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IP-USP
collaboration identify key areas
Jayashree
Padmini - New Delhi
Identifying
India as a potential market for pharmaceuticals and in an effort
to develop it as an ideal sourcing base for raw material like APIs
and bulk drugs, the co-operation efforts between US Pharmacopoeia
(USP) & Indian Pharmacopoeia (IP) are being strengthened. The
recent collaborative effort initiated to bring IP and USP closer
has identified the key areas of co-operation in a recent meeting
in Hyderabad.
Roger
Williams, CEO, USP Commission with a six member team, has in a meeting
with Indian regulatory authorities and IP Committee members deliberated
on the scope of the joint effort to representatives from countries
such as Canada, Thailand, Nepal, Indonesia, etc. The objective is
to involve India in the global effort to exchange information along
with counties like Japan, UK, European Union and in a small way
China and South Africa.
The
prime objective of collaboration is to evolve uniform standards
on stability, impurity profile, excipients, referral standards and
nutraceuticals. WHO also is involved in the effort to develop stability
norms to ensure uniform shelf life and storage conditions for certain
category of drugs, like vaccines, anti-TB FDCs, antibiotics, etc.
Scope of the joint effort also envelope fixing the limit of organic
volatile impurities (OVIs) to harmonize with ICH guidelines, standardize
and draw up monographs for excipients and evolve an acceptable set
of standards for nutraceuticals.
A
15-member committee called Quality Communications Group, comprising
representatives from industry and regulatory authorities is constituted
and an Asian edition for monographs is being worked out. USP is
said to be keen about sourcing referral standards from India and
is considering the proposal to establish synthesis of referral standards
in the research institutes with grant from US.
Representatives
from Thailand, Nepal, Canada, were also invited to the conference
in Hyderabad with the objective of sensitizing other countries also
on the need for harmonization. Thailand, Nepal and Canada doesn’t
have own pharmacopoeia.
Nepal
follows USP and IP, Thailand (USP) and Nepal, which mainly depends
on IP or BP, now plans to have own pharmacopoeia. Canada is far
advanced in technology that it could directly adapt to BP and does
not find the need to evolve own pharmacopoeia. In countries like
India where technology is not matured enough to adapt USP or BP,
the collaborative exercise with USP would help to offset the adverse
impact and help Indian industry explore global markets with more
ease.
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