Cosmetovigilance in India: Industry Expert Perspective

ABSTRACTMany cosmetic and cosmeceutical products and brands are available in the Indian market. The number of new and innovative cosmetic product categories available in India are on the rise for last two decades. The cosmetic industry ranges from local small-scale businesses to multi-crore international branded ventures. Most of the local ones are often not under any rules or regulations. There is a dearth of research on cosmetovigilance despite the growing popularity and demand for cosmetic items among consumers of cosmetics. “The term “cosmetovigilance” refers to the processes involved in assessing and keeping track of unprompted reports of unfavorable outcomes during or following regular or reasonably anticipated use of a cosmetic product.”Objective: The purpose of the study is to understand the cosmetovigilance system from industry experts’ perspectives with special reference to regulatory aspects in the Indian context.Method: This is a cross-sectional qualitative and quantitative study; the data was collected through a structured questionnaire and through a questionnaire guide from selected industrial regulatory experts (targeted respondents). The purposive sampling and convincing methods were used for the study. Descriptive statistics were used to analyze the data.Result: Around 73% of regulatory experts said that companies should follow the regulatory guidelines for ensuring the safety and labeling of cosmetics. Around 66.6% responded that they have not come across any ACE reporting form by CDSCO. From the point of view of consumer safety, the establishment of cosmetovigilance practises and a reporting form is essential. Nevertheless, the companies try their best to control the safety aspects of cosmetic products.