CASE STUDY ON DRUG REGULATORY BODIES IN STATES OF INDIA: A NEED FOR UNIFORMITY Research Article

The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency (regulatory body like FDA) pertaining to transfer of regulatory information. The content is based on the Common Technical Document (CTD) format of ICH. The regulatory bodies encountering NDA, ANDA and alike have to receive the respective documents which comprises a large amount of data in paper form. Sometimes the NDA application is like more than thousands of files. This amounts to usage of a paramount papers/stationary etc. Present case report is an attempt to study the aforementioned application of electronic transactions in regulatory affairs (import of drug, permission for marketing, permission to carry out clinical trials etc.) in different states in India pertaining to its similarities or dissimilarities A survey was carried out on internet to look for websites of regulatory bodies of all states and to reveal whether the websites/webpage of the regulatory body is under the agencies of some ministry or a statutory body itself or some autonomous body. The objective was simply to know the harmony between regulatory bodies all the states. The case report is indicative of non uniformity amongst the Govt. sector with respect to drug control. The present situation demand the harmony is this matter.