Govt to amend Drugs Rules to allow Allura Red colour to be used in medicines

New Delhi: Issuing a draft rules the central government has proposed to insert Allura Red which chemical name is Disodium 6-hydroxy-5-[(2-methoxy-5-methyl-4- sulfophenyl)azo]-2-Naphthalenesulfonic acid as Coal Tar Colours to be used in drugs.

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.

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.

In order to amend the Drugs Rules, 1945, the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to public.

In addition, the notice stated that objections and suggestions which may be received from any person within the period specified will be considered by the Central Government.

"Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in." the notice added.

As per the issued notice, the draft rules stated,

"1. (1) These rules may be called the Drugs (…..Amendment) Rules, 2021.

      (2) These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.

2. In the Drugs Rules, 1945, in rule127, 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:—