Form IX

Mandatory Update of Form IX details & Auto-Approval for Non-Form C in FoSCoS.

Posted by: Hitesh Gupta March 2, 2025

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2nd March, 2025

What's New 2?

Regulation/Guidelines

Role & Responsibilities of Authorized Agent for Drugs in India

The role of authorized agent responsibilities is critical for foreign Pharmaceutical companies seeking to register, Import, and market Drugs in India while ensuring full regulatory compliance with CDSCO requirements. An...

12th May, 2026

Regulation/Guidelines

How to Get a CDSCO Import License in India: A Step-by-Step Guide for Foreign Medical Device Companies

In India given its large population and ample growth opportunities, remains one of the most attractive markets for global Medical Devices company. But entering Indian market is not so easy...

11th May, 2026

Regulation/Guidelines

Pharmacovigilance Regulations For Imported Drugs In India

Pharmacovigilance ensures that Drugs are continuously monitored for safety, quality, and efficacy through structured reporting systems and regulatory oversight mechanisms post-approval. In India, the pharmacovigilance regulations for imported drugs are...

6th May, 2026

Regulation/Guidelines

Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing

Artificial intelligence in pharmaceutical manufacturing can help support quality control, decision-making, process monitoring, batch evaluation, and data management by analysing complex production data to improve efficiency and product consistency. However,...