Common Interview and Viva Questions

Differentiate the regulatory pathways for classical ASU medicines, patent/proprietary ASU medicines, and new phytopharmaceutical drugs in India.What is...

• Differentiate the regulatory pathways for classical ASU medicines, patent/proprietary ASU medicines, and new phytopharmaceutical drugs in India.
• What is Schedule T and what does it require of an ASU drug manufacturer?
• Distinguish GMP from GLP as applied to herbal drug development.
• What information is documented in CTD Module 3.2.S for a herbal drug substance?
• Explain the role of the Traditional Knowledge Digital Library in preventing biopiracy.
• Describe the traditional-use evidence duration required under the EU Traditional Herbal Medicinal Products Directive.