Last Updated on January 6, 2024 by The Health Master
The Union health ministry has amended the notification dated July 23, 1983 and has finally approved the fixed dose combination (FDC) of tamsulosin HCI + deflazacort for asthma therapy.
As per Union health ministry notification, “Union health ministry has approved to exclude the FDC of tamsulosin HCI 0.4 mg (as film coated modified release tablet) + deflazacort 30mg hard gelatin capsule from the prohibition made via notification dated October 9, 2009 through an amendment of the said notification number G.S.R. 578(E), dated July 23, 1983 and substituted item 14 and the entries relating thereto with the entry “Fixed dose combination of corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers”.
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Notification dated July 23, 1983 prohibited the manufacture and sale of FDCs of steroids for internal use except combination of steroids with other drugs for the treatment of asthma.
The Central government had earlier also vide notification dated October 9, 2009 amended the said notification dated July 23, 1983 and substituted item 14 and the entries relating thereto with the entry “Fixed dose combination of corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers.”
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Now therefore, in exercise of the powers conferred by Section 26A of the Drugs and Cosmetics (D&C) 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:—
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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 0.4mg (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.”
FDC of tamsulosin HCI 0.4 mg (as film coated modified release tablet) + deflazacort 30 mg hard gelatin capsule was also examined by Prof. Kokate Committee constituted by the Central government for examining the safety and efficacy of FDCs which were licensed prior to October 1, 2012 without prior approval of the Central Licensing Authority (CLA).
Therefore, Prof. Kokate Committee examined the said FDC in current scenario based on the available documents and scientific literature and considered this FDC as rational and accordingly, the FDC of tamsulosin HCI 0.4mg (as film coated modified release tablet) + deflazacort 30 mg hard gelatin capsule was approved.
FDC of tamsulosin HCI 0.4 mg (as film coated modified release tablet) + deflazacort 30 mg hard gelatin capsule was then referred to Drugs Technical Advisory Board (DTAB) and upon examination, the DTAB has recommended to exclude the FDC of tamsulosin HCI 0.4 mg (as film coated modified release tablet) + deflazacort 30 mg hard gelatin capsule from the prohibition made vide notification number G.S.R.738 (E), dated October 9, 2009.
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