Last Updated On: 05/07/2013


Submission of New Monographs for IP

Industry and stakeholder participation in IPC’s public standard-setting process is essential to the development of authoritative, relevant IP monographs. You can help by submitting new monographs. You can also review and comment on the draft monographs published in our website www.ipc.gov.in.

IPC encourages you to submit draft monographs for your API’s and dosage forms as well as excipients. Your draft monograph will become the starting point for the official public standard. IPC staff will involve you in a process of public review and comment to refine and finalize these monographs for publication in the IP.

The following items are required to submit a new monograph to IPC.

S. No.

Items required

1

Monograph inclusion form (available on our website www.ipc.gov.in)

2

DCG (I) approval letter

3

Sample approximately 50 g (API) / 30 Nos. (Formulations)

4

Reference Standard/ Impurity Standard approximately 100 mg with COA

5

Validation data (Soft copy/ hard copy)

6

Monograph drafted in IP format

 

The stakeholders may send soft copy of draft monograph along with validation data at ipclab@vsnl.net and hard copy of data, sample, reference standard and impurity standard to Indian Pharmacopoeia Commission,

Sector – 23, Raj Nagar,

Ghaziabad. 201002.