Pharmaceutical Regulatory Affairs: Open Access

Historical Overview of Pharmaceutical Industry and Drug Regulatory Affairs

Abstract

Hasumati Rahalkar

In this chapter, we have studied that drug regulations and pharmaceutical industry has developed due to circumstances faced by the Health Authority (HA) at that time. For USA, the root for vaccine industry development was the vaccine tragedy. In response to that The Biologics Act of 1906 came into force shifting vaccine manufacturing from health authority to Vaccine Industry. Due to issue of Safety and efficacy, pre-marketing approval with scientific safety data becomes mandatory. These regulations were further defined by classifying drugs into Over-The-Counter (OTC) and Prescription Only category. The USFDA has grown from one chemist to more than 9000 employees currently. In summary, US Health Authority has grown from one chemist to more than 9000 employees, no scientific data to pre marketing approval with scientific data, drug categorization and various regulations for new drugs, biologics as well as marketing authorization. In Europe, due to thalidomide tragedy, 65/65/EEC came into effect mandating marketing authorization. Pharmaceutical legislations pertaining to drug development as well as marketing authorization procedure become quite clear and transparent. EMEA committee was developed for centralised application assessment. In India, the drug industry has grown from API manufacturing through reverse engineering to pure research and development. Regulatory Authority of India issued guideline for Fixed Dose Combination, Implementation of Common Technical Dossier (CTD), Clinical Trial Registry of India (CTRI) as well as Pharmacovigilance cell. Under Drug Regulatory Affairs section, we have studied the link of Global, Regional as well as National Regulatory Network. We have learnt that Regulatory Affairs professionals are very critical and important for the national and international business of pharmaceutical industry. Regulatory network in pharmaceutical industry indicates that communication and advice to various departments in Industry is very essential. He /she plays an active role in defining guidelines nationally and internationally.