Abstract
Vaccine development in India, though slow to start, has progressed by leaps and bounds in the past 60 years transforming it from a nation completely dependent on imported vaccines to one not only self-sufficient in the production of vaccines conforming to international standards, but also a major supplier of the same to UNICEF. Vaccine development is tightly regulated by a hierarchy of regulatory bodies. Guidelines provided by the Indian Council of Medical Research (ICMR) set the rules of conduct for clinical trials from Phase I to IV studies as well as studies on combination vaccines. These guidelines address ethical issues that arise during a vaccine study. A network of Adverse Drug Reaction (ADR) monitoring centers along with the Adverse Events Following Immunization (AEFI) monitoring program provide the machinery for vaccine pharmacovigilance.