Health Ministry Removes Pack Size Provisions for Chest Pain Formulations

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The Ministry of Health and Family Welfare has recently announced an amendment to the Drugs Rules, 1945, regarding the pack size norms of glyceryl trinitrate and isosorbide dinitrate formulations, which are used to treat chest pain. 

The primary objective of the amendment is to aid patients in adhering to the recommended duration of therapy by modifying the pack size guidelines.

The Ministry prepared the draft amendment in September of last year and gave its final approval through the official notification.

The amendment modifies Rule 105 of the Drugs Rules and the Schedule P1 list, specifying pack sizes for certain drug formulations. This amendment became effective from its official publication in the Official Gazette.

The amendment omits glyceryl trinitrate and isosorbide dinitrate formulations from the provisions for pack sizes of drugs under Schedule P1. 

It also modifies the package size requirements of drugs that are not specified in Schedule P1. Pack sizes of more than ten capsules or tablets must now contain several multiples of five and seven capsules.

Previously, Rule 105 of the Drugs Rules stated that pack sizes for tablets/capsules with over ten tablets/capsules must contain multiples of five unless specified otherwise in Schedule P1. 

The amendment changes this requirement to “multiples of five or seven” tablets. Moreover, pack sizes containing less than ten tablets (coated or uncoated) or capsules (hard or soft gelatin) must be made by integral number, according to the Rules.