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Health ministry removes pack size provisions for two chest pain formulations from Schedule P1
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Gireesh Babu, New Delh
March 20 , 2024
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The Union ministry of health and family welfare has notified amendment of Drugs Rules, 1945 to change the pack size norms related to the chest pain drugs glyceryl trinitrate and isosorbide dinitrate formulations, in order to help the patients to comply with the recommended dosage duration of the therapy.
The Ministry, which in September last year came up with a draft amendment, gave the decision its final nod through the final notification on March 18, 2024. The amendments are made in the Rule 105 of the Drugs Rules and the list under the Schedule P1, which stipulates pack sizes for certain drug formulations under the Drugs Rules. The notification has come into force on the date of final publication in the Official Gazette.
Through the amendment, these two formulations are omitted from the provisions for pack sizes of drugs under Schedule P1 of the Drugs Rules. It also amends the Rule 105 of the Drugs Rules, changing the package size requirements of drugs which are not specified under the Schedule P1 to the effect that in pack sizes of more than 10 capsules or tablets, the number of capsules could be in multiples of five and seven.
Prior to the amendment, as per the Rule 105, unless specified otherwise in Schedule P1, the pack sizes for tablets/capsules where the number of tablets/capsules is above 10, shall contain multiples of five. The amendment changes this requirement to “multiples of five or seven” tablets. Where the number of tablets (coated or uncoated), capsules (hard or soft gelatin) is less than 10, such packing shall be made by the integral number, according to the Rules.
In order to bring the formulations under this sub-rule, the amendment omitted the listing of these formulations from the Schedule P1. The Schedule P1 prior to this amendment stipulated the pack size of glyceryl trinitrate spansules (long acting) and isosorbide dinitrate spansules (long acting) as 25 per pack.
The Drugs Technical Advisory Board (DTAB) which earlier while considering the proposal for the amendment, observed that the pack size of 25 mandated for glyceryl trinitrate has to be deleted since it may result in dose non-compliance by the patients. The proposal was to revisit the pack size from 25 to 30 for all the nitroglycerin timed release solid oral dosage forms (tablets and capsules) to avoid possible non-compliance to this life saving drug.
All the strengths of nitroglycerin solid oral dosage forms are available in an even number of tablets/capsules pack and generally in packs of 30's or 60's to cover dosage of 15 or 30 days respectively considering the b.i.d dose.
The Schedule P1 [Rule 109] requirement is very specific to the "Glyceryl trinitrate spansules (long acting)" hence not applied for other dosage forms (tablets) and sold in India in even number of unit packs and mostly 30's pack to cover 15 days dose, it observed.
Within a pack of 25' one capsule is always left in the pack and there is risk of missing dose on 13th day by patient and high probability of dose non-compliance as there is only one capsule left in the bottle.
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