Pharmaceutical industry in India traditionally relies on synthesis of chemical compounds for drug discovery research. Modern drug research is driven by biology - molecular genetics, genomics and bioinformatics. Human healthcare through drug discovery is one of the main applications of the biotechnology industry, and hence many pharma companies are also active players in the biotech industry.
With the advent of large-scale industrial processes to produce high quality drugs and dosage forms, the pharmacist's primary role shifted in the middle of this century from that of accurate compounding to one of distribution for the pharmaceutical industry. During this time the scientific basis of industrial drug discovery and development inspired parallel changes in pharmacy education, from empirical and descriptive knowledge focusing on the procurement, preparation, and evaluation of pharmaceuticals, to knowledge organized around scientific paradigms.
Research and development (R&D) is the lifeblood of pharmaceutical industry. Pharmaceutical companies have discovered 1,400 new chemical entities in the last three decades. Indeed pharmaceutical business is more R&D-intensive than other industries.
India has now emerged as a favoured destination for basic as well as applied scientific research. The country offers advantages that few others can match like abundant availability of scientific talent, skilled labour, world-class academic institutions dedicated to science and technology, entrepreneurial culture and competitive costs.
The focus is to meet future challenges of globalization and patent regime by concentrating more on research and development activities. The investment in R&D will accelerate move towards development of new chemical entities, new drugs delivery system and generics products. To overcome the stiff competition in the international as well as domestic market, Indian companies have started investing in basic research.
Recent advances in understanding disease development and in technology have markedly facilitated the process of drug discovery. The discovery of new drugs to treat diseases has become a multidisciplinary undertaking, involving biochemists, physiologists, pharmacologists, medicinal chemists, computer analysts, clinicians, and others. Individuals, preparing for a career in drug discovery might consider becoming familiar with various areas involved in the drug discovery process. The drug discovery process is responsible not only for the introduction of many new drugs to the market place but also for improvements in the therapy of many diseases. These include drugs to treat cardiac disease, stroke, bronchial asthma, rheumatoid arthritis, diabetes, bacterial and viral infections, and neurological and psychiatric diseases. Traditionally, the discovery of new drugs has been based on observations of a useful biological effect produced by a natural product, usually obtained from a plant or microorganism, or a synthetic chemical compound. If the biological effect of a chemical antagonized the symptoms of a disease and the adverse effects were minimal, it would be considered as a potential drug to treat disease.
Pharmacist fulfils his societal role by utilizing and organizing the scientific knowledge to create potential drug molecules and their formulations. The study of pharmacy is mainly concerned with the action of drugs on biological systems and their applications for human drug therapy. The programme prepares graduates for the contemporary role of the pharmacist in society - ensuring that patients optimize medication usage. Initial courses on chemical, physical, and biological studies lead to professional specialties in later years.
A pharmacy student interested in drug discovery, must be well-grounded in science-based courses. This grounding would include not only the standard science courses, such as physics, general chemistry, organic chemistry, qualitative and quantitative analysis, biology, and biochemistry, but also courses, if offered, in physiology, molecular biology, and pharmacology. Computer education courses would also be helpful as computer programmes are used more and more frequently to assist in constructing the three-dimensional structures of chemical agents to determine whether they bind optimally to a defined target.
In research and development, pharmacists are involved in a wide range of activities like:
- At the interface between drug discovery and the early phase of drug development, pharmacist is involved in the characterization, optimization and selection of new drug candidates
- Pharmacist develops and tests new formulations and drug delivery systems
- Pharmacist develops analytical methods for new active principles and pharmaceutical forms and introduces new analytical techniques. He/she characterizes active principles chemically and physically and thus contributes to the successful development of dosage forms. The data obtained in the stability studies serve to determine the shelf life of products
- Pharmacist develops and optimizes new formulas and technical processes for the pharmaceutical formulations required for clinical trials and the market
- Working in accordance with GMP (good manufacturing practice), pharmacist produces test preparations for clinical trials.
Thus, through playing an increased role, the pharmacists can become a more important link in the health care delivery mechanism and create new standards comparable to developed world in ensuring better quality in the lives of the people.
- (The author is deputy drugs controller Bangalore (Hqs), Drugs Control Department Government of Karnataka, India)