The Ministry of Health and Family Welfare (MoHFW) on March 18, 2024, issued the Drugs (Second Amendment) Rules, 2024 to further amend the Drugs Rules, 1945.
The following has been stated namely: -
• Rule 105 which states “Packing of drugs” in sub-rule (2), in clause (i), the following has been substituted namely: -
“Where the number of Tablets (coated or uncoated)/Capsules (hard or soft gelatine) is less than 10, such packing shall be made by the integral number. For numbers above 10, the pack sizes of Tablets/Capsules shall contain multiples of 5 or 7”
• In the principal rules, in Schedule P1, under the heading “PACK SIZES OF DRUGS”, the drugs “Glyceryl Trinitrate” and “Isosorbide Dinitrate” mentioned in column 1 and entries relating thereto in columns 2 and 3 shall be omitted.
This shall come into force on March 18, 2024
[Notification No. G.S.R. 216(E)]
