RESUMO
BACKGROUND: New drugs are appearing in the Indian pharmaceutical market every day. To study the trends we analysed the pattern of new drug approvals and introductions in India over the past 15 years (1988-2002). METHODS: Lists of new drugs approved by the Drugs Controller General of India, released half-yearly, were obtained and entered into a computer database. Additional information, such as anatomical therapeutic chemical coding, availability status till 31 December 2002 and source were added to this database before analysing overall time trends and the situation in individual therapeutic categories. RESULTS: Excluding unrecognized and compound formulations and 28 veterinary products, 396 drugs were approved for clinical use during this period. Of these, 315 have also been launched in the market and 5 were subsequently withdrawn. Nervous system-related drugs accounted for the largest number of approvals (82), followed by antimicrobials (73) and cardiovascular drugs (57). Five new antimalarials have emerged but other tropical diseases have been mostly ignored. Eleven vaccines have been added. CONCLUSION: There has been a sharp spurt in the annual number of approvals and introductions. The proliferation of brands and fixed-dose combinations has kept pace with the introduction of new molecules. Unfortunately, most new drugs are not major therapeutic advances. In the context of this rapid proliferation, meeting the information needs of prescribers, establishing an effective nationwide pharmacovigilance system and reorienting the focus of pharmacology education--from information provision to development of self-learning and critical judgement skills-are some issues for concern.