Health ministry to amend Sch H of D&C Rules to curb misuse of certain steroid preparations

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The Union health ministry will soon amend Schedule H of the Drugs & Cosmetics Rules (D&C Rules), 1945 to include certain steroid preparations in Schedule H which are misused mainly as topical steroids leading to extensive Tinea infections.

A decision to this effect was taken by the Drugs Technical Advisory Board (DTAB) of the health ministry, which is considered the highest authority on technical matters under the Union health ministry. The DTAB, in its 77th meeting held on 16th June, 2017 considered a proposal of the ministry to amend Schedule H to include certain steroid preparations which are misused mainly as topical steroids leading to extensive Tinea infections.

After examining the issue in detail, the DTAB recommended for inclusion of several corticosteroids in Schedule H of the Drugs and Cosmetics Rules, 1945. They include alclometasone, beclomethasone, betamethasone, desonide, desoximetasone, dexamethasone, diflorasone diacetate, fluocinonide, fluocinolone acetonide, halobetasol propionate, halometasone, methylprednisone, prednicarbate and triamcinolone acetonide.

Besides, the DTAB also recommended to the ministry to constitute a Standing Committee under chairmanship of Director General of Health Services (DGHS) comprising some of members of DTAB for periodic review of the marketed drugs in respect of their inclusion/deletion in Schedule H of the Drugs and Cosmetics Rule, 1945 and submit the recommendation to DTAB for consideration. The other members of the Standing Committee are The Chair in Clinical Pharmacology, Indian Council of Medical Research (ICMR); The President, Pharmacy Council of India (PCI); The President, Medical Council of India (MCI); and one in-charge of Drugs Controller in the States nominated to be member of DTAB.

Dr. Jagdish Prasad, Director General of Health Services (chairman); C. Hariharan Director in-charge, CDL, Kolkata; Dr. A. K. Tahlan, Director, CRI, Kasauli; Dr. P. Dhar, Indian Veterinary Research Institute, Izatnagar, UP; OS Sadhwani, Joint Commissioner, FDA, Maharashtra; Dr. B.Suresh, President, PCI; Dr.H.G.Koshia, Commissioner, FDCA, Gujarat; Dr.Nilima Kshirasagar, Chair in Clinical Pharmacology, ICMR; Prof. MD Karvekar, Bangalore; Dr. Rao V. S. V. Vadlamudi, President, Indian Pharmaceutical Association Hyderabad; Sudhir Mehta, chairman, Torrent Pharmaceuticals, Dr. G. N. Singh, DCGI (Member Secretary); President, Medical Council of India; Director, CDRI, Lucknow; Shushma Saptarshi, Asst. Director & Government Analyst, Drugs Control Laboratory, Mumbai; Dr. G. B. Gupta, Prof. And Head, Department of Medicine, Raipur; Dr. A Marthanda Pillai, Ananthapuri Hospital and Res. Institute, Kerala; and Sheju Purushothaman, Government Analyst, Regional Drugs Testing Laboratory, Kerala are the members of the DTAB.

Source: 1

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