new drug approval from DCI

[sonu parsad]

Dear All,

Kindly let me know the procedure to get new drug approval from DCI

What are the documents require for the same. How much time will be taken by DCI

or Any other information

Pls advise.

regards,

Sonu Parsad

AI Summary

Understanding New Drug Approval Process in India: Key Steps, Schedule Y Guidelines, and Timelines for DCGI Approval A user inquired about the procedure for obtaining new drug approval from the Drug Controller General of India (DCGI). The response outlined that the Drug and Cosmetic Act 1940 and Rules 1945 regulate drug approvals, with Schedule Y providing guidelines for clinical trials. Clinical trials are categorized into two groups, with fast-tracking available for drugs approved in certain countries. Applications must include detailed data and be approved by both the DCGI and an ethical committee. The process involves multiple phases of trials, and new drug registration requires comprehensive documentation. Approval can take 12-18 months, after which Phase IV trials may occur.