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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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