European Journal of Biomedical and Pharmaceutical Sciences

PHARAMACEUTICAL REGULATORY AGENCIES OF INDIA

Syeda Rakhshinda Zareen*, Dr. Osman Ahmed, Reshma, Mohammed Sayeed Uddin and Dr. Anas Rasheed

ABSTRACT

Pharmaceuticals have the potential to improve a nation's economy, save countless lives, and even assist prevent or control the spread of disease. This clarifies the need for monetary investment in medicine on the part of consumers, governments, pharmaceutical firms, and educational establishments alike. Yet this can only occur if there is confidence in the medicine's safety, effectiveness, and quality. This means the pharmaceutical sector, from discovery to production to retail, is under close watch to ensure the safety and efficacy of the drugs at every stage. To ensure that pharmaceuticals are effectively managed and to protect and improve public health, governments establish powerful National Regulatory Authorities (NRAs) to supervise the regulation of pharmaceuticals. Laws governing the production and distribution of pharmaceutical products are crucial to preserving public health and preventing damage from substandard medicines. The pharmaceutical regulatory agency is responsible for enforcing laws and offering guidelines in the following areas: drug development, licencing, registration, manufacture, labelling, storage, marketing, distribution, price, import, and post-market research. Pharmaceutical businesses that aim for a worldwide market are also subject to the often more stringent regulations of other governments. One regulatory approach for a medical product's Marketing Authorization Application (MAA) that may be utilised in several countries may be difficult to identify. The electronic submission of applications for pharmaceutical registration is now standardised thanks to Common Technical Document (CTD). This article provides an overview of the pharmaceutical sector regulatory agency in India.

Keywords: Regulatory Agency, CDSCO, US FDA, EMA, Marketing Authorization Application, Common Technical Document.