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DCGI asks cosmetics industry to follow regulatory protocol, avoid making ’unusual claims’; importers complain

New Delhi: The Drugs Controller General of India (DCGI) has directed the cosmetics industry to follow regulatory protocols, and warned against making “unusual claims” to younger-looking skin that overlap the pharmaceutical sector.

Cosmetics fall under the purview of the Drugs & Cosmetics Act, which has stringent norms.

In a meeting held with the cosmetics industry, stakeholders appealed for easing strict regulatory protocols for imported products. They said most imported cosmetics are being rejected at ports for not complying with the standards laid down by the drug regulator, causing huge financial losses to importers.

“The meeting was organized to discuss the issues that cosmetic industry is facing. Generally, cosmetics have always been under the Drugs and Cosmetic Act. Importers are having issues related to products approval. The regulatory protocol is much easier in other countries. The importers are demanding regulatory procedures to be eased to prevent their financial losses,” said an official aware of the matter, adding that quality and safety of cosmetics products must be ensured.

Cosmetics, as per the law, are defined as any article “intended to be rubbed, poured, sprinkled or sprayed on, applied on human body for the purpose of cleansing, beautifying, promoting attractiveness or altering the appearance”, and includes any article “intended for use as a component of cosmetic”. 

A growing market

According to industry data, cosmetic market in India was valued at $8.1 billion in 2023 and is expected to reach $18.4 billion by 2032.

According to the government specified rules, if the manufacture, sale or distribution of a cosmetic is prohibited in the country of origin, it cannot be imported for sale in IndiA.

“The other issue with cosmetics is overlapping some claims. For example, serum and biologicals or stem cell therapy are being used for younger-looking skin or rejuvenation which is overlapping with drugs,” the official said. 

Queries sent to the health ministry spokesperson remained unanswered. 

“The industry faces challenges due to the complexity of the regulatory environment. The coexistence of multiple laws and authorities can lead to confusion and delays in compliance. Additionally, the absence of clear and consistent regulatory standards creates uncertainty among industry players, complicating adherence to compliance requirements,” said Dr Chytra V. Anand, Cosmetic Dermatologist & Founder of Kosmoderma Clinics and SkinQ.

“Simplification of regulatory processes, clear guidelines and standards, support for innovation and enhanced collaboration is required,” he added.


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