Cosmetics as quasi and OTC drugs
Quasi-drugs are one of the primary categories of beauty products in South Korea. The other category of beauty products is cosmetics. There is a thin line between drugs and cosmetics, which can be considered as quasi-drugs. Since their benefits are not as suitable as drugs: South Korea’s health authority (HA) and the ministry of food and drug safety (MFDS) has categorized them under skincare products like acne for skin dullness.
Quasi-drugs include Oxidative hair dyeing products, hair waving or straightening products, depilatories, breath fresheners, deodorant products, talcum powder, anti-dandruff products, products to prevent melanin spots and freckles, and so on.
Quasi-drugs are generally classified into two types:
Items used for sanitary purposes such as sanitary pads, tampons and menstrual pads
The textiles used for manufacturing masks such as dust and surgical masks.
Wet wipes for oral hygiene.
Sanitary products used for protection, preservatives, and treatment of affected areas include different kinds of bandages, plastic bandages.
Odour inhibitors like toothpaste, antiperspirants and bath products.
Haircare products that are only meant for external usage.
Products that don’t contain nicotine for those who smoke.
Ointments and anti-inflammatory products for external use.
Time needed: 30 days
The registration process for quasi-drugs
The data must be submitted to the HA for product approval. Then the safety and efficacy evaluation of the product will be submitted to the cosmetics evaluation division (CED) and the national institute of food and drug safety evaluation (NIFDS). Lastly for the safety and efficacy evaluation, it will be handed over to the medical products safety division regional food and drug safety.
After HA receives the safety and efficacy evaluations they will review the specifications. Meanwhile, they will also inspect the manufacturing sites to assess the condition and quality of the production.
HA will issue approval and notification both if it qualifies in the Korean pharmacopoeia and other pharmaceutical compendia recognized by the MFDS.
Cosmetics as OTC Drugs
OTC drugs are medicines sold directly to patients without prescription from a healthcare professional.OTC drugs are usually regulated according to the active pharmaceutical ingredient (API), rather than final products. By regulating API instead of drug formulation, the government allows manufacturers the freedom to formulate ingredients.
Similarly, cosmetic products can be considered as OTCs. Some products meet the definitions of both cosmetics and drugs. Certain claims may cause a product to be considered a drug, even if the product is marketed as a cosmetic.
OTC products compliant with the OTC drug monograph may be marketed without prior FDA approval.
For example, in the U.S antidandruff shampoos and sunscreen products are considered to be OTCs.
OTCs must be manufactured and controlled in accordance with cGMP requirements for pharmaceuticals for human consumption.
ADVANTAGES OF OTC DRUGS
More benefits fewer risks.
Low misuse and abuse potential.
Consumers are able to self diagnose, self treat, self manage.
Health practitioners are not needed.
DISADVANTAGES OF OTC DRUGS
Reduced opportunities to receive counselling about possible lifestyle therapies.
Misdiagnosed patients won’t benefit from the drug but will be exposed to its risks.
More difficult to study the effects of a drug.
Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise