Drugs & Pharmaceutical Research : Achievements

Significant Achievements

Clinical Trials

A peptide based anti-cancer drug for the treatment of colorectal cancer by Dabur Research Foundation under Phase-II of clinical trial.

Patents - Product Patents:

Six product patent applications based on three projects have been filed:

  • "A new drug for the treatment of cancer" - India, USA, Australia, Canada, Europe, Israel and Japan
  • "Novel peptide analogs for the treatment of cancer" - India
  • "A novel oligospirostanoside from Asparagus racemosus" - India
  • Cyclopentenone derivatives for cancer therapy - India and USA(PCT)
  • Flavopereirine derivatives for cancer therapy - PCT
  • Hydroanthracene based compounds as anticancer agents (PCT)

Process Patents:

Twelve process patent applications based on four projects have been filed .

  • "Novel process for the preparation of 'Asavas' and 'Arishtas' range of Ayurvedic formulations" - India
  • "A process for the isolation of an antioxidant and free radical scavenging fraction of Terminalia chebula" - India
  • "A standardised immuno- modulatory fraction of plant origin" - India
  • "A stereo specific process for the preparation of substituted piperidines" - India
  • "Immunoside, an oligospiro-stanoside, potent immunomodulatory agent from Asparagus racemosus" - India
  • "A process for the preparation of novel 3-(3-aryl-isoxazol-5-yl)-3-hydroxy-2-methylene-propionic acid derivatives"-India.
  • "A process for the preparation novel combinatorial library of-3-substituted amino-3-glycosylated propanoate derivatives useful as antiparasitic, antifungal and antibacterial agents"-India.
  • "A process for the preparation novel combinatorial library of 3-substituted amino-3-glycosylated propanamide derivatives useful as antifungal and antibacterial agents"-India.
  • "A process for the preparation of novel combinatorial library of 3 and 30-substituted lup-20-(29)-ene useful as antimalarial agents"-India.
  • "A process for the preparation of 2-aryl-4-hydroxy-cyclopent-2-en-1-one"-India
  • A process for the preparation of 2,3-diaryl-4-(tert-butyldimethylsilyloxy) cyclopent-2-en-1-one"-India
  • A process for the preparation of 5-methylene-4-benzyl(substituted)-2(5H)-Furanone"-India

National Facilities Set Up

  • Identification of Immunomodulating potential of products and or extracts of natural origin - IICB, Kolkata.
  • Strengthening of Pharmacological testing facilities - CDRI, Lucknow
  • Facility for the characterisation of crystals of biological macromolecules of medicinal and industrial importance - IISc., Bangalore
  • Combinatorial Chemistry-cum-Medium Throughput screening: central facility - CDRI, Lucknow
  • National facility on Transgenic and Knock-out mice - Centre for Cellular and Molecular Biology (CCMB), Hyderabad
  • National facility on Bio-availability-NIPER, Chandigarh
  • National facility on Pharmacokinetic and metabolic Studies, CDRI, Lucknow
  • National facility on Genomics Research for Drug Discovery, IGIB, Delhi
  • National facility on Pharmainformatics at NIPER, Chandigarh.

Completed Collaborative Projects

(A) New Chemical Entities:

  • New drug studies for development of peptides based anti-cancer agent
  • Synthesis and biological evaluation of Camptothecin and Podophyllotoxin analogues
  • Synthesis and screening of newer analogues of Quinolone Carboxylic acid as anti-infective agents with special emphasis on activity against multi drug resistant bacterial, Mycobacterial and fungal pathogens
  • Sugar and heterocycle modified Nucleosides : Section A - Synthesis of New Potential Antivirals. Section B - Development of cost effective processes for antiviral drugs
  • Novel hypocholesterolemic agents : synthesis and biological evaluation of squalene epoxidase inhibitors
  • Discovery of Novel peptidomimetics as endothelin receptor antagonists: de novo synthesis using b-Dehydro and b-Amino Acids and crystallographic studies utilising cloned receptor.
  • Synthesis and screening of new Antimycotic agents.
  • Synthesis of structurally unique anti-Cancer agents and their biological evaluation
  • Rational design and synthesis of novel antibacterial agents.
  • Novel monosaccharide and disaccharide derivatives as anti-inflammatory and anti-proliferative agents.
  • Synthesis of selective Cyclooxygenase-2 inhibitors and novel symbiotic approach to anti-inflammatory and immunomodulatory therapy.
  • Lead optimisation and development of new gastric proton pump inhibitor.
  • Rational design, synthesis and screening of new antimicrobial macrolides
  • New anti-cancer compounds : design, synthesis, screening and optimisation through QSAR.
  • Design synthesis and bioactivity determination of antagonist analogues and mimetics of vasoactive intestinal peptide (VIP) for cancer therapy
  • Design, synthesis and biological evaluation of new antitubercular compounds.
  • Structure based drug design, synthesis, SAR studies and screening of novel anti-tubercular and anti-bacterial compounds
  • Identification and development of novel anti-cancer agents.
  • Synthesis of selective b-3 adrenergic receptor as a novel therapy for obesity.

