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INNOSC Theranostics and
Pharmacological Sciences Pediatric drug regulations in India

It is reasonable to assume that due to the short applies to novel uses, dosage forms, or pharmaceutical
availability of pediatric information, children often end versions of products that are already patented or covered
up taking medications meant for adult use. This off-label by a supplementary protection certification (SPC). Usually,
usage is not officially approved according to the product’s a PIP is necessary unless the EMA grants an exemption
summary of characteristics. based on product-specific reasons or class waiver approval.

The global off-label use of pediatric medications Compliance with this regulation makes the product eligible
exceeded 50% until the late 1990s, especially common for incentives under this legislation’s provisions.
in neonatology and intensive care. This trend reduced as 5.2. US
children grew older. As a result, it has become crucial to
establish regulations and define processes for obtaining In the US, there have been laws and regulations put in place
accurate information to guarantee the safety, quality, and since 1997 to support the development of medical products
effectiveness of pediatric medications. for children. The existing legislation includes the BPCA,
which offers incentives voluntarily, and the PREA, which
In 2010, the Pediatric Medicines Regulator’s Network mandates pediatric development under specific conditions
was established by the WHO in collaboration with Japanese without providing incentives. According to Chapter 5 of
regulators, the FDA, and the EMA to enhance cooperation the FDA’s Safety and Innovation Act, these two regulations
among regulators through promoting dialog and exchange were strengthened and enacted in 2012.
of information related to regulating pediatric medicines
at WHO headquarters in Geneva, Switzerland, on dated 5.3. BPCA
February 15 – 17, 2010.
Industries financially benefit from the BPCA’s enhanced
The list of participants in the Pediatric Medicines marketing exclusivity, which extends an existing patent or
Regulator’s Network is Australia, Azerbaijan, Brazil, exclusivity for 6 months for the entire product, provided
Canada, China, Chile, Croatia, Egypt, Europe, Ghana, that the sponsor completes the studies outlined in the
Indonesia, Malaysia, the Maldives, Moldova, Nigeria, written request (WR) from the FDA that grants this
Saudi Arabia, Singapore, Switzerland, Thailand, Ukraine, exclusivity. However, the extensive exclusive period applies
the United Republic of Tanzania, and the US. In that list of only to the specific item being studied. It is important to
participants, it does not include the name of India because note that conducting these specified studies is voluntary
it is not a participant in PMRN. 38 for sponsors. By submitting a pediatric trial request, they

In contrast to the Pediatrics Regulation and the Best can ask for a WR. Any modifications to a WR can only be
Pharmaceutical for Children Act, there is no benefit to made before the sponsor submits the requested studies.
complying with this regulation, leading to the exclusion of The range of conditions to be evaluated in children is
orphan drugs. These drugs are intended for rare conditions wider than those authorized for use in adults or currently
and are exempt from any obligation, which differs from the undergoing approval processes. It encompasses all
earlier pediatrics regulations. Therefore, pediatric research potential benefits of the active ingredient for pediatric
for medications targeting rare diseases (orphans), which patients, regardless of its prior approval status for adults.
are not covered by the PREA, will need to adhere to the Therefore, BPCA regulations in the US permit studies
Best Pharmaceuticals for Children Act (BPCA) process for conditions not included in adult indications, which is
if they were not originally included in the marketing specifically crucial for uncommon and specific pediatric
authorization application (Figure 4). classifications. The BPCA also offers incentives for orphan
5. Summary of laws concerning the categories.
pediatric population To be eligible for these incentives, sponsors must meet
the criteria outlined in the “Guidelines for Industries
5.1. EU Qualification for Pediatrics Exclusion Within Section
In 2007, the pediatric regulation came into effect to make it 505A of the Federal Food, Drug, and Cosmetic Act.”
easier to develop and access medicinal products for children. These guidelines, established in 1999, are presently under
Its goal is to guarantee that children receive therapies that revision. For more information about the WR procedure
are duly authorized. Its goal is to guarantee that children under the BPCA, there are resources available that answer
receive therapies that are duly authorized and to expand common questions related to pediatric exclusivity. It is
the data on the use of these medications across various noteworthy that the FDA will neither award pediatric
pediatric demographics. In the EU, juvenile research has exclusion nor issue a WR for studies submitted to them
been required for all new products since 2007. This also before the issuance of a WR. 39

Volume 7 Issue 4 (2024) 6 doi: 10.36922/itps.3831