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. 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.

2.

. 3.

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