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INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

Table 1. Physiological parameters of pediatrics comparable
to the age of adults 14,29,65,66
Physicochemical specifications Age at which comparable to Ethical
adults* consideration
Enteric pH 2 – 3 years
Gastric emptying 8 months Timing and
Extrapolation types of
Intestinal colony formation 1 – 4 years studies
Passive and active transportation 4 months
in the gastrointestinal tract
Considerations
Hepatic circulation 1 year during pediatric
clinical trial
CYP3A expression in the 6 – 18 months
duodenum
Plasma protein levels 1 year Formulation Excipient
challenges toxicity
Liver Phase I metabolism 0.5 – 3 years
Few attain maturity
levels at 10 – 12 years Age-based
Some changes occur during classification
childhood of pediatric
population
Hepatic Phase II metabolism 3 years (Few reach maturity by
10 years)
Glomerular filtration rate 1 – 2 years Figure 2. Considerations during pediatric clinical trials 62
Note: *These ages are approximate and may vary according to the
literature.
3.2.2. European Union (EU) guidelines on pediatric use
3. The imperative for implementing Similarly, in 2007, the EU published the EU guidelines
pediatric drug regulations in India on medicinal formulations for pediatric use, which
mandate that pharmaceutical industries submit pediatric
3.1. Current challenges in pediatric drug investigation plans (PIPs) to the European Medicines
development Agency (EMA).
Guidelines and the acceptance of pediatric drugs are These regulations aim to ensure that children can take
critical aspects of ensuring the safety and effectiveness safe and effective medication that has been specifically
of medications for pediatrics. Different countries have tested and approved for their age group. In contrast, the
established their own regulatory frameworks and processes current scenario in India lacks specific drug development
to facilitate the advancement and accessibility of age- regulations for pediatrics. Similar to the EMA’s Pediatrics
appropriate medications for pediatric use. Committee or the US Food and Drug Administration
(FDA)’s Office of Pediatric Therapeutics.
3.2. Global regulatory frameworks and their impact
3.3. Efforts and recommendations for improvement
One of the main reasons for the absence of age-appropriate in India
versions of original medications and their generic India currently lacks a distinct department or regulatory
equivalents is due to lower anticipated profits, logistical structure devoted to pediatric medication development.
challenges, and extra developmental work. This can make This lack of specific guidelines for pediatric drug
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it challenging for pharmaceutical industries to invest in the development poses challenges in ensuring the safety and
development and testing of pediatric drugs. effectiveness of medications for pediatrics. Furthermore,

3.2.1. The pediatric research equity act (PREA) in the the lack of pediatric-specific guidelines in India has led
United States (US) to irrational drug use and the unavailability of proper
dosing information for children. However, it is important
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For instance, in the US, the PREA was enacted in 2003, to note that there have been recent efforts in India to
requiring pharmaceutical companies to perform pediatric improve the regulation of pediatric drugs. One such effort
clinical research on new pharmaceutical medicine and is the incorporation of pediatric clinical trials into the
biological products before they can be marketed. 18 regulations for new drug approvals, ensuring that new

Volume 7 Issue 4 (2024) 3 doi: 10.36922/itps.3831