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Health ministry approves Allura red colour for pharmaceutical preparations
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Shardul Nautiyal, Mumbai
December 14 , 2020
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The Union health ministry has considered industry recommendation to approve Allura red colour for pharmaceutical preparations for better identification for drug usage compliance and patient convenience.
The same has been permitted in regulated markets including USA, UK, Canada, Australia and Singapore.
According to industry sources, since it is meant for identification purposes and is being approved in regulated markets, it would be the right step from the export perspective also as India supplies medicines to over 250 countries in the world.
Allura Red AC is a coal tar colour which is a red azo dye compound derivative of naphthalene. This term coal tar is an older nomenclature for synthetic chemical that started out with coal tar as the precursor. The colour FD&C Red 40 is a synthetic chemical and is also referred to as coal tar colours. This colour is, however, not included in the list of approved colours as prescribed in rule 127 of the D&C Rules, 1945.
The same has been considered for approval based on Drugs Technical Advisory Board (DTAB) deliberations and recommendations for amending the Rule 127 of the Drugs and Cosmetics (D&C) Rules, 1945 to include FD&C Red # 40 Aluminum Lake (E l29) Allura red colour.
Representation on the same has been received from the industry that currently conjugated estrogen tablets USP are being manufactured by them in a white tablet format using Opadry white as the colouring agent.
Now, the manufacturers want to change the colour coat of conjugated estrogen tablets USP from white to maroon coat utilizing colour pigment FD & C Red # 40 Aluminum Lake (E129) Allura red. The Opadry Maroon colour coat contains HPMC 2910/ Hypromellose [6cP], titanium dioxide, FD&C Red # 40 Aluminum Lake (El29) (Allura red) PEG 400/Macrogol and FD&C Blue #2 Aluminum Lake (El32).
However, the same is approved and used for many years by major regulatory authorities across the world as permitted colour for pharmaceutical preparations and food products. Further, the Food Safety and Standards Authority of India (FSSAI) has also approved FD&C Red # 40 Aluminum Lake (E l29) (Allura red) as colorant in food products in India.
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