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Government Amends The Use Of Corticosteroids In Medical Inhalers

Kokate Committee established by the Central Government for scrutinizing the safety as well as efficiency of FDC, which was licensed before October 1, 2012, without previous approval of the central licensing authority according to the drug license application process.

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Government Amends The Use Of Corticosteroids In Medical Inhalers

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  1. Government Amends The Use Of Corticosteroids In Medical Inhalers The union health ministry has revised the notification dated July 23, 1983, and has approved the fixed-dose combination of Tamsulosin HCl and Deflazacort for asthma therapy. As per the notification by the union health ministry, "The Union Health Ministry has given approval to exclude the FDC of Tamsulosin HCl 0.4mg + Deflazacort 30mg hard gelatin capsule from the prevention made through notification date October 9 2009. Contact No: +91 7672005050 Email: contact@cliniexperts.com

  2. It has been made through an amendment of the notification number GSR 578 (E) dated July 23.1983 and substituted item 14 and the entries thereto along with the entry '' Fixed-dose missing of corticosteroid with any other kind of drug for internal use other than the preparation required for metered dose inhalers as well as dry powder inhalers. The notification dated July 23, 1983, prevented the manufacture and sale of FDCs of steroids for internal use other than a combination of the steroids with other drugs for asthma treatment. To exercise the powers deliberated by section 26A of the Drugs and Cosmetics Act 1940, the central government, after prior consultation with the Drugs Technical Advisory Board, made the amendment further to modify the notification number GSR 578 euro dated July 23. Contact No: +91 7672005050 Email: contact@cliniexperts.com

  3. FDC of Tamsulosin HCl 0.4mg + Deflazacort 30mg hard gelatin capsule was also monitored by Prof. Kokate Committee established by the Central Government for scrutinizing the safety as well as efficiency of FDC, which was licensed before October 1, 2012, without previous approval of the central licensing authority according to the drug license application process. Because of this, Prof. Kokate Committee scrutinized the proposed FDC in the existing scenario depending on the available documents and scientific literature and take into consideration this FDC as a retinal and thus, the FDC of Tamsulosin HCl 0.4mg + Deflazacort 30mg hard gelatin capsule from the prohibition made through notification number GSR 738 dated October 9, 2009. Use to know more information, visit - Drug licence registration process | Drug license consultants for importers Contact No: +91 7672005050 Email: contact@cliniexperts.com

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