India – India Posts Guide to Revised Rules on New Drugs and Clinical Trials

India’s Central Drugs Standard Control Organization (CDSCO) has posted a guide to its new drugs and clinical trials rules. The document addresses common questions about the new rules, such as when clinical trial sponsors can benefit from a fast track open to India-focused development programs.

The Indian government published the New Drugs and Clinical Trial Rules, 2019 last month. Through the document, India is making significant changes to the rules governing how drugs are developed in the country, generally in ways that have met the approval of the biopharma industry in the country and overseas.

To help companies understand the implications of the rules, CDSCO has shared answers to frequently asked questions about the regulations. The document covers everything from very broad and basic questions, such as, “What is an investigational new drug,” to more specific inquiries…