Pharmabiz
 

Leading cosmetics co writes to DCGI to relax D&C Rules to approve products with mercury

Shardul Nautiyal, Mumbai Saturday, October 8, 2016, 08:00 Hrs  [IST]

A leading international cosmetics company has written to the Drug Controller General of India (DCGI) to approve cosmetic products having mercury level at 1 ppm following a state drug regulatory authority’s report claiming to have found mercury levels beyond permissible limits in its skin whitening and face wash products.

International cosmetics rules recognise the unintentional presence of mercury due to air and water contact and allow products with mercury at 1 to 3 ppm levels. However, according to the Indian Drugs and Cosmetics Rules, 1945, no cosmetics containing mercury compounds shall be manufactured.

This comes close on the heels of Union health ministry also considering a proposal to amend a rule that currently exempts steroid based skin creams from being labeled as Schedule H drugs during a recent meeting of the Drugs Technical Advisory Board (DTAB) held in Delhi.

Meanwhile, Maharashtra Food and Drug Administration (FDA) has also launched a massive crackdown on manufacturers of steroid-laden skin creams for violating the labeling conditions of the Drug Rules and making false claims of making a person fair.

Manufacturers of such products which have come under the drug regulator’s scanner contain steroids and are recommended to be taken under the supervision of a dermatologist.

The drug regulator has found that these fairness creams which were being sold as OTC drugs have ingredients like hydroquinone, tretinoin, mometasone furoate which are meant to treat skin disorders based on a doctor’s supervision.

According to officials, drugs positioned as fairness creams through companies' advertisements have misled the public with false claims on enhancing skin complexion and treatment.

FDA had earlier detected cases of leading cosmetic brands in the country promoting skin creams as OTC drugs for treatment of skin ailments through self-medication in violation of labeling conditions of the Drugs and Cosmetic Rules, 1945.

 
[Close]