chapter  6
50 Pages

India

BySubhash C. Mandal, S. Ravisankar

INTRODUCTION Although the concept of bioavailability (BA) and bioequivalence (BE) has been developed over the decades and such considerations are in practice in different research centers in academic institutions and industries in India for quite some time, BE testing was not made mandatory by Drug Regulatory Agencies, until the 1980s. The introduction of dissolution tests for seven products, chlorpromazine, digitoxin, digoxin, lithium carbonate, quinidine, tetracycline, and tolbutamide in the Indian Pharmacopoeia in 1985 (1), initiated the process of framing legislation for regulatory requirements of BE studies. After this phase (three years), BE studies became mandatory for all new drugs introduced on the markets in India, by incorporating Schedule Y of the Drugs and Cosmetics Act in 1988, followed by subsequent amendments of Schedule Y in 1989 and 2005 (2). The term “new drug” in India is defined under 122E of the Rule and includes both brand and generic.