Health Ministry nod to Tamsulosin HCL, Deflazacort FDC for treating Asthma

The notification declared that the fixed-dose combination (FDC) of Tamsulosin HCI 0.4 mg (as a film-coated modified-release tablet) and Deflazacort 30mg in hard gelatin capsule will be withdrawn from the list of medicines that are banned for manufacture and sale.

This came after the Kokate Committee and the Drugs Technical Advisory Board both declared the said FDC to be rational and should be exempted from the prohibition imposed by notification number G.S.R. 738 (E), dated October 9, 2009. As per the notification, fixed-dose combinations of corticosteroid with any other drug for internal use, except preparations intended for meter dose inhalers and dry powder inhalers, are prohibited.

Previously, the Central Government prohibited the manufacture and sale of FDCs of Steroids for internal use, except for the combination of Steroids with other drugs for the treatment of Asthma, via notification number G.S.R. 578 (E), dated July 23, 1983, which was later amended via notification number G.S.R. 738 (E), dated October 9, 2009, and prohibited the manufacture and sale of FDCs of Steroids for internal use except for preparations meant for meter dose inhalers and dry powder inhalers.

The Tamsulosin and Deflazacort combination contains two medicines, the alpha-blocker Tamsulosin and the glucocorticoid Deflazacort. This formulation is indicated to treat kidney stones. Tamsulosin works by relaxing the muscle around the bladder exit and prostate gland so as to allow easy passage of urine, while Deflazacort is a steroid medicine that works by reducing inflammation (swelling) in the kidneys to promote the passage of the stones through urine.

In order to decide the fate of the said FDC, Prof. Kokate committee, which was formed by the Central Government to examine the safety and efficacy of FDCs licensed prior to 1st October 2012 without prior approval of the Central Licensing Authority, examined the said FDC in the current scenario based on available documents and scientific literature and considered the FDC to be rational and effective.

Furthermore, the said combination drug was also referred to the Drugs Technical Advisory Board (DTAB) and, upon examination, the Drugs Technical Advisory Board had recommended excluding the FDC of Tamsulosin HCI 0.4 mg (as a film-coated modified-release tablet) + Deflazacort 30 mg hard gelatin capsule from the list of medicines that are prohibited for manufacture and sale.

Macleod's Defcort TM Tablet, Alkem's Tamsukem Plus Capsule PR are some of the well-known brand names for the said fixed-dose combination drug.

Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following amendments further to amend the notification number G.S.R. 578(E), dated the 23rd July 1983, namely: —

In the notification, in the Table, for item 14 and the entries relating thereto, the following item and entries shall be substituted, namely:—

"14. Fixed Dose Combination of corticosteroid with any other drug [excluding Fixed Dose Combination of Tamsulosin HCI 0.4 mg (as film coated modified release tablet) + Deflazacort 30mg in hard gelatin capsule] for internal use except for preparations meant for meter dose inhalers and dry powder inhalers.".

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