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.

These claims can only be made by medicines that must be registered under the Drugs Division of CDSCO product labels must not mention words such as treatment as it may attract the definition of Drugs. They can take action against the manufacturer of a cosmetic on the market if they have reliable information to show that a cosmetic does not meet the legal requirement for safety.

The Advertising Standards Council of India (ASCI), established in 1985, is committed to the cause of Self-Regulation in Advertising, ensuring the protection of the interests of consumers.

ASCI’s goals include monitoring, administering & promoting standards of advertising practices in India with a view to:

  • Ensuring truthfulness and honesty of representations and claims made through advertising and safeguarding against misleading advertising.
  • Ensuring that advertising is not offensive to generally accepted norms and standards of public decency.
  • Safeguarding against indiscriminate use of advertising for promotion of products or services which are generally regarded as hazardous to society or to individuals or which are unacceptable to society as a whole.
  • Ensuring that advertisements observe fairness in competition and the canons of generally accepted competitive behaviour.

The Advertising Standards Council of India (ASCI) askedcompanies to ensure that advertisements featuring claims on health benefits, improving disease condition, providing supplementation, beautifying etc. are substantiated with evidence that is backed by recognised health organisations, regulatory-approved clinical research or recognised medical or technical literature.

ASCI states – Advertisers should be able to substantiate (direct or indirect) claims of support by either technical support recognised or approved by health authorities such as WHO, ICMR, Health Ministry, Ayush Ministry, DCGI, CDC (USA), or health organisations of similar stature or by well-recognised medical/technical literature or by regulatory-approved clinical research conducted by a recognised medical institute/laboratory.


ASCI told BusinessLine that the advisory has been formulated after consultation with various technical experts. “ASCI’s code has comprehensive guidelines on misleading ads. Companies are launching new products in response to the evolving needs of consumers. But ASCI want them to ensure that their claims and promises are backed by adequate substantiation to safeguard consumers’ interest.

ASCI releases Guidelines for Celebrities in Advertising


Consumers are becoming more informed, engaged and are raising expectations regarding cosmetics and personal care products. They “invest in themselves” and are ready to pay more, provided products offer specific benefits and visible results.

Most people take quality as the most important factor to purchase a cosmetic product and packaging as the least important factor for purchasing acosmetic product.

NovoBliss Research always recommends to the Manufacturers having claims substantiation safety and efficacy studies or Proof of Science study to back up their products claims and confirmed product safety and efficacy before launching to the Market.

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