COSMETICS AS QUASI AND OTC DRUGS

COSMETICS AS QUASI 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 are generally classified into two types:
GROUP 1
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 that includes different kinds of bandage, plastics bandages.
GROUP 2
Odour inhibitors like toothpaste, antiperspirants and bath products.
Hair care 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.
The registration process for quasi drugs is systematic and as few protocols to qualify.
Submission – the data must be submitted to the HA for product approval. Then for the safety and efficacy evaluation of the product will be submitted to the cosmetics evaluation division (CED) and national institute of food and drug safety evaluation (NIFDS). Lastly for the safety and efficacy evaluation it will be handed over to medical products safety division regional food and drug safety.
Review – 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.
Approval/Notification – HA will issue approval and notification both if it qualifies in the Korean pharmacopoeia and other pharmaceutical compendia recognized by the MFDS.

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COSMETICS AS OTC DRUGS
OTC drugs are medicines sold directly to the patients without prescription from healthcare professional .OTC drugs are usually regulated according to the active pharmaceutical ingredient (API),rather then final products. By regulating API instead of drug formulation, government allows manufactures 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.
According to consumer healthcare products association (CHPA) ,73% Americans would rather treat themselves at home than to see a doctor.
Americans buy more the 5 billion OTC drug products each year -60% of drugs used.
ADVANTAGES OF OTC DRUGS
More benefits less risks.
Low misuse and abuse potential.
Consumer are able to self diagnose,self treat,self manage.
Adequately labelled.
Health practitioner are not needed.
DISADVANTAGES OF OTC DRUGS
Reduced opportunities to receive counselling about possible lifestyle therapies.
Poorer compliance.
Misdiagnose patients wont benefit from the drug but will be exposed to its risks.
More difficult to study a drugs effects.