Govt to amend Drug Rules for list of colours permitted to be used in Drugs

Download notification No. GSR 840(E) dt 29-11-2021

Govt of India

Last Updated on December 4, 2021 by The Health Master

Download notification No. GSR 840(E) dt 29-11-2021: The Central government is planning to allow Allura Red, used in cereal, beverages and some of the other food products, to be used in drugs.

The product is allowed to be used in foods, pharmaceuticals, and cosmetics by regulators in various regulated markets.

The ministry of health and family welfare has issued a draft notification No. GSR 840(E) dt 29-11-2021 proposing an amendment to the Drugs Rules, 1945, to add Allura Red to the list of colours permitted to be used in drugs.

The draft rules propose to insert Allura Red (colour index 16035), with chemical name disodium 6-hydroxy-5-[2-methoxy-5-methyl-4-sulfophenyl)-2-naphthalenesulfonic acid, in rule 127, in sub-rule 1 under the heading three relating to ‘Coal Tar Colours’.

The entry will be inserted under the colour Red after the entry ‘Carmoisine’ and before the colour Blue, which starts with ‘Indigo Carmine’, according to the draft notification.

The Drug Rules had earlier allowed Fast Red in this place, which was later omitted by the ministry on November 4, 1999.

The list of colours permitted to be used in drugs includes natural colours such as annatto, carotene, chlorophyll, cochineal, curcumin, red oxide of iron, yellow oxide of iron, and artificial colours like caramel and riboflavin.

Under the Coal tar colours, colours including green, yellow, red, blue, orange, brown and black produced from certain chemicals listed in the Rules, are allowed to be used in drugs. No drug shall contain a colour other than specified under this rule 127, of the Drugs Rules, 1945.

According to the US-based International Association of Color Manufacturers (IACM), founded by the association representing the interests of the colour additives industry, both natural and synthetics as well as the colour user community, allura red is an orange red dye that has a red to brownish share in applications.

“Allura red is used in cereal, beverages, gelatins, puddings, dairy products, frozen treats, powder mixes, icings, jellies, spices, dressings, sauces, baked goods and confections. FD&C Red No.40 is also used in pharmaceuticals and cosmetics,” it added.

It is added to foods and beverages at concentrations up to a maximum permitted level in more than 50 food categories as established by the Codex Alimentarius Commission and published in the General Standard of Food Additives (GSFA), added the Association.

The colour has regulatory approvals from the United States, European Union and by the Joint FAO/WHO Expert Committee on Food Additives.

The draft amendment rules have been published in the Gazette of India after consulting with the Drugs Technical Advisory Board, for information of all persons likely to be affected.

The notice has also been given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirdly days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.

Objections and suggestions that may be received from any person within the period specified will be considered by the Central government.

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