Post marketing studies for safety, tolerability, and effectiveness of Himalaya’s comprehensive range of baby care products

Surender Singh Bisht; Mohit Poddar; Jaiprakash Narayan; Akash Harakchand; Diganta Barman; Veerabhadra Mallad; Rajesh Kumawat

doi:10.18203/2349-3291.ijcp20252217

Authors

Surender Singh Bisht Department of Pediatric, SDN Hospital, Delhi, India https://orcid.org/0000-0002-1825-0097
Mohit Poddar Department of Pediatric, NIMS Medical College, Jaipur, Rajasthan, India https://orcid.org/0009-0003-9493-9632
Jaiprakash Narayan Department of Pediatric Medicine, J. L. N. Medical College, Ajmer, Rajasthan, India https://orcid.org/0000-0001-6046-5430
Akash Harakchand Department of Pediatric Neurology, Sir J. J. Group of Hospitals, Mumbai, Maharashtra, India https://orcid.org/0000-0003-1359-2706
Diganta Barman Department of Pediatric Medicine, Marwari Hospital, Guwahati, Assam, India https://orcid.org/0009-0007-3838-5363
Veerabhadra Mallad Department of Pediatric Medicine, Sarv Advanced Multispecialty Clinic and Diagnostic Centre, Bengaluru, Karnataka, India https://orcid.org/0009-0006-2252-3816
Rajesh Kumawat Medical Services and Clinical Development, Himalaya Wellness Company, Bengaluru, Karnataka, India https://orcid.org/0000-0001-9304-646X

DOI:

https://doi.org/10.18203/2349-3291.ijcp20252217

Keywords:

Baby care products, Gentle, Mild, Moisturization, Smoothness, Softness

Abstract

Background: The baby care product market has seen a substantial growth in the recent years which has resulted in an increased concern about the safety and tolerability of these products for babies aged 0-36 months. Due to their delicate skin, the infants are highly sensitive to the potential undesirable effects of chemicals present in such products. This study is conducted with Himalaya’s range of baby care products. To assess safety, tolerability and effectiveness of natural baby care products for newborns, infants and toddlers.

Methods: These post marketing observational studies (PMOS) were conducted among 9000 babies (approx. 500 babies were allocated to each of the 18 products), enrolled at 25 different medical centres across India. Safety, tolerability and efficacy of Himalaya’s range of baby products were assessed after 15 days of usage. Mildness and gentleness of the products on babies’ skin was assessed through dermatological assessment by a pediatrician on the scale of 0-4 (0=No change and 4=excellent). The safety was assessed by continuous monitoring of any signs or symptoms of local intolerance, undesirable effects, and adverse events. Subjective assessments from parents/ caretakers were also recorded to know the tolerability and overall suitability of the test products.

Results: The study ensured the ability to evaluate both the improvement of symptoms from the initial baseline and the potential reappearance of symptoms throughout the research period. The products showed, statistically significant improvement (p value of<0.05) in the softness and smoothness of baby’s skin along with keeping the skin moisturized. No product related local intolerance, undesirable effect or adverse events were observed or reported during the study.

Conclusions: Himalaya's range of baby care products are well-tolerated and found to be safe, effective, and suitable for regular use in babies aged 0 to 36 months.

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