Performance Report - Central Drug Research Institute

Performance ReportPROGRESS IN THE DEVELOPMENT OF CANDIDATE DRUGS AND NEW LEADS2.1 Candidate Drugs under Advance Stages of DevelopmentDiseases /DisordersMalariaDiabetes &DyslipidemiaOsteoporosisCandidate Drugs Clinical Status Licensees &Collaborators97-78 Antimalarial Phase-I clinical pharmacokinetic studies have been completed in 16 IPCA Lab., Mumbai 2004healthy male volunteers at PGIMER, Chandigarh in collaborationwith IPCA Labs, Mumbai. Samples analyzed & report sent to IPCA99-411 Antimalarial Pre-clinical data is under compilation for IND submission IPCA Lab., Mumbai 2007CDR134D123 Detailed quality monograph on the epicarp of the plant Xylocarpus TVC Sky Shop Ltd., MumbaiAnti-hyperglycemic granatum as per the specifications of DGCCRAS has been 2008submitted. The matter is awaiting DGCCRAS clearance forinclusion in the Extra Ayurvedic PharmacopiaCDR134F194Anti-hyperglycemic99-373Anti-osteogenic1020F147Anti-osteoporoticThe preparations for the drug formulation to be used in Phase-ISingle Dose and Multiple Dose Clinical Trial studies from a GMPcertified company is in progress and the clinical trial wouldcommence soonPhase I clinical trial is to be initiatedProduct is being further developed as nutraceutical and dietarysupplement for optimum bone health. Submitted to NMITLI forfunding of clinical trialUnder negotiationNatural Remedies,Bangalore 20102.2 Potential New LeadsDiseases /DisordersLead & Efficacy Current Status Licensees &CollaboratorsOsteoporosisCDR914K058OsteogenicSynthetic process developed by CSIR-IICT. Licensed to Kemxtree,USA for further development and commercializationKemxtree, USA2012S007-1500Rapid fracturehealingCDR4744F004Osteoprotective &bone anabolicCancer S007-1235Anti-leukemicCompound found safe in single dose toxicity study by oral route inrat and mice and by IM route in rat. Two year stability studycompletedStandardized fraction found to have bone anabolic effect inosteopenic rats; Principal component analysis of bioactive markerscompleted. Further studies are under progressIC 50 in K562, HL-60, U937, Kasumi1, Vero, & NIH3T3 respectively:3.61 µM, 5.99 µM, 6.78 µM, 8.12 µM, >25 µM, > 20 µM. Activity isbetter than Imatinib (first gen) and Dasatinib (2nd gen). Possiblemode of action established. Detailed mechanism, includingidentification of target and in vivo studies are planned furtherUnder negotiationOpen for licensingThrombosisS007-867AntithromboticS002-333AntithromboticCompound found safe in single dose toxicity study by oral route inrat and mice and by IM route in rat; No adverse effect on CVS, CNSand respiratory parametersCompound found safe in single dose toxicity study by oral route inrat; Patent granted. There was no significant effect on CNS, CVSand respiratory system up to 1000 mg/kg, po in rats.Under negotiationDiabetes &DyslipidemiaCDR267F018AntidyslipidemicCompound found safe in 28 day repeat dose toxicity study in RhmonkeyOpen for licensingCDR4655K09AntidyslipidemicEfficacy established as a new class of HMG-CoA reductase and aspotential lipid lowering agentContraception S010-1255Spermicidal &AntitrichomonalTuberculosis S006-830AntituberculosisPotent spermicidal and anti-trichomonal (against bothmetronidazole susceptible and resistant strains) activity establishedwith much higher safety index compared with Nonox-9Efficacy established in vivo in the mouse model of TB. Large scalesynthesis completed. Pilot pharmacokinetic study of S006-830 inmale SD rats completed and compound showed betterbioavailabilityOpen for licensingBeing developed underOSDDiiCSIR-CDRI

Performance ReportPUBLICATIONS350300250236297247321291*2001501005002008 2009 2010 2011 2012Average Impact FactorImpact Factor-wise No. of Publications 2012*3.532.52.372.572.91 2.843.21*IF 1-2: 36(62)IF 5:24(22)IF 4-5: 49(41)21.51IF 2-3: 77(101)IF 3-4: 72(55)0.502008 2009 2010 2011 2012Ph.D. THESIS SUBMITTED*Provisional data as on 31-01-2013, Previous year data is given in bracketAnnual Report 2012-13iii

Performance ReportINTELLECTUAL PROPERTYIndian PatentsForeign Patents1210129121025201920 21189848642265151051210676402008 2009 2010 2011 201202008 2009 2010 2011 2012Provisional Data as on 31/01/2013NEW INTER-AGENCY PROJECTS INITIATED353025201510501226320071223231922562242008 2009 2010 2011 201232982223466312999DBT DST ICMR DRDO Foreign Industry OthersProvisional Data as on 31/01/2013NEW FACILITIES CREATEDSmall Molecule X-Ray Crystallography700 MHz. NMRPerkin Elmer, Spectrum II FTIRivCSIR-CDRI

