Hello everyone, let us talk about a hot topic of discussion for every start-up manufactures in India – Do we need to go for safety and efficacy trials for cosmetics in India?

The cosmetics market is changing around the globe dramatically.

India is also a large market that was of less interest to major cosmetic manufacturers in the past, probably because of the low average income of the population. However, it is becoming increasingly important considering its economic growth.

Indian cosmetic regulatory framework is completely integrated into drug regulatory framework (its origins dating back to the 1940s). The cosmetics safety, efficacy, regulatory framework and marketing of cosmetics are the key factors of the growth of the cosmetic industry.

India has strict rules and regulations for cosmetic products. According to the Drugs & Cosmetics Act 1940 and Cosmetics Rules 2020, the labels or regulatory artworks of the products are required to be submitted to Central Drug Standard Control Organization (CDSCO) as part of documents for processing of an application for grant of approval.

Regulatory is evolving, so does the regulator himself/herself since 2013 when the regulation came into place the department has been notifying various Amendments. Similar to such changes CDSCO have been on its toes to avoid False or Misleading Claims.

Cosmetics products cannot make therapeutic or medical claims; such as claims for modifying a physiological process or to treat or prevent disease.

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