Category Archives: RCT

Cosmetics (Photo credit: My Sight, as You See.)

Should the cosmetic industry be regulated? Cosmetic industry historically is either not regulated or the regulations are minimal and ineffectual in most parts of the world. A topical pharmaceutical product takes years to reach the market after stringent safety and efficacy tests on humans and animal models. Still pharmaceutical products cannot advertise while the cosmetic industry can make horrendous claims like 2 shades lighter skin and “get your hair back in 15 days”!

English: Sun Spray, Nature Cosmetic, Sun Spray from Germany Deutsch: Sonnenspray, Naturkosmetik, Deutsches Sonneschutzmittel (Photo credit: Wikipedia)

Ironically most consumers believe that cosmetic products have to substantiate their safety and efficacy to regulatory bodies before they make these claims. But the fact of the matter is, you can get away with normal clay packed in an attractive bottle as a fairness cream. If you have a good advertising team, you can make money too. Some claim “medical” benefits and call themselves cosmeceuticals!

Pharmaceutical products go through pre-clinical Phase I testing on animal models and clinical Phase II and Phase III testing to establish its pharmacokinetic and pharmacodynamic profile. Further monitoring and testing is done in Phase IV for which the gold standard is Randomised Controlled Trial (RCT). RCT is used to compare the product to placebo or the existing standard treatment. Though there is some merit in the argument that Phase I-III tests may not be required for cosmetics as only “products generally considered safe” are used in the manufacturing process, evidence collected through an appropriately conducted RCT is imperative to substantiate any advertisement claims that cosmetic manufacturers make. Manufacturers may not follow Good Manufacturing Practices (GMP) too.

It is high time for fairness creams to play fair!