New Drug License and Clinical Amendment Rules

New Drug License is required for businesses that wish to manufacture or sell new drugs in India. The process includes submitting an application with details about the drug, its ingredients, and clinical trial results. Clinical Amendment Rules are guidelines that regulate the approval process for new drugs, ensuring safety and efficacy. At Agile Regulatory, we assist with the entire process, helping you navigate through the application, documentation, and regulatory requirements to obtain the necessary licenses.