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The formulation of international requirements for the manufacture and control of BCG vaccine was first considered by the WHO Expert Committee on Biological Standardization in its thirteenth report. In its fourteenth report, the Committee requested WHO to make arrangements as soon as possible for the formulation of such requirements. These requirements were approved by the WHO Expert Committee on Biological Standardization at its eighteenth meeting and appeared as Annex 1 to its report. Vaccines are important preventive medicines for primary health care, and are a critical component of a nation's health security. Although international agencies such as the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) promote global immunisation drives and policies, the success of an immunisation programme in any country depends more upon local realities and national policies (Box 1). This is particularly true for a huge and diverse developing country such as India, with its population of more than 1 billion people, and 25 million new births every year. The current Indian market for vaccines is estimated to be about US$260 million. India is among the major buyers and makers of vaccines, locally as well as globally, and has traditionally aimed at self-reliance in vaccine technologies and production. This article explores the trajectory of vaccine policy in India through its historical roots and institutional development, the gaps in demand and supply, the changing nature of the vaccine industry, and the emerging challenges in meeting national immunisation targets. ​

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