For New Drug application of a novel phyto-constituent; provide list of submissions.
[6 marks]Describe how different regulations help in streamlining manufacturing and uniform quality of natural products.
[5 marks]Enumerate parameters of WHO guidelines for quality assessment of crude drugs.
[5 marks]Describe in detail; 1. Extractive value 2. Ash value 3. Bitterness value
[6 marks]Explain how a pure phyto-pharmaceutical can be asses for quality by WHO guidelines?
[5 marks]Provide full form and objectives of following GACP guidelines.
[5 marks]Describe in detail from GACP guidelines; 1. Propagating material 2. Irrigation 3. Pest control
[6 marks]Provide Good Collection practice for roots and bark.
[5 marks]Write in detail about Post harvesting primary processes practices.
[5 marks]Differentiate EU guidelines from ICH guidelines for quality and stability study of medicinal constituent.
[6 marks]What stability study practice is required to prove stability of a plant constituent?
[5 marks]Provide definition, significance and Process of Phyto-pharmacovigilance.
[5 marks]Write a note on OECD 420 and OECD 425 guidelines for drug safety.
[6 marks]Write detailed classification of markers with examples.
[5 marks]Provide all the components of Adverse Drug Reaction report. Q. 6 (a) Enlist guidelines GMP given in Schedule Tof Drugs and Cosmetics Act of India.
[6 marks]Describe details of prescribed Good Laboratory Practice with emphasis on record keeping.
[5 marks]Describe Indian EXIM policy in brief and give details o document required for import of medicinal plant product.
[5 marks]Write role of different Herbal Pharmacopoeias in Herbal Drug market.
[6 marks]As per current Good Manufacturing Practice, describe ideal practice for STORE, STORAGE AREA and EQUPMENTS HANDLING for a herbal drug Industry.
[5 marks]Write a note on efficacy study of herbal drugs.
[5 marks]