The Department of Health and Family Welfare vide notification dated 20th January, 2022 has issued the Drugs (2nd Amendment) Rules, 2022. Liquid Antiseptics for household use is exempted from requirement of sale license in Form 20 or Form 20A, subject to the following conditions, namely:─
(a) The drugs are manufactured by licensed manufacturers;
(b) the drugs do not contain any substance specified in Schedule G, H, H1 or X;
(c) the drugs are sold in the original unopened containers of the licensed manufacturer;
(d) the drugs are purchased from a licensed wholesaler or a licensed manufacturer.
Consultation paper on Maintenance of Record of Mandatory Communication by Regulated Entities
It is proposed that the regulated entities maybe mandated to maintain the record of all such communication, which are mandated to be communicated under the