leading  to affordability and accessibility of life saving drugs to the Indian population.
-  Distinguished Recognitions and Awards received by CSIR-CDRI and Scientists:

| Generics                  | Therapeutic Use       | Licensee & year of license                                                |
|---------------------------|-----------------------|---------------------------------------------------------------------------|
| Artemether                | Antimalarial drug     | IPCA Labs (1995)                                                          |
| Acyclovir                 | Antiviral drug        | Ranbaxy (1996)                                                            |
| Sumatriptan succinate     | 5-HT1 agonist         | CIPLA (1993)                                                              |
| Primaquine diphosphate    | Antimalarial          | Nicholas Piramal and IDL (1994)                                           |
| Mefloquine                | Antimalarial          | Wockhardt (1997)                                                          |
| Paracetamol               | Analgesic             | Duphar-Interfran (1973); & 10 other companies                             |
| L-Ephedrine hydrochloride | Anti-nasal congestion | Unichem Laboratories Ltd, (1976);BVM Pharma Ltd, 2013 & 6 Other companies |
| Indomethacin              | Anti-inflammatory     | Kembiotic (1965); IDPL (1976)                                             |
| Ibuprofen                 | Anti-inflammatory     | Astra IDL Limited (1984)                                                  |
| Clofazimine               | Antibacterial         | IDL Chemicals LTD (1979)                                                  |
| Sulphamethoxazole         | Antibacterial agent   | Dolphin Laboratories Pvt Ltd, Kolkata (1977)                              |
| Bivalirudin               | Thrombin inhibitor    | Biocon Ltd. (2010)                                                        |

| Title                                         |   Numbers |
|-----------------------------------------------|-----------|
| Padma Shri                                    |         4 |
| Shanti Swarup Bhatnagar Prize                 |         7 |
| CSIR Technology Award for Innovation:         |         3 |
| JC Bose National Fellowship                   |         3 |
| Fellow of Indian Academy of Sciences          |        10 |
| Fellow of Indian National Academy of Sciences |        23 |
| Fellow of National Academy of Sciences, India |        30 |
| CSIR Young Scientist Awards                   |         9 |
| INSA Medal for Young Scientists               |        11 |

## Annexure-II

## Lok Sabha Unstarred Question No.6381 on 'Central Drug Research Institute' Collaboration with foreign countries

CSIR-CDRI is collaborating with many international agencies since inception towards achieving its mandate. Some of the collaborations in the recent past include:

| Country       | Collaborating Research Institute                                                                                    | Research Activity                                                                                                                                                                                                                                                                                                  | Year Collaboration and Duration Collaboration   |
|---------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| USA           | Advance Research Products, LLC, 608, 21 st Avenue, Paterson, NJ 07513, USA                                          | In vitro Screening of ARP compounds                                                                                                                                                                                                                                                                                | 2016-18                                         |
| USA           | Pennsylvania State University, University Park, USA                                                                 | To investigate whether Lipocalin 2 (in mice) NGAL9 (in human) is a part of DNA decoration along with MPO, elastase etc in neutrophil extracellular traps (NETs)                                                                                                                                                    | 2016-18                                         |
| Brazil        | Federal University of Goiás, Brazil                                                                                 | Deciphering the roles of secreted proteases in host Mycobacterium tuberculosis interaction: Implications for novel drug discovery and vaccine development                                                                                                                                                          | 2016-20                                         |
| France        | Laboratoire de Chimie de Coordination du CNRS, France                                                               | Original biocompatible phosphorus dendrimers as a new strategy to tackle pulmonary tuberculosis.                                                                                                                                                                                                                   | 2015-18                                         |
| Spain         | IRB, Barcelona, Spain and CSIR- CDRI Lucknow                                                                        | Collaboration for understanding organellar translation initiation and stop codon recognition as well as design and evaluation of specific inhibitors                                                                                                                                                               | 2012 - 2015                                     |
| USA           | Kemxtree LLC 1370 Hamilton Street Somerset, NJ 08873                                                                | Discovery and Development of Novel Bone Anabolic agents for accelerated fracture healing (Tripartite)                                                                                                                                                                                                              | 2014                                            |
| JAPAN         | University of Tokyo Toho University School of Medicine                                                              | This was an exploratory project on the circadian modifications in cancer progression 2011 Sept-2014 Sept that investigated the role of circadian proteins involved in cancer pathogenesis.                                                                                                                         | 2011 - 2014                                     |
| Germany       | Institute of Pharmacy, Freie University of Berlin, Germany                                                          | PK -PD modeling using NONMEM for drug development                                                                                                                                                                                                                                                                  | 2013                                            |
| USA           | Tufts Medical Centre, Bostan, MA                                                                                    | Screening of a series of 4-amino quinoline derivatives for identifying more potent and/or functionally altered ligands                                                                                                                                                                                             | 2013                                            |
| UK            | The University of Cambridge of the Old Schools, University of Cambridge                                             | To investigate the ability of the specified CSIR-CDRI compounds to inhibit the interaction of human platelets with the collagen receptor GPVI                                                                                                                                                                      | 2013                                            |
| Spain Germany | Biologia Molecular (CBMSO) Ministry of Science and Innovation, Spain Centro de Spain Goethe University BMBF Germany | To identify nitroxidative stress -related vascular and inflammatory damage present in diabetic models                                                                                                                                                                                                              | 2011 - 2013                                     |
| EU            | 7 institutes from India, Europe and Australia                                                                       | This was a large collaborative project completed in 2013 that investigated translation mechanisms and their inhibition in the malaria parasite. An international team of researchers with complementary expertise (including Dr. Saman Habib from CSIR-CDRI) worked to decipher organellar translation mechanisms. | 2009 - 2012                                     |
| Geneva        | DNDi, Geneva                                                                                                        | Exchange of expertise and facilities                                                                                                                                                                                                                                                                               | 2008-2012                                       |
| France        | European Synchrotron Radiation Facility (ESRF), Grenoble France,                                                    | Essential for protein crystallography studies                                                                                                                                                                                                                                                                      | 2007 onwards                                    |

## Lok Sabha Unstarred Question No.6381 on 'Central Drug Research Institute'

## The steps taken/being taken by the Government to increase the performance of these institutes

CSIR-CDRI  is  currently  involved  in  multifarious  activities  including  new  Drug  development, Technologies, New knowledge and Intellectual space generation, High quality Human Resource development, Societal activities and also play a role in policy matters at various levels. The major mandate of the Institute is new drug discovery and development for unmet medical needs and the thrust areas of research are:

-  Malaria & other Parasitic Diseases (Malaria, Filariasis, Leishmaniasis)
-  Reproductive Health Research, Diabetes & Energy Metabolism (Anti-fertility, Osteoporosis, Diabetes, Breast Cancer)
-  Tuberculosis and Microbial Infections
-  CVS, CNS and Related disorders (Thrombosis, Dyslipidaemia, Obesity, Inflammation, Dementia, Hypertension)
-  Cancer and Related Areas
-  Safety & Clinical Development

CSIR-CDRI  is  equipped  with  necessary  facilities  for  drug  research  under  one  roof  i.e.  from synthesis, screening, development studies, process up-scaling to clinical studies. To remain at par with international excellence in the domain of activity, Institute facilities are persistently upgraded to  benefit  its  ongoing  drug  discovery  and  development  programs  as  well  as  open  for  external users including other Government Institutes, Academic Centres and Industries.

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