Regulatory Aspect for OTC and Cosmetics products in India and Overseas

Regulatory Aspect for OTC and Cosmetics products in India and Overseas

Hanna Kotru, T. M. Pramod Kumar*, Ramesh Surianarayanan


With the heady optimism surrounding the potentially massive growth of the consumer healthcare segment, much of it justified, come real difficulties. When the pharmaceutical industry cuts out the middle man and sells straight to the customer, the dangers of counterfeiting and the challenges of keeping an eye on a more complicated supply chain arise. Number of drugs going off-patent, and will be free for competitors to replicate. Switching from prescription-only treatments to OTC can be seen as a way for pharmaceutical companies to protect revenues from brands that are soon to lose their patent protection, with the profits from selling a widely recognized product OTC, offsetting the losses caused by losing exclusive rights to produce the drug. The 1938 Food, Drug, and Cosmetic Act brought the cosmetic industry under the regulatory jurisdiction of the FDA. However, the confluence of federal administrative budgetary constraints, historical conditions of the cosmetic industry’s development, and pragmatic policy considerations has fostered a unique regulatory regime. The FDA has come to rely heavily on the cosmetic industry to regulate itself in order to ensure consumer safety. The current regulations of cosmetics are stringent.


OTC Market, Cosmetics, European Market, Switch to OTC drugs, Prescription

Cite This Article

Kotru, H., Pramod Kumar, T. M., & Surianarayanan, R. (2017). Regulatory Aspect for OTC and Cosmetics products in India and Overseas, International Journal for Pharmaceutical Research Scholars, 6(1), 38-52.

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