Transcript Current issues and challenges in the development of IP monographs

Current issues and challenges in the
development of IP monographs
Dr. G.N. Singh
Secretary-cum-Scientific Director
Indian Pharmacopoeia
Commission
Ghaziabad.
•
Indian Pharmacopoeia is the official book
of standards for drugs included therein, in
terms of the Second Schedule to the Drugs and
Cosmetics Act, 1940so as to specify the:
Standards of identity, purity and strength for the
drugs imported, manufactured for sale, stocked
or exhibited for sale or distributed in India.
It is a reference document for various
stockholders like enforcement agency, industry,
lab,
academic
institutions
etc.
Compliance with IP Standards by drug
manufacturing industry assures
consumers,
patients and
healthcare professionals
of
their quality.
As India is the best developer of generic
pharmaceuticals and taking the lead in adopting new
technologies
Therefore there is a need for the sustainable
compliance of quality specifications of drugs and
pharmaceuticals.
IP ensures the control of the quality of not only the
formulations (dosage forms)
but also of the
active
pharmaceutical ingredients (APIs).
Current Issues

Amendments to IP 2007 have been published in IP
Addendum 2008. Further amendments are to be taken
care of in IP 2009 edition.

Publication of IP 2009 by Dec. 2009 is the immediate
priority. Work is in full swing.
 159
Drug molecules have been short listed
for the IP 2009. The APIs and their
formulations monographs are being
prepared at the IPC.
 Monograph
inclusion/deletion criteria and
the Monograph Inclusion Form have been
uploaded on the website of the Commission.
Indian National Formulary
1st Edition 1960
2nd Edition 1966
3rd Edition 1979
It is a reliable reference book on drugs
formulations for the practicing physicians/
clinicians, pharmacists, clinical pharmacists,
nurses and others engaged in healthcare
profession.
It will enable the public to obtain treatment at
reasonable cost.
It will form an integral part of rational
therapeutics as far as teaching institutions are
concerned.
The draft of the INF is ready for the comments
Challenges
1.
Arrangement, procurement, preparation, evaluation,
containerization and distribution of all the IP Reference Substances is
still a challenge for the Commission.
2.
.
3.
The Commission has identified the Chemical
Reference
Substances and impurities RS required on the priority
basis and 115 Reference Substances certified by the
Commission. The issue of the remaining ones
is to be addressed shortly.
Collaborative testing with NABL accredited laboratories, before
certification is imperative.
Training and Harmonization

IPC has the strategy to start pharmacopoeial
Education and Training Programme for generating
talented human resource.

Harmonization:

Collaborative efforts needed to bring
harmonization/uniformity of Standards.

It will reduce wastage of resources and time.

IPC already has tied up with USP. British
Pharmacopoeia Commission and EDQM are
also keen to have working relations with IPC.
Collaboration will lead to-
-Harmonization of general procedures/practices
-Harmonization of monographs
-Understanding each other
-Avoidance of duplicative testing
-Break the barriers of trade across the world