Production of “Clinical Trial” Materials - Regulatory Supervision in India

K. Bhargava

Introduction: Contract Research Organizations (CROs) and pharmaceutical manufacturers in India are engaged in clinical trials of drugs for number of years. India and several other Asian countries are engaged in new drug development for last decade or so, ญญญญญญญญญญญญthe landscape, however has greatly changed in last 5 years. We all share in the responsibility to work together to strengthen the science used in pharmaceutical development, evaluation and review. India too, with its strong educational science base, is attracting more and more multi-regional clinical trials. These trials are being reviewed both in quantity and quality from the perspective of pharmaceutical industry.

With a retrospect of last 10 years or so, and current situation, I will be mentioning here few regulatory supervision points for production, manufacture and packing of new drug items and making these ready for phase I, phase II and phase III clinical trails. If we go through regulatory texts available for clinical trial materials, various nomenclatures are used for investigational medicinal products. These in India are known as “new drugs” and have been defined under rule 122 E of Drugs and Cosmetics Rules. In some countries these are termed as “investigational medicinal products or IMPs” and WHO texts mention these items as “Investigational Pharmaceutical Products for Clinical Trials in Humans”. Organizations like PIC/S and others have used similar terms.

New drugs, before marketing in India have to undergo clinical trails and to regulate clinical trails “Schedule Y” of Drugs and Cosmetics Rules was framed. Schedule Y, from its original form has undergone expansion and changes from its original form in past few years. Since this schedule was principally meant to regulate the activities in a research organization or contract research organization (CROs), the contents in this schedule cover medical and pharmacological aspects on par with number of other texts from regulatory agencies of other countries and WHO. Since the first appearance of “schedule Y”; pharmaceutical aspects of “new drugs” i.e. several conditions controlling manufacture of these products were not mentioned.

Schedule Y & GMPs
However in its latest amendment “schedule Y” has mentioned that the item meant for clinical trial is to be manufactured under GMP conditions. Thus for a common understanding, the item is to be manufactured following conditions mentioned under our “schedule M” of Drugs & Cosmetics Rules. Readers carry an impression that schedule M is applicable to licensees possessing licenses in forms 25 and 28 and manufacturing products for regular use, it is left to understanding and interpretation of a particular licensing authority in the country, if GMP conditions mentioned in Schedule M are also to be made applicable to those who are granted “test license” in form 29.


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