Recording from Tuesday, October 13, 2020

This Webinar provided an overview of current excipient related regulations in India for the domestic and export markets along with a preview of some potential emerging challenges.
Topics include:

Current Regulations
> Overview of responsible agencies and standards for drug regulation in India
> Excipient regulatory and testing requirements
> Excipient information needed for drug application approval
> Licensing and registration of excipients – local and imported
> Regulations for colorants and flavors permissible for use in drugs in India
> Interpretation concerns for excipient control

Emerging Challenges
> Microbial limit test for pharmaceutical raw materials
> Imported drug products compliance to D&C Act & Rules of India
> Indian Pharmacopoeia (IP) compliance for imported excipients
> Elemental impurities – Indian Pharmacopoeia
> Regulatory status of Nutraceuticals / dietary-health supplements

Learning Objectives
> Overview of the framework of the drug approval process in India
> Understanding current excipient requirements and information needed to support domestic and export drug applications in India
> Awareness of regulatory requirements for Indian colorants and flavors
> Review of current and future Indian Pharmacopoeia concerns
> Awareness of emerging challenges related to excipients in India