to publish monographs of 12 antiretroviral drugs
Special Correspondent - Mumbai
Indian Pharmacopoeia is in the process of publishing an addendum
to include monographs of 12 antiretroviral bulk actives and their
20 dosage forms before the end of 2002 calender year.
bulk actives for which monographs are being designed include didanosine,
efavirenz, indinavir sulphate, lamivudine, nelfinavir mesylate,
nevirapine, ritonavir, sequinavir mesylate, stavudine, zidovudine,
abacavir and lopinavir. The dosage forms include tablets, capsules,
delayed-release and oral suspensions of the 12 bulk actives.
move to list monographs of antiretroviral drugs is the first step
towards upgrading the the IP monographs to international standards,
say IP Committee members. They informed that Dr Nitya Nand, chairman
of the IP Committee, plans to form small sub-groups of scientists
in different areas of expertise to bring about a total upgradation
in the IP monographs on par with international standards. In other
words, the IP Committee is in the process of a major revamp and
reconstitution to include experts with current knowledge in newer
technologies to update the monographs.
three-member working group has been formed to design
the monographs for antiretroviral drugs. They include Dr
V G Nayak of Cipla, Dr T G Chandrashekhar from Ranbaxy Laboratories,
and Dr K M Thomas from Aurobindo Pharma. It is interesting to note
that the members are the representatives of three major Indian companies,
which incidently are fierce competitors of anti-HIV therapies in
the domestic as well as international markets.
decision to design antiretroviral monographs crystallised following
the meeting of DCGI and Dr Nitya Nand alongwith the members of IP
Committee with Dr Kopp Kubel of International Pharmacopoeia and
WHO representative Andre Van Zyl. It may be mentioned that Cipla
had already submitted ten monographs of anti-HIV drugs last year
to the International Pharmacopoeia.
joint meeting was soon followed up with a meeting of the IP Committee
with the USP representatives for collaborative work to develop monographs
for inclusion in the USP (EPP 1 August, 02). A joint working group
has been set up comprising of Dr Roger Williams and Dr Srinivasan
from USP and Dr Ajit Dangi (OPPI), Dr V G Nayak (BDMA) and Dr Milind