The Ministry Of Health And Family Welfare (MoHFW) on May 23, 2022 has issued the draft Drugs (... Amendment) Rules, 2022 to further amend the Drugs Rules, 1945.
The following amendments have been made:
• In rule 75, which specifies Forms of application for licence to manufacture for sale or distribution of drugs specified in Schedules C and C, sub-rule 3A, has been inserted, namely:
“(3A) The application,—
(a) referred in sub-rule (3) of rule 75 of these rules, or
(b) for grant of permission to manufacture new drug for sale or distribution under rule 80 of the New Drugs and Clinical Trials Rules, 2019, or
(c) rule 122B of these rules,
as the case may be made simultaneously.”
• In rule 75, which specifies Forms of application for licence to manufacture for sale or distribution of drugs specified in Schedules C and C, sub-rule (6) has been substituted, namely:
“Where an application under these rules is for the manufacture of drug formulation falling under the purview of new drug under rule 80 of the New Drugs and Clinical Trials Rules, 2019 or rule 122B of the Drugs Rules, 1945, as the case may be, the licence to manufacture for sale or distribution of the drugs shall be granted after approval of the drug as new drug.”
All persons likely to be affected thereby, and notice is hereby given that the said draft rules will 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 the public.
Objections and suggestions which may be received from any person within the period specified above 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. 437, C Wing, Nirman Bhavan, New Delhi - 110011 or emailed at [email protected].
[Notification No. G.S.R. 382(E)]