B) Vaccines:

  • Development of Preventive and Therapeutic third Generation Recombinant Hepatitis - B Vaccine
  • Development of recombinant vaccine against rabies.

C) Assay Systems:

  • Development of methods for purification and characterisation of Cox I and Cox II
  • Rational Development of Anti-Tuberculosis drugs - Mycobacterium tuberculosis DNA Gyrase inhibitors

D) Drug Delivery System :

  • Development of transmucosal drug delivery system (TMDDS) containing an antiulcer drug.

e) Herbal Drugs (Indian System of Medicine):

  • Development of Herbal drugs as Adaptogens / Immunomodulators
  • Process validation and biological evaluation of Asavas and Arishtas with special reference to inoculum bearing herbs
  • Bioefficacy and analytical evaluation of Herbal Active Molecules. Development of standardised single plant formulations for commonly encountered diseases associated with high morbidity and mortality viz. Diarrhoea, pancreatitis, gastritis and Ischaemic heart disease.
  • Development of standardized metallic and herbo-mineral formulations based on toxicological pharmacological and process chemistry investigations

On-Going Collaborative Projects:

(a) Herbal Drugs - Indian System of Medicine (On-Going):

  • Process and product standardisation of classical Ayurvedic drugs with special reference to Rheumatism.
  • Screening of cancers manifesting altered histone acetyltransferases (HATs) and deacetylases (HDACs) function and search for inhibitors of these enzymes in natural products as therapeutic agents.
  • Study of the identified plant based immunostimulators as potential adjuvants for vaccines
  • Scientific evaluation of safety and efficacy profile of Herbal Siddha formulation in the management of rheumatoid arthritis
  • Efficacy and safety evaluation of Siddha medicine HIVS-2004 for HIV/AIDS
  • Development and Standardisation of therapeutic herbal formulations for the management of alopecia and skin disorder
  • Development of Herbomineral (Ayurvedic) and Plant based disease oriented immunomodulator formulation
  • Scientific evaluation of safety and efficacy profile of Siddha formulation in the management of leucoderma
  • Standarisation and modernization of Ayurvedic Herbal formulations using modern techniques
  • Development and standardization of herbal anti-malarial drug
  • Development of drugs for the medical therapy of Glaucoma using natural products
  • Clinical and experimental evaluation of Reno Protective Effect of Maha Nimb Rhubarb and Herbal Compound (Ayurvedic)
  • Quality assurance and validation of some Ayurvedic formulations for Lifestyle related and gynaecological disorders

(b) New Chemical Entities (On-Going):

  • Design synthesis and testing of new chemical entities as potential anti-fungal agents
  • Computer aided design synthesis and biological evaluation of novel phosphodiesterase-4 inhibitors
  • Identification and optimization of Lead Molecules for Development as anticancer agents
  • Lead Optimisation and development of new orally active anti-malarial peroxides

( c) Assay Systems (On-Going):

  • Molecular bypass : Development of vascular endothelial growth factor (VEGF) for therapeutic myocardial angiogenesis.
  • Development of indigenous diagnostics ELISA kits based on capsid antigen capture assay for HIV-1 and HIV-2.
  • Novel poly-lactide-co-glycolide (PLG) based oral sustained release drug delivery system for treatment of tuberculosis
  • Enhancement of Benzaldehyde Biotransformation
  • Development of controlled/sustained release formulations for some newer cardiovascular and anti-inflammatory drugs
  • Cardoguard tablet delineation of molecular mechanism of action and its efficacy in the regression of ventricular hypertrophy
  • Development of poly-lactide-co-glycolide (PLG) for nano-encapsulation of tuberculosis drug for sustained release drug delivery system.
  • Development of PLG [Poly(dl-lactide-co-glycolide) for nanoencapsulation of tuberculosis drug for sustained release drug delivery system
  • Poly lactide-co-glycolide nanoparticle based oral sustained release drug delivery system for treatment of MDR tuberculosis
  • Evaluation of the toxicity and anti-leishmanial efficacy of Liposomal Amphotericin B (KALSOME TM) in mouse model

(d) Veterinary Drugs

  • Development of novel herbal ecto-parasiticidal product

(e) Others (On-Going):

  • Study of the identified plant based immunostimulators as potential adjuvants for vaccines : Development of a novel immunoadjuvant.
  • Development of Botanical immunomodulators as adjuvants for improving vaccine efficacy

Industry/Institutional Alliances:

Under this programme, so far 50 industry-institutional alliances have taken place among the following:

