On November 11, 2017 the Central Government proposed to make amendments to certain Drugs and Cosmetics Rules, in exercise of the powers conferred to it, by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in consultation with the Drugs Technical Advisory Board. The Central Government has published the draft rules, and notified to all the persons likely to be affected thereby, that the draft rules will be taken into consideration on or after the expiry of a period of forty-five days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.
Further, the proposed draft rules may be called the Drugs and Cosmetics (........Amendment) Rules, 2017 and shall come into force on the date of their final publication in the Official Gazette.
In Drugs and Cosmetics Rules, 1945, in Schedule H, after the serial number 537, following 14 new entries, with corresponding serial numbers given below, shall be inserted:
- 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.1,2
These amendment/entries in schedule H were proposed after concerns were raised by the Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) to the office of Drug Controller General India (DCGI) regarding
- The adverse effects induced by rampant misuse of creams containing corticosteroids along with antibiotics and antifungals causing damage to the skin of Indian citizens.
- Increasing number of cases of Topical Steroid Damaged Face (TSDF) and steroid modified recalcitrant and/or extensive tinea (fungal infection of the skin known as ringworm) have come to the notice of the dermatologists.
- These creams are purchased and used by the patients without any doctor's prescription as Schedule H provided exemption for topical or external use preparations from the purview of Schedule H and H1, in the note appended to these Schedules3.
Note- DCGI also notifies, if there are any related objections or suggestions, the matter may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India within stipulated time.
Footnotes
1. http://cdsco.nic.in/writereaddata/77th%20DTAB%20Minutes%20with%20approval%20letter.pdf
2. http://www.egazette.nic.in/WriteReadData/2017/179978.pdf
3. http://www.cdsco.nic.in/writereaddata/redtab71st.pdf
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