In furtherance to what we reported earlier (please refer to e-mails in trail), the Ministry of Health has amended the Drugs Rules, 1945. This amendment specifically addresses the packaging regulations concerning tablets (coated or uncoated) and capsules (both hard and soft gelatin). Formerly constrained to multiples of 5, the amendment now permits quantities exceeding 10 to be packaged in multiples of both 7 and 5. Further, Schedule P1, which outlines the dosage forms and pack sizes of specific drugs, has been revised to exclude Glyceryl Trinitrate and Isosorbide Dinitrate from the list.
For further details, please refer to the document attached herewith for your reference.
Source: Ministry of Health and Family Welfare