Industries

  • SPIC Pharma, SPIC Centre , 97, Mount Road, Guindy Campus, Chennai - 600 032
  • Dr. Reddy's Foundation, 7-1-27, Ameerpet, Miyapur, Hyderabad - 500 016
  • Ranbaxy Laboratories Ltd., Sector 8, Udyog Vihar, Gurgaon - 122 001
  • Dabur Research Foundation, 22, site-IV, Sahibabad, Ghaziabad - 202 010
  • Zandu Pharmaceuticals Works Ltd., Gokhale Road, South Dadar, Mumbai - 400 025
  • Recon Ltd.,Kalana Agrahara Village, Bannerghatta Road, Bangalore - 560 076
  • Bharat Biotech International Ltd., 726, Road .3, Banjara Hills, Hyderabad - 500 034.
  • Cadila Healthcare Ltd., Surkhej Bawla Highway, Ahmedabad - 382 210
  • Indian Herbs Research and Supply Co.Ltd., Sharda Nagar, Saharanpur-247001
  • Arya Vaidya Sala, Kottakkal - 676 503 (Kerala)
  • Cadila Pharmaceuticals Ltd., B.D.Patel House, Naranpura, Ahmedabad - 380 014
  • Glenmark Pharmaceuticals Ltd., B/2 Mahalaxmi Chambers, Mumbai - 400 026
  • Alembic Ltd., Alembic road, Vadodara - 390 003
  • Lupin Laboratories Ltd., 159-CST Road, Kalina Santacruz(E) Mumbai - 400 098
  • Dey's Medical Stores Mfg. Ltd., 6/D, Lindsay Street, Kolkata - 700 017
  • Life Pharmaceuticals Pvt. Ltd, 3/2B, Orient Row, Kolkata - 700 017
  • Herbochem Remedies India (P) Ltd, Narendrapur, 10, Musalman Para Road, Distt. 24, Parganas (South), West Bengal - 743508
  • FDC Ltd., Mumbai
  • Lifecare Innovations Pvt. Ltd., Gurgaon
  • Vedic Drugs Pvt. Ltd., Bangalore
  • Indian Medicines Pharmaceuticals Corporation Ltd., Mohan, Uttaranchal
  • Nagarjuna Herbal Concentrates Ltd., Idukki, Kerala
  • Shree Dhootapapeshwar Ltd., Panvel, Maharashtra
  • Marico Industries Ltd., Mumbai
  • Citadel Fine Pharmaceuticals Ltd., Chennai
  • Sami Labs Ltd., Bangalore
  • Natural Remedies Pvt. Ltd., Bangalore
  • Petlad Mahal Arogya Mandal Pharmacy, Nadiad, Gujarat
  • Ipca Laboratories Ltd., Mumbai
  • Promed Exports Pvt. Ltd., New Delhi
  • Emmellen Biotech Pharmaceuticals Ltd., Mumbai
  • Serum Institute of India Ltd., Pune
  • Surya Pharmaceuticals Ltd., Varanasi

Institutions :

  • Indian Institute of Chemical Technology (IICT), Uppal Road, Hyderabad - 500 007
  • Central Drug Research Institute (CDRI), Chattar Manzil Palace, Lucknow - 226 001
  • Centre for Biochemical Technology (CBT), University Campus, Delhi -110 007
  • Regional Research Laboratory(RRL), Canal Road, Jammu - 180 001
  • Regional Research Laboratory(RRL), Indl. Estate, Thiruvananthapuram - 695 019
  • National Chemical laboratory(NCL), Pashan road, Pune - 411 008
  • Indian Institute of Chemical Biology(IICB), Jadavpur, Calcutta - 700 032
  • Centre for Cellular & Molecular biology(CCMB), Uppal Road, Hyderabad - 500 007
  • Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Jakkur, Bangalore - 560 064.
  • Central Institute for Research on Goats (CIRG), Mathura
  • Central Leather Research Institute (CLRI), Chennai

Academia:

  • Indian Institute of Science(IISc.), Bangalore - 560 012
  • University of Hyderabad, Hyderabad - 500 046
  • University Department of Chemical Technology(UDCT), Mumbai - 400 019
  • All India Institute of Medical Sciences(AIIMS), New Delhi - 110 029
  • Tamil Nadu Veterinary & Animal Sc. University (TANUVAS), Chennai - 600 051
  • Delhi University, South Campus, New Delhi - 110 021
  • Indian Institute of Technology, Kanpur - 208 016
  • Indian Institute of Technology, Mumbai
  • Seth G.S. Medical College & KEM Hospital, Parel, Mumbai - 400 012
  • Saurashtra University, Rajkot - 360005
  • Post Graduate Institute of Medical Education and Research (PGI), Chandigarh
  • National Institute for Pharmaceutical Education and Research (NIPER), Chandigarh
  • Sastra Deemed University, Thanjavur (TN)
  • JSS College of Pharmacy, Ootacamund (TN)
  • SP Mandali's Ramnarain Ruia College, Mumbai
  • BYL Nair Hospital and Medical College, Mumbai
  • Sree Chitra Tirunal Institute for Medical Science & Technology, Thiruvananthapuram
  • Sardar Patel University, Vallabh Vidyanagar, Gujarat
  • Veer Narmad South Gujarat University, Surat, Gujarat
  • Delhi Institute of Pharmaceutical Sciences and Research (DIPSAR), New Delhi
  • University of Pune, Pune
  • Banaras Hindu University, Varanasi