[e-drug] chromatographically purified vancomycin? (3)

e-drug
1

E-DRUG: chromatographically purified vancomycin? (3)
----------------------------------------------------

dear e-Druggers,

As per Drugs and Cosmetics Rules of India, Vancocin CP (vancomycin CP) is a "new drug" [Rule 122E(b)] and hence should undergo the following procedure:

(1) Phase III clinical trials on Indian patients
(2) Marketing approval from Drugs Controller General, India (DCGI)
(3) Monograph duly approved by DCGI (due to being a new drug with new claims).
(4) Manufactruing Licence from the state drug controller where the facility to manufacture Vancosin CP is located.

Hence Dr. Gitanjali Batmanabane should ask the Company to provide the above details with photocopies of the relevant documents.

regards

Dr. Chandra M. Gulhati
Editor, MIMS
(Monthly Index of Medical Specialities),
New Delhi 110019. India.
e-mail: indianmims@yahoo.co.in

2

E-DRUG: Chromatographically purified vancomycin? (5)
----------------------------------------------------

Dear Dr Gulati,

Also, if I may add, ongoing post marketing surevillance and the results of it for Vancocin CP, to better understand the safety of this drug.

Kind regards

Pipasha
Dr Pipasha Biswas
MD MFPM DM MRQA
Principal Consultant & Director
Symogen Ltd
www.symogenlimited.com