CLINICAL DRUG DEVELOPMENT IN DEVELOPING-COUNTRIES - THEORY AND PRACTICE, MYTHS AND REALITIES

Development of new drugs, new formulations of old drugs for existing and new indications, and their consequent promotion, are parts of a balanced and disciplined structure in almost all developed countries. This structure is dependent on the responsible and reconciliable role of each of its four important segments - doctors, consumers, governments and pharmaceutical companies. The evidence hitherto available from many developing countries suggests that the contribution of each of the above important and interdependent balancing influences on drug development falls far short of its obligations to the population at large and to responsible health care. Examination of the Indian scenario confirms beyond doubt this regrettable observation. Although drugs do not guarantee health, availability of essential drugs at affordable prices, elimination of all irrational and hazardous drugs and drug combinations, cessation of indiscriminate proliferation of an already bewildering array of many thousands of formulations, and availability of information on drugs to the public, are mandatory changes long overdue in all developing countries, including India. Furthermore, the enforcement of Good Manufacturing Practice (GMP) and Quality Assurance (QA), by statutory measures, if necessary, and implementation of guidelines of Good Clinical Practice (GCP), are the needs of the hour. These and other related issues will be discussed in this paper.