REGULATORY REQUIREMENTS FOR THE SUBMISSION OF NDA AS PER CDSCO IN INDIA COMPARISION WITH INDONESIA

Dr. Ashok Kumar P.*, Nagabushan K. M., Nagesh Kumar Y. S., Kumar C. Jadav, Rajendra Prasad L.,Nithish C.

ABSTRACT

A regulatory process is by which a person/organization/sponsor/innovator gets authorization to launch a drug products in the particular market region by following respective regulatory guidelines. Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical sciences and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of new drug product to serve the public health. In general, a drug approval process comprises of various stages: application to conduct clinical trials, application to marketing authorization of drug and post marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. In the present scenario, different countries have to follow different regulatory requirements for Marketing Authorization Application (MAA) approval of new drug. In this article, we studied the new drug approval process and regulatory requirements in India and Indonesia according to their regulatory agencies.

Keywords: Central Drugs Standard Control Organization (CDSCO), United States of Food and Drug Administration (USFDA), New Drug Approval, Marketing Authorization Application (MAA).