The Ministry of Health and Family Welfare (MoH&FW) on December 28, 2023, issued the Drugs (.....Amendment) Rules, 2023.
The following amendment has been stated:
• In rule 74, which states “Conditions of licence in 82[Form 25 and Form 25F]”, in clause (o), for the words “Good Manufacturing Practices”, the words “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products” shall be substituted.
• In rule 76, which states “Form of licences to manufacture drugs specified in Schedules C and C(l), excluding those specified in 97[Part XB and] Schedule X, or drugs specified in Schedules C, C(l) and X and the conditions for the grant 98 of such licences”, in clause (8), for the words “Good Manufacturing Practices”, the words “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products” shall be substituted.
This notification will come into force from December 28, 2023.
[Notification No G.S.R. 922(E)]
