Abstract

B. Poonam Sai* and B. Venkata Ramana

ABSTRACT

In India import, manufacturing, sale and distribution of drugs is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic rules 1945. At present, bulk drug. Any substance falling within the definition of drug (Section 3b of the Act) required to be registered before import into the country. The application for registration and import can be made to the Licensing Authority under the Act i.e., to the Drugs controller General (1) at CDSCO, FDA Bhawan, New Delhi by the Local Authorized Agent of the foreign manufacturer having either manufacturing or sale Licensing or by the foreign manufacturers having a wholesale License in the country. This document has been prepared to specify the general requirements for approval of clinical trial and different categories of New Drugs viz. Investigational New Drugs, New drugs substances, additional strength, additional indication, modified release form etc. This will help the industry to submit the required documents in a more realistic manner, which in turn will also help reviewer of CDSCO to review such application in systematic manner. SUGAM is e-Governance system to discharge various functions performed by CDSCO under Drugs and Cosmetics Act 1940. The software system developed is an online web portal where applicants can apply for NOCs, licenses, registration certificates, permissions and approvals. It provides an online interface for applicants to track their applications, respond to queries and download the permissions issued by CDSCO. It also enables CDSCO officials to process the applications online and generate the permissions online and generate MIS reports. Demonstration of safety and efficacy of the drug product for use in humans is 1essential before the drug product can be approved for import or manufacturing and marketing in the country. The Rules 122A, 122B and 122D, 122DA, 122E of Drugs and Cosmetics Rules and Appendix 1, 1A and 6 of schedule Y, describe the information or data required for approval of clinical trial and/ or to import or manufacture of new drug for marketing in the country.[1]