Performance ReportMANPOWERTotal Staff (621)Designation-wise Number of ScientistsTech. Gr. I:120Admin:126Tech. Gr. II:106Scientist:143Tech. Gr. III:126SeniorPrincipalScientist:31JuniorChief Scientist:Scientist: 422PrincipalScientist:22Scientist:36SeniorScientist:28Area-wise Strength of Scientists Research Fellows and Project Assistants (534)Others:7Bio-Sciences:65Proj Asst.:80RA:4Safety &ClinicalSciences:25TechnicalServices:29ChemicalSciences:24JRF:188SFR:255*Data as on 31-01-2013WE WELCOME NEWLY RECRUITED SCIENTISTSDr. Monika SachdevSr. Scientist, Endocrinology DivisionDr. Susanta KarScientist, Parasitology DivisionDr. Prem Narayan YadavSr. Scientist, Pharmacology DivisionDr. Tejender S. ThakurScientist, MSB DivisionDr. Sidharth ChopraSr. Scientist, Microbiology DivisionAnnual Report 2012-13v

Performance ReportOSDD CHEMISTRY OUTREACH PROGRAM (OSDDChem)(CSIR-CDRI as Coordinating Laboratory)On the occasion of the International Year of Chemistry 2011, CSIR, under the aegis of its OSDD initiative, haslaunched a Chemistry Outreach Program through CSIR-CDRI as the coordinating laboratory. The major objectives of theprogram are:• To create a Chemical Library of diverse small molecules synthesized mainly by the M.Sc. and Ph.D. studentsworking at Universities/ colleges/ institutes across the length and breadth of the country;• To impart practical training to M.Sc. students specializing in organic chemistry towards synthesis and spectroscopiccharacterization of organic compounds;• To set up OSDD Outreach Centres at different CSIR labs including CSIR-CDRI (Lucknow), CSIR-NEIST (Jorhat),CSIR-IICB (Kolkata), CSIR-NIIST (Trivandrum), CSIR-IICT (Hyderabad) and CSIR-IIIM (Jammu) where studentsfrom nearby places can carry out short duration projects;• To investigate the bioactivity of the compounds in antitubercular and antimalarial assays;• To archive the compounds in state of the art storage facility for other biological assays and future usage.Incentives:• An initial amount of Rs. 1 lakh for consumable cost,and Rs. 5 - 10 lakhs for minor equipments cost, ifneeded, will be transferred by cheque/bank transferto the respective institute or laboratory by CSIR-CDRI(no funding to CSIR labs);• Rs 3000/- to be paid for each compound (debitedfrom the consumable grant);Distinct Features:• For the first time, a project like this has beenenvisioned and initiated that will impart training tolarge number of MSc and PhD students, especiallyin organic, medicinal, computational chemistry,pharmacy, etc. in colleges, universities, IITs, IISERsand other academic institutes in the country that willcreate a large knowledge base in the country.For further details, please visit: http://crdd.osdd.net/osddchem or write to Dr. Sanjay Batra at s_batra@cdri.res.in• OSDD OUTREACH CENTRES have been set up inmany CSIR labs. Besides, university departments designated for carrying out this work can train other studentsfrom nearby colleges and universities who do not have any facility.• The compounds generated in these projects are to be submitted to CSIR-CDRI for screening and archiving.Results will be made available to the investigators for publishing papers and OSDD will take the active moleculesforward.Progress made so far:• Program is already becoming popular with the “MSME”s of Indian Universities/Educational Institutions.• More than 50 projects have already been submitted from 31 institutes across the country with nearly 1600 moleculesin the database. The number is increasing slowly, but steadily.viCSIR-CDRI

Performance ReportBUDGET` in LakhHeads 2008-09 2009-10 2010-11 2011-12 2012-13(Anticipated)(A)RecurringPay and Allowances 2913.871 4046.092 3821.022 3926.863 5014.000Contingencies 210.991 256.298 393.437 409.510 700.000HRD 2.881 4.000 4.535 4.00 6.000Maintenance 159.539 178.112 248.190 283.125 540.000Chemical and Consumables 400.076 411.699 601.112 1041.550 1013.950Sub-Total 3687.358 4896.201 5068.296 5665.048 7273.950(B)CapitalWorks and Services/ ElectricalInstallation86.264 66.682 109.370 -1682.478 722.980Apparatus and Equipments/ ComputerEquipments344.112 488.779 1550.000 3466.500 3108.000Office Equipments, Furniture andFittings9.962 4.021 7.031 6.950 17.000Library Books and Journals 207.00 215.000 275.000 240.587 350.000Sub-Total 647.338 774.482 1941.401 2031.559 4197.98Total (A+B) 4334.696 5670.683 7009.697 7696.605 11471.930(C)Special Projects SIP/NWP/IAP/HCP/BSC/CSC1218.38 452.48 1312.323 995.599 2401.489(D) CMM0015 (New CDRI) 3323.150 6669.000 9504.300 3843.710 700.000Grand Total (A+B+C+D) 8876.226 12792.163 17826.32 12535.914 14573.419*Provisional data as on 31-01-2013viiiCSIR-CDRI

