Last Updated on January 6, 2024 by The Health Master
Pack Size provisions for Tablets and Capsules
The Drugs Technical Advisory Board (DTAB) recently proposed an amendment to the provisions regarding pack sizes of tablets or capsules with quantities exceeding 10.
This recommendation suggests that pack sizes should be multiples of five or seven to align with the recommended duration of therapy.
The proposal specifically targets glyceryl trinitrate spansules, a cardiovascular drug, and aims to eliminate the mandatory pack size of 25, as it may lead to non-compliance in patient dosing.
Amendment Proposal for Pack Size Provision:
During a recent meeting, the DTAB extensively discussed amending Schedule P1 of the Drugs Rules, 1945, focusing on the pack size requirements for glyceryl trinitrate spansules.
The board unanimously agreed to remove the existing pack size mandate of 25 for glyceryl trinitrate spansules (long acting) due to concerns that this particular pack size might contribute to patient non-compliance.
Current Pack Size Regulations:
According to Rule 105, unless otherwise specified in Schedule P1, pack sizes for tablets or capsules containing more than 10 units should be in multiples of five.
For pack sizes of tablets (coated or uncoated) or capsules (hard or soft gelatin) containing fewer than 10 units, integral numbers should be used.
Recommended Amendment:
After careful examination of the existing provision, the DTAB proposed an amendment suggesting that pack sizes for tablets or capsules containing more than 10 units should be multiples of 5 or 7.
This revision takes into consideration the recommended duration of therapy to ensure patients receive an appropriate quantity for their treatment.
Representation Received:
The DTAB was made aware of a representation regarding the need to revisit and modify Rule 109 of Schedule P1, which currently requires a pack size of 25 for nitroglycerin timed-release solid oral dosage forms (tablets and capsules).
The representation emphasized the importance of changing the pack size to 30 for all nitroglycerin solid oral dosage forms to prevent potential non-compliance with this life-saving medication.
Availability of Nitroglycerin Dosage Forms:
The board was informed that all strengths of nitroglycerin solid oral dosage forms are available in packs with an even number of tablets or capsules, typically in sizes of 30 or 60.
These pack sizes correspond to a 15-day or 30-day supply, respectively, considering the recommended twice-daily dosage (b.i.d).
Specificity of the Requirement:
The requirement stated in Rule 109 of Schedule P1 is applicable only to “Glyceryl trinitrate spansules (long acting)” and does not extend to other tablet dosage forms sold in India.
Such tablets are typically packaged in even-numbered unit packs, predominantly in packs of 30 to cover a 15-day dosage.
Reasoning Behind the Proposal:
With the current pack size of 25 for glyceryl trinitrate spansules, one capsule always remains in the pack, posing a risk of missed doses on the 13th day and increasing the likelihood of non-compliance.
The DTAB thoroughly deliberated the matter and unanimously supported the proposal to remove the provisions from Schedule P1 of the Drugs Rules, 1945, specifically related to glyceryl trinitrate spansules.
Conclusion:
The Drugs Technical Advisory Board (DTAB) recommended an important amendment to the provisions governing the pack sizes of tablets and capsules.
This amendment seeks to ensure that pack sizes for tablets or capsules containing more than 10 units are multiples of five or seven, aligning with the recommended duration of therapy.
The proposal to delete the pack size requirement of 25 for glyceryl trinitrate spansules reflects the board’s commitment to patient safety and compliance.
By revisiting and modifying these regulations, the DTAB aims to enhance the effectiveness and adherence to medication regimens, particularly in the case of life-saving drugs like nitroglycerin.
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