The journey of Indian GLP programme–looking back and forward

Abstract

AbstractThe Indian GLP (Good Laboratory Practice) compliance monitoring programme has successfully brought the task of implementing the programme to the foreground where full OECD (Organization for Economic Cooperation and Development) membership is about to happen. It has been a long journey, more than five years for the programme to arrive at this juncture, succeeding through sheer commitment and will of the Science and Technology initiatives under which the programme has been implemented. Considering the spontaneous and natural challenges that are bound to make the effort of implementing the GLP compliance programme tougher for any country, the progress made by the Indian GLP programme can be considered very rapid. Though the dawn of full OECD membership for the Indian GLP programme is imminent the paper deals with the details of the journey it has traveled so far and the challenges ahead, commending the commitment of the efforts of the GLP MA (Monitoring Authority) as well as the preparedness of the test facilities.This paper discusses the GLP policy aspects that favoured the growth of the programme among non‐member adherents, such as the allowance for getting GLP certification by GLP MA abroad. It also deals with the challenge of harmonizing the policies of the internal agencies that have direct influence on the implementation of the GLP programme, other than legalizing the GLP aspects as there are various government departments in India dealing with the regulatory aspects of specific drug products for human use or that are of chemical in origin. There are data requirements made mandatory by these institutions on pre‐clinical or non‐clinical safety evaluation of those products, which invariably necessitate studies conducted in compliance with the principles of GLP. The paper concludes with the emphasis that there is a primary need for harmony as well as legal or judicial underpinnings under the umbrella of a national GLP Monitoring Authority, a gray area to be essentially tackled with foresight, to earn credibility on the international front. Copyright © 2009 John Wiley & Sons, Ltd.