1 Review Student, Shraddha Institute of Pharmacy, Kondala zambare, Washim, Maharashtra, India - 444505
2 Department of pharmacology, Shraddha Institute of Pharmacy, Kondala zambare, Washim, Maharashtra, India – 444505
Research Article
GSC Biological and Pharmaceutical Sciences, 2025, 33(02), 328–337.
Article DOI: 10.30574/gscbps.2025.33.2.0451
Received on 04 October 2025; revised on 10 November 2025; accepted on 13 November 2025
A number of children died and were hospitalized as a result of upsetting public health concerns regarding pediatric cough syrups in India in 2025. These occurrences brought to light significant pharmacovigilance procedures and regulatory shortcomings. They also underscored the urgent need for reform to enhance medication safety in India, with a particular focus on pediatric formulations. In order to improve medication regulation, manufacturing monitoring, and public health policy in India, this review provides the available data, regulatory reactions, toxicological findings, and lessons learned.
This article's goals are to give a general overview of pediatric pharmacovigilance, illustrate its differences from adult pharmacovigilance, and offer real-world instances.
The Food and Drug Administration in the US has a reputable division dedicated to overseeing the development of pharmaceuticals for children. Similarly, the Central Drugs Standard Control Organization (CDSCO) in India has the authority to impose rules tailored to the production of pediatric medications. There is an urgent need to address the problem and introduce particular drug development guidelines in order to control and safeguard the interests of the pediatric population in light of the planned revisions to India's drug development guidelines.
Pediatric drug safety; Pharmacovigilance; Regulatory oversight; Pediatric formulations; Public health response; Pediatric adverse drug reactions; Drug development guidelines India.
Preview Article PDF
Kartik D. Chavhan, Swati P. Deshmukh and Shivshankar G. Devkunbi. A critical review of pediatric drug safety, Regulatory oversight and public health response in India 2025. GSC Biological and Pharmaceutical Sciences, 2025, 33(2), 328-337. Article DOI: https://doi.org/10.30574/gscbps.2025.33.2.0451