A Cross-Sectional Study on Cosmetovigilance in India: From the Dermatologist’s Perspective

Dear Editor, “Cosmetovigilance is a term used for the activities related to the collection, evaluation and monitoring of spontaneous reports of undesirable events observed during or after normal or reasonably foreseeable use of a cosmetic product”. Vigan et al. and Castelain et al.[1] were the first to use it in the literature (1997). The cosmetovigilance system for cosmetics was established by the French health products safety agency. Some counties like China, South Korea and Taiwan have introduced the cosmetovigilance system. Though India lacks this at present, a formal cosmetovigilance system is the need of the hour for India. In formal cosmetovigilance systems, the regulatory agencies are in charge of gathering side effects of cosmetics (ACRs) reported by various professional categories, such as medical professionals, general practitioners and public health services.[2] As dermatologists play crucial role in advising or prescribing cosmeceutical/cosmetics products their experiences, views and suggestions become significant in the development of the cosmetovigilance system. This is the qualitative, cross-sectional study. Primary data were obtained with the help of structured questionnaire using Google Forms. The Institutional Ethics Committee (IEC) granted ethical approval (IEC No: 585/2020). A sample of 30 dermatologists were selected for deploying the questionnaire with selection criteria includes the dermatologists from South India who had more than 1 year of clinical practice experience in dermatology. Based on convenience of approach, we have chosen the participants. When surveys were not returned within a present time frame, two staged reminders were sent. Data analysis: Analysis was purely a descriptive data. A questionnaire was deployed to 30 dermatologists, and a total of 25 (83.3%) responses were obtained. Figure 1 found that around 20 (80%) dermatologists responded that they are not aware about the concept of cosmetovigilance system. Around 19 (76%) dermatologists said that the concept to cosmetovigilance is not popularized in India. Majority of the dermatologists (96%) responded that implementation of cosmetovigilance system in India can boost the confidence of safe use of the products. This study found that 80% of dermatologists have not reported adverse cosmetics events in patients.Figure 1: Concept on cosmetovigilanceProposed Adverse Cosmetic/Cosmeceutical Events Reporting Form for Healthcare Professions in India [Table 1]Table 1: Proposed adverse cosmetic/cosmeceutical events reporting formWhat to report Serious adverse events should be reported. The reaction is serious when the patient’s outcome is life threatening, death, hospitalization, disabilities etc. Nonserious adverse events also need to be reported. Who can report? All health care professionals can report the adverse reactions within 7 calendar day. Where to report? Adverse reaction monitoring centre (AMC) should be present in each district. Health care professionals need to report the adverse events to AMC or to the regulatory authorities (CDSCO). Health care professionals can call to the toll-free number to report the adverse events. Finally, the regulatory authorities need to take the strict action against recall of that products or cancellation of product.[3] In our study, most of the dermatologist have not reported the side effects due the absence of reporting system, so it is better to develop an adverse event reporting system in India. Any physician can report to PvPI by his own without even contacting the AMC; this initiation can help the society to overcome from the incident of adverse events. Our study found that cosmetovigilance in India is not popularized. It should be thought in detail to the health care provider so that the adverse events can be minimized. Few countries have attempted to implement the adverse reporting system related to cosmetic/cosmeceutical products. Cosmetovigilance system in various countries Europe: According to the EU Cosmetics Regulation (EC) No. 1223/2009, companies are required to compile and evaluate reports of harmful effects on consumers’ health due to the cosmetic items they sell. Unwanted consequences must be informed to the national authorities.[4] Canada: The Natural Health Products (NHP) Regulations, which came into effect in January 2004, urge both patients and healthcare professionals to report any unwanted ADR. Within 15 days of the ADR, the occurrence must be reported.[4] United States: The FDA encourages consumers, businesses and healthcare workers to report adverse drug reactions (ADRs) associated with cosmetics. Through MedWatch, ADRs can be reported to the FDA by contacting the hotline or submitting an online form.[5] Well-organized adverse events reporting form should be created for Indian context. Adverse events reporting form should be available to all, especially in online portals, and at hospitals and clinics. It should be easy to fill and in simple language. Family medicine doctors and other primary care providers are crucial in identifying ADRs brought on by cosmetic items and enticing people to report them, and appropriate action should be initiated towards a report. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

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