Page 27 - ITPS-7-4

INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

and the ICH E11. Figure 1 illustrates the pediatric age 2. Need for clinical trials on the pediatric
2
classification along with physiological and biological population
changes.
Clinical trials conducted on pediatric populations
It is crucial to establish and specify the necessary are essential for several reasons. Firstly, children have
instruments for acquiring trustworthy information to different physiological and metabolic characteristics
ensure the quality, safety, and effectiveness of medications compared to adults. These differences can greatly
17
intended for children. Due to a lack of readily accessible and impact the safety and effectiveness of medications,
3
age-appropriate formulations, providing pharmaceuticals making it crucial to study them specifically in pediatric
to the pediatric population can be challenging. Many populations. Secondly, certain diseases and conditions
4-7
18
medications prescribed for children are formulated may manifest differently or exclusively in children,
for adults, necessitating dose adjustments throughout necessitating the need for targeted research and clinical
childhood. This may involve physically altering a dosage
8
form to achieve a smaller dose, such as splitting a tablet trials in this population. Thirdly, ethical considerations
or diluting an injection. While these practices are play a significant role in conducting clinical trials on
9
common among health-care professionals, there is limited pediatric populations. Children cannot provide informed
information on the potential risks associated with these consent like adults, so it is essential to have specialized
manipulations, including time-consuming procedures regulations and guidelines in place to protect their rights
and uncertain effects on drug stability and effectiveness. and ensure their safety during clinical trials. In addition,
10
Consequently, there is a risk of administering either toxic performing clinical trials in pediatric populations allows
or ineffective doses to children. 11,12 health-care providers to gather valuable information on
the safety and effectiveness of medications in pediatrics of
Error risk may also increase due to drug manipulation. different age groups. Furthermore, the lack of available
19
In pediatric and neonatal treatment, dosage calculation child-appropriate dosages and application forms for
errors are the most common pharmaceutical errors. medications also highlights the need for pediatric clinical
13
Economic factors have led to the encouragement of tablet trials in India. Figure 2 represents the considerations
20
manipulation among adults in several nations. There during the pediatric clinical trial. 62
may be a small distinction in tablet characteristics 14,15
(Tables 1 and 2). Thus, splitting tablets might be more By conducting advancements in the regulations of
economical than purchasing them in the correct dosages. clinical trials, specifically in pediatric populations, we can
An efficient survey conducted in this region recognized bridge the knowledge gap and provide evidence-based
6
only one product (including suppositories) that did not treatment options for children, ensuring their optimal
have a correlation with tablet splitting. 16 welfare and health care. 21

Figure 1. Pediatrics age classification with physiological and biological changes
Abbreviations: BBB: Blood–brain barrier; CNS: Central nervous system.

Volume 7 Issue 4 (2024) 2 doi: 10.36922/itps.3831