The Ministry of Health and Family Welfare (“Ministry”) has, in a Notification dated 7th December, 2018, issued the Drugs and Cosmetics (Ninth Amendment) Rules, 2018 (“Amendment Rules”) to amend the Drugs and Cosmetics Rules, 1945 (“Principal Rules”).
The Amendment exempts gelatine capsules from labelling requirements under Rule 127(2) of the Principal Rules wherein the container of a drug containing permitted colour should have the common name of the colour declared on the label.
The Amendment Rules are effective from the date of their publication in the Official Gazette i.e. 7th December, 2018.
Background:
Pursuant to the issuance of the draft of the Amendment Rules, the Ministry had received objections and suggestions from the public. After considering the comments received, the Ministry issued the Amendment Rules.
Source: Ministry of Health and Family Welfare
