With a view to guide the stakeholders (including drug manufacturers, analysts, academicians) on drafting of drug monographs before their inclusion in the Indian Pharmacopoeia (IP), Indian Pharmacopoeia Commission (IPC) has come out with the publication of ‘Guidance Document for Drafting and Formatting of Monographs for Indian Pharmacopoeia’. This Guidance Document was released by Shri Rajesh Bhushan, Secretary, Ministry of Health and Family Welfare, Government of India on 16th February 2021. In this Guidance Document emphasis has been given to elaborate IP monographs under the categories of Active Pharmaceutical Ingredients (APIs), Dosage Forms, Pharmaceutical Aids & Excipients, and Herbs & Herbal Products. It is expected that this Guidance Document would be found useful by the stakeholders to draft the drug monographs intended to be included in the IP.  

 

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Guidance Document for Drafting and Formatting of Monographs for Indian Pharmacopoeia

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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