Is hydroquinone banned in India?

Hydroquinone lightens skin by blocking melanin production. In India it is treated as a drug, not a cosmetic. A 2018 amendment to the Drugs and Cosmetics Rules extended the Schedule H entry for topical steroids to cover hydroquinone, with effect from 1 Apr 2019; from that date a cream containing it may be sold at retail only against a registered medical practitioner's prescription. The over-the-counter sale that had made 'fairness creams' with hydroquinone a pharmacy staple ended.

The reason is well documented. Used for months without supervision, hydroquinone can cause exogenous ochronosis, a blue-black pigmentation that is far harder to treat than the dark patches people start with. The problem is worse in the triple-combination creams that pair it with tretinoin and a potent steroid such as mometasone; those creams thin the skin and cause rebound pigmentation when stopped. Both other ingredients are Schedule H as well.

Enforcement shows what the rule catches. In January 2024 Telangana's drugs control administration seized a 'Fair & Bright' cream containing hydroquinone, tretinoin and mometasone and sold with a skin-lightening claim, which Schedule J prohibits for a drug. CDSCO's October 2024 alert lists Lumadip, a hydroquinone-tretinoin-allantoin cream, as not of standard quality. And the Cosmetics Rules 2020 do not permit hydroquinone in a cosmetic at all, so any 'fairness cream' sold as a cosmetic with it is an unlicensed drug.