Scientific medical care not only improves people's functional ability and quality of life but also enhances life expectancy. Medicine, often described as the science and art of healing, comprises a wide variety of health-care practices to prevent and cure diseases. Drugs and medicines have a crucial role in therapy in any practical medical system. Better forms of treatment may require improved or new forms of drugs. Often, new diseases emerge, demanding drugs to be discovered through research.
Even at the global level, only a few institutions focus on drug research. In India, one such institution is the Central Drug Research Institute (CDRI), Lucknow – 226 001; website: www.cdriindia.org.
The then Prime Minister, Jawaharlal Nehru, inaugurated the pioneer research organisation in the field of biomedical research on February 17, 1951. The institute has the capability to develop a drug from the conceptual to the market stages. Latest techniques and methodologies are employed for developing drugs, diagnostics, and vaccines through a multidisciplinary approach. Some of the activities of the institute are:
Development of new drugs and diagnostics
Discovery of new drugs in disease areas of national relevance
Cellular and molecular studies to understand diseases
Development of contraceptive agents and devices
Systematic evaluation of medicinal properties of natural products
Development of technology for drugs, intermediates, and biologicals
Consultancy and development of technical manpower
The institute strives to continue as one of the major centres for drug R&D and emerge as a world-class research institute.
In drug discovery and development, it focusses on cancer biology and related areas, with focus on breast, cervical, oral, prostate, and blood cancers. The objectives are:
Creation of appropriate platform for interdisciplinary collaborative research
Creation of knowledge base in cancer biology
Lead identification and optimisation to obtain drug-like molecules
To tackle cardiovascular, central nervous system and other disorders, the institute is involved in:
Design, synthesis and development of new drugs to treat hypertension, dyslipidemia, atherosclerosis, stroke, and thrombosis; dementia and stress; and gastric ulcers and inflammation. Under this project several drugs and formulations have been developed and licensed to various pharmaceutical companies.
Fight against parasites
The institute focusses on tackling parasitic diseases such as malaria, leishmaniasis, and filaria. More than four billion people in over a hundred countries are at risk from these diseases. To meet this major challenge, the institute addresses issues pertaining to the design and development of novel drug molecules. It further focusses on optimisation and pre-clinical development of lead molecules and combination therapy regimens. Studies are conducted on identification and characterisation of novel drug targets, mechanisms of drug action and drug resistance, parasite biology and host-parasite interaction, immunoprophylaxis, and immunodiagnosis. These involve:
Synthesis of compounds for anti-parasitic activity
Bio-evaluation against internationally accepted in vitro and in vivo experimental models
Leishmania in vitro screening assays
Filaria — Brugia malayi motility and MTT reduction in vitro
Identification and characterisation of novel drug targets
Molecular and cell biology of parasites
Identification and validation of parasite vaccine target molecules and their prophylactic potential against leishmania and filaria
In reproductive health research, the institute focusses on developing female and male contraceptives and spermicides with anti-STI (sexually transmitted infection) properties.
The institute is involved in finding agents for the management of osteoporosis, diabetes and energy metabolism, and tuberculosis and microbial infection.
Its microbial infection research focusses on tuberculosis and fungal and viral infections. Though curable, tuberculosis continues to kill millions of people worldwide each year. The lengthy course of the drugs-in-combination means many patients stop taking them midway. This causes the emergence of multi-drug-resistant (MDR) TB. Simplifying and shortening the treatment for drug-sensitive tuberculosis and providing new treatments for MDR-TB constitute two major goals in the development of novel drugs for tuberculosis. The institute addresses this problem.
Eight ‘candidate drugs,' including those for diabetes and malaria, are under advanced stages of development at the institute.
Safety, dosage form design, and pre-clinical and clinical development of ‘candidate drugs' are taken up by the divisions of pharmaceutics, pharmacokinetics, regulatory toxicology, regulatory pharmacology, and clinical and experimental medicine.
Investigational new drug applications have to be prepared according to the guidelines of Schedule Y of the Indian Drugs and Cosmetics Act. A group is involved in the generation of a large amount of data in relation to methods of manufacture and resultant analytical specifications, storage stability, and formulation and delivery systems.
Pharmacokinetics, pharmacological mechanisms of action, efficacy and safety in animal models, including rodents and non-human primates, and the elucidation of mechanisms responsible for different pharmacological and toxicological effects are other aspects to be considered.
Regulatory pharmacological studies constitute an essential part of pre-clinical investigations. They explore and find out whether a substance has the potential pharmacological activity in organ systems other than the one targeted for therapeutic purposes. Any candidate drug to be developed should be devoid of any significant effect on other systems. The regulatory pharmacology programme consists of test systems in experimental animals, usually mice and rats, in the following areas:
The regulatory toxicology group is involved in profiling of candidate drugs according to the Schedule Y guidelines. Systemic toxicology, reproductive toxicology, genetic toxicity, immuno-toxicity, local toxicity, and carcinogenicity will be done for new chemical entities.
The clinical group conducts clinical trials of candidate drugs. The pharmaco-kinetic study group develops validated bio-analytical assay procedures for quantification of new chemical entities. There is a pharmaceutics group which is involved in analytical method development, quality assurance, and pre-formulation studies on candidate drugs. It also develops drug delivery systems.
The institute offers Ph.D. programmes in various areas of life sciences, biotechnology, and chemical and pharmaceutical sciences, directed towards new drug development.