14 steroid-based creams and ointments under the Schedule-H category

14 steroid-based creams and ointments under the Schedule-H category

March 23rd  2018 GSR 277(E)

To prevent the indiscriminate sale of topical preparations containing steroids and antibiotics without prescription, the Health Ministry has banned over-the-counter sale of around 14 such creams.

In a notification issued on March 23, the ministry has put 14 steroid-based creams and ointments under the Schedule-H category by making amendments to certain Drugs and Cosmetics Rules, 1945.

The decision was taken following consultation with the Drugs Technical Advisory Board (DTAB) which had recommended a ban on the sale of such creams without prescription and had also submitted their recommendations to the Central Drugs Standards Control Organisation (CDSCO).

The move come after dermatologists complained that pharmaceutical companies were selling steroid- based creams and ointments to patients who use them without medical guidance.

The revised rules will apply to skin creams that contain steroids or other prescription drugs and not for ordinary face-cleansing and moisturizers.

 These 14 steroids has been added to Schedule H:

In the Drugs and Cosmetics Rules, 1945, in Schedule

H, after serial number 537 and the entries relating there to the following serial numbers and entries shall be inserted, namely,-

“538. Alclometasone

539. Beclomethasone

540. Betamethasone

541. Desonide

542. Desoximetasone

543. Dexamethasone

544. Diflorasone diacetate

545. Fluocinonide

546. Fluocinolone acetonide

547. Halobetasol propionate

548. Halometasone

549. Methylprednisone

550. Prednicarbate

551. Triamcinolone acetonide