Performance ReportEXTERNAL BUDGETARY RESOURCES AND CSIR GRANT` in LakhExternal Cash Flow from Govt AgenciesExternal Cash Flow from Foreign Agencies18001628.95 1577.951500.00*200180.08150012009006001090.021343.551601208077.49118.0049.583004002008-09 2009-10 2010-11 2011-12 2012-1302008-09 2009-10 2010-11 2011-12 2012-13External Cash Flow from IndustriesLab Reserve Fund Generated30.0025.0028.2023.49 23.26300250215.65255.58269.63250.00*20.0020015.0010.00*150111.7310.001005.001.00500.002008-09 2009-10 2010-11 2011-12 2012-1302008-09 2009-10 2010-11 2011-12 2012-13Total External Budgetary Resources # Total Budget (CSIR-Grant) #2500.002000.002052.88 1975.021686.031760.00*20000.0016000.0012792.1617826.3212535.9114573.421500.001280.2412000.008876.261000.008000.00500.004000.000.002008-09 2009-10 2010-11 2011-12 2012-130.002008-09 2009-10 2010-11 2011-12 2012-13#Includes ECF and LRF#Includes Regular Budget and Plan Projects (CMM/SMM/SIP/NWP/IAP/HCP/OLP/MLP)Anticipated for 2012-13*Anticipated for 2012-13Annual Report 2012-13ix

Research Council(April 2010 – March 2013)ChairmanProf. N.K. GangulyFormer Director-General, ICMRDistinguished Biotechnology Fellow & AdvisorTranslational Health Science & TechnologyInstituteC/o National Institute of ImmunologyAruna Asaf Ali MargNew Delhi – 110 067MembersProf. A. SuroliaMolecular Biophysics UnitIndian Institute of ScienceBangalore - 560 012Dr. K. NagarajanCorporate AdvisorHikal Ltd., R & D CentreKalena Agrahara Bannerghatta RoadBangalore – 560 076Dr. Shekhar C. MandeDirectorNational Centre for Cell ScienceGaneshkhindPune - 411 007Prof. K.N. GaneshDirectorIndian Institute of Science Education andResearch900, NCL Innovation ParkDr. Homi Bhabha RoadPune- 411 008Dr. R. NagarajChief ScientistCSIR-Centre for Cellular and Molecular BiologyHyderabad- 500 007Dr. Bhaskar SahaScientistNational Centre for Cell ScienceGaneshkhindPune- 411 007Dr. M.D. NairA-11 Sagarika No. 153 rd Seaward Road, Valmiki NagarChennai - 600 041Agency RepresentativeDr. (Ms.) Deepali MukherjeeChief ECDIndian Council of Medical ResearchPost Box No. 4911, Ansari NagarNew Delhi- 110 029DG NomineeDr. Rajesh S. GokhaleDirectorCSIR-Institute of Genomics and IntegrativeBiologyUniversity Campus, Mall RoadDelhi- 110 007Sister LaboratoryDr. Ram RajsekharanDirectorCSIR-Central Food Technological ResearchInstituteMysore – 570 020Cluster DirectorProf. Siddhartha RoyDirectorCSIR-Indian Institute of Chemical Biology4, Raja SC Mullick Road, JadavpurKolkata- 700 032DirectorDr. Tushar Kanti ChakrabortyDirectorCSIR-Central Drug Research InstituteLucknow – 226 021Permanent InviteeHead or his NomineePlanning & Performance DivisionCouncil of Scientific & Industrial ResearchAnusandhan Bhawan, 2, Rafi Marg, New Delhi - 110 001SecretaryDr. Saman HabibScientistMolecular & Structural Biology DivisionCSIR-Central Drug Research InstituteLucknow – 226 021xCSIR-CDRI

Management Council(January 2012 – December 2013)ChairmanDr. TK ChakrabortyDirectorCSIR-Central Drug Research Institute,Lucknow – 226 021MembersDr. KC GuptaDirectorCSIR-Indian Institute of Toxicological ResearchLucknow - 226 001Dr. Rajendra PrasadChief ScientistBusiness Development DivisionCSIR-Central Drug Research InstituteLucknow - 226 021Dr. PMS ChauhanSenior Principal ScientistMedicinal & Process Chemistry DivisionCSIR-Central Drug Research InstituteLucknow - 226 021Dr. Neena GoyalSenior Principal ScientistBiochemistry DivisionhCSIR-Central Drug Research InstituteLucknow - 226 021Dr. KV SashidharaSenior ScientistMedicinal & Process Chemistry DivisionCSIR-Central Drug Research InstituteLucknow - 226 021Dr. Dipankar KoleyScientistMedicinal & Process Chemistry DivisionCSIR-Central Drug Research InstituteLucknow - 226 021Mr. HM GuniyalPrincipal Technical OfficerSophisticated Analytical Instrument FacilityCSIR-Central Drug Research InstituteLucknow - 226 021Mr. AK DwivediController of Finance & AccountsCSIR-Central Drug Research InstituteLucknow - 226 021Member SecretaryMr. LR AryaController of AdministrationCSIR-Central Drug Research Institute,Lucknow – 226 021Annual Report 2012-13xi

NotesxiiCSIR-CDRI