This post has been de-listed (Author was flagged for spam)
It is no longer included in search results and normal feeds (front page, hot posts, subreddit posts, etc). It remains visible only via the author's post history.
Citation: Sengupta A. Accelerating drug development and approvals in India. Regulatory Focus. 30 November 2022 [archive]
India’s Central Drugs Standard Control Organization (CDSCO) implemented the New Drugs and Clinical Trials Rules in 2019 to expedite the drug development and approval processes. This article provides an overview of those processes; explains the rule-specific terminology, such as the definitions of “drug” and “new drug” under Indian law; and outlines strategies for speeding up the approval processes and optimizing registration of prescription medicines in India.
Keywords – accelerated approval, CDSCO, clinical trials rule, CMC, India, new drugs
Table of Contents
- Introduction
- Drugs versus new drugs
- CDSCO: Structure, strategy, and responsibilities
- Regulatory framework
- Advantages and disadvantages of the 2019 new rules
- Regulatory pathways
- Regulatory strategy
- Stability study requirements
- CMC requirements for new drugs
- Application review timelines
- Conclusion
Subreddit
Post Details
- Posted
- 1 year ago
- Reddit URL
- View post on reddit.com
- External URL
- reddit.com/r/RegulatoryC...