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Centre has revoked the ban on the fixed dose combination (FDC) containing APIs - paracetamol+ caffeine+ phenylephrine+ chlorpheniramine through a Gazette notification dated 5 February, 2019 which was earlier prohibited for manufacture, sale and distribution for humans. The FDC was banned as DTAB had recommended it for lack of therapeutic justification for the ingredients contained in the FDC.
The notification said, “In exercise of powers conferred by section 26 A of the drugs and cosmetics act, 1940, the central government hereby rescinds the notification of the Government of India in the ministry of health and family welfare published in the Gazette of India, extraordinary, part II section 3, sub section (ii) vide number S O 4616 (E) dated September 7, 2018 with immediate effect.”
The Central Government had earlier therefore in exercise of powers conferred by section 26 A of the drugs and cosmetics act, 1940 (23 of 1940) prohibited the manufacture, sale and distribution for human use.
In compliance with the directions given by the Supreme Court of India in its judgment dated the 15 December, 2017 in Union of India v/s Pfizer ltd. Civil appeal number 22972 of 2017. arising out of SLP (c) number 7061 of 2017, the matter was examined by Drugs Technical Advisory Board (DTAB) constituted under section 5 of the drugs and cosmetics act, 1940 which furnished its report on 31 July, 2018 in respect of FDC to the Central Government.
Phenylephrine is a sympathomimetic amine that has been available for use as an OTC nasal decongestant since the early 1960s. It is included as a Category I (safe and effective) oral nasal decongestant in the Final Monograph of Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Drug Products for Over-the-Counter Human Use.
Chlorpheniramine, a classical H1-receptor antagonist (antihistamine), has been available for more than 40 years as a nonprescription medication for relief of allergic rhinitis symptoms, and is included as a Category I (safe and effective) antihistamine in the Final Monograph of Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Drug Products for Over-the-Counter Human Use.
This composition has 14 widely used products with manufacturers like Glenmark Pharmaceuticals Ltd, Abbott, Macleods Pharmaceuticals Ltd, Aristo Pharmaceuticals Pvt Ltd, Micro Labs Limited, Green Cross Remedies and Wockhardt.
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