Vaccines in the United States: a systematic review on history of evolution, regulations, licensing, and future challenges.

Vaccines are credited with reducing or effectively eradicating a number of infectious diseases such as smallpox, measles, and diphtheria. Particularly in nations like the United States, where a large number of infectious diseases were prevalent, vaccines proved to be timely interventions. The approval procedure for vaccines in the United States is regulated by the Center for Biologics Evaluation and Research. Vaccine development is often found to be demanding and requires astute knowledge and understanding of recent developments by physicians and researchers to ensure that effective vaccines are made available to the masses with minimum risk. This article aims to illustrate the regulatory scenario with regards to vaccine development and licensure in the United States with a brief look at the origin of vaccines and their regulations in the nation. Also, it details the challenges faced by the United States vaccine industry to remain relevant in today's constantly evolving world.

A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials.

Pharmacovigilance is the pharmacological science associated with the detection, understanding and prevention of adverse effects, especially long-term and short-term adverse effects of medicines. In the present day pharmaceutical scenario, where the development and marketing of an ever-growing array of medicines has rendered their safety and therapeutic efficacy key to determining the success of a drug, pharmacovigilance has come about to play a critical and significant part. While pharmacovigilance, as a system, has witnessed considerable progress and evolution in the West, not as much has been accomplished in India. With India now being recognised as a hub of global clinical trials and with an increasing number of clinical trials and clinical research studies being conducted actively, the need for a dynamic pharmacovigilance network with an efficient and prudent operation methodology is felt, now more than ever. This article observes the evolution of the pharmacovigilance system in India, with a fundamental overview of the present system in place and also various schemes and proposals to establish and sustain the same. It also examines the challenges faced in the execution of an effective pharmacovigilance network as well as the future prospects with regards to the Indian market.