Vaccine policy, regulations and safety in India

Abstract

Vaccine development in India, though slow to start, has progressed by leaps and bounds in the past 60 years trans- forming 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 regu- lated 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. 1. Introduction and historical perspective India with its population of over a billion people and 26 million new births each year is both a major buyer and vaccine maker (27). The current Indian market for vaccines is estimated to be about US$ 260 million (17). Vaccine research and production in the country were driven during the period of British colonization when they established 15 vaccine institutes in the country beginning in the 1890s. These were necessitated due to the deaths of their troops owing to tropical diseases. At the time of departure of the British in 1947, Indian vaccine production lagged behind and most vaccines in the country were introduced a decade after they were introduced in the rest of the world (27). 1.1. Development and growth of Indian vaccine manufacturers Most Indian vaccine manufacturing companies were set up after the country's independence with the aim of being self reliant and manufacturing life-saving immuno-biologicals, which were in shortage in the country and obtained from the developed world at high prices. This is evident in the mission and vision statements listed on the individual manufacturers' websites. Currently, there are at least 13 major vaccine manufacturers in India and the number is only expected to increase. India is a major supplier of vaccines to UNICEF that in turn meets approximately 40% of the global vaccine demand for routine childhood vaccination in nearly 100 developing countries. The Haffkine Institute in Mumbai (Bombay) was established in 1899 and is perhaps the oldest vaccine manufacturer in the country. The first ever Phase I trial in the country was conducted here with the founder injecting himself with the plague