title: Development of botanical principles for clinical use in cancer: where are we lacking?
abstract: Development of drugs from plant sources (botanicals) for the treatment of cancer has not been successful in India, despite a plethora of medicinal plants and an equal number of experiments demonstrating anti-cancer activity of plant principles in vitro. There are several pitfalls in our approach to botanical drug development. Foremost is the lack of industry-academia collaborations in this field. Research goals in Indian academic institutions are generally short-term and mostly aimed at fulfilling the minimum requirements of a doctoral/MD or MPharm thesis. Secondly, quality assurance of herbal formulations is difficult to achieve and good manufacturing practices are expensive to implement. This could introduce bias during the biological evaluation of botanicals. A systematic approach covering a wide range of investigations including but not limited to mechanistic studies, potential herb-drug interactions, pharmacokinetics and bioavailability could help in the optimization of herbal formulations in the preclinical stage of development before they can be considered for clinical trials. Government initiatives such as Ayurveda, Unani, Siddha and Homeopathic have encouraged research in these areas, but are insufficient to promote focused and aggressive evaluation of potential herbs. Particular emphasis should be given to clinical pharmacokinetics, drug interactions and clinical trials in specific cancers for the evaluation of dosage, safety, efficacy and concomitant use with chemotherapy. Only such policies can result in meaningful evaluation of botanicals for cancer therapy.
authors.affiliation: Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Kharghar, Navi Mumbai, India. drradhikapoojari@gmail.com
authors.forename: R J
authors.initials: RJ
authors.lastname: Poojari
authors.forename: A G
authors.initials: AG
authors.lastname: Patil
authors.forename: V S
authors.initials: VS
authors.lastname: Gota
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D055808:Drug Discovery / Q000639:trends; D004345:Drug Industry; D006801:Humans; D007194:India; D009369:Neoplasms / Q000188:drug therapy*; D004364:Pharmaceutical Preparations; D008517:Phytotherapy / Q000379:methods* / Q000639:trends; D028321:Plant Preparations / Q000737:chemistry / Q000627:therapeutic use*; D010946:Plants, Medicinal / Q000737:chemistry*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D004364:Pharmaceutical Preparations; D028321:Plant Preparations