Govt allows Allura Red as colour to be used in medicines

Allura red is a monoazo dye that is widely used as a synthetic food color in many countries around the world.

Allura red is principally the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid which is an orange red dye that has a red to brownish shade in applications.

Allura Red is usually supplied as its red sodium salt, but can also be used as calcium and potassium salts. These salts are soluble in water.

By products of the petroleum industry are used to produce Allura Red. It is manufactured by coupling diazotized 5-amino-4-methoxy-2-toluenesulfonic acid with 6-hydroxy-2-naphthalene sulfonic acid.

Earlier, the Medical Dialogues Team had reported that the government had proposed a draft to insert Allura Red as a coal tar colour to be used in drugs and other pharmaceutical products.

Colors such as green, yellow, red, blue, orange, brown, and black produced from certain chemicals listed in the rules are permitted to be used in drugs under the coal tar rules. No drug shall contain a colour other than that specified in Drugs Rules, 1945, Rule 127, according to the Drug Rule.

Now in continuation, the recently issued gazette notification stated that a draft of certain rules further to amend the Drugs Rules, 1945, was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 840(E), dated the 29th November, 2021, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public.

Further, the notice added that copies of the said official gazette were made available to the public on November 29, 2021, and accordingly, objections and suggestions received from the public on the said draft rules have been considered by the Central Government.

Therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, has made the following rules further to amend the Drugs Rules, 1945, namely:

(A) 1. These rules may be called the Drugs (3rd Amendment) Rules, 2022.

2. They shall come into force on the date of their publication in the Official Gazette.

(B) In the Drugs Rules, 1945, in rule 127, in sub-rule (1), under the heading (3) relating to „Coal Tar Colours‟, after the entry „Carmoisine‟ and before the entry „BLUE Indigo Carmine‟, the following entry shall be inserted, namely: