The Importance of Amending Drugs Rules: Pack size of drugs

The amendment primarily targets Rule 105 of the Drugs Rules and Schedule P1, which delineates pack sizes for various drug formulations.

The Health Master

March 20, 2024

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Last Updated on April 3, 2024 by The Health Master

Drugs Rules

In a recent move aimed at enhancing patient care and adherence to prescribed medication regimens, the Union ministry of health and family welfare has brought about significant changes to the Drugs Rules of 1945.

This amendment specifically targets the pack size norms concerning vital chest pain drugs, glyceryl trinitrate, and isosorbide dinitrate formulations.

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Background Information

Origins of the Amendment: The need for this amendment stems from the necessity to align drug regulations with patient needs and recommended dosage duration.
Previous Regulations: Prior to this amendment, the Rules mandated specific pack sizes for these medications, potentially hindering patient compliance.

Download notification No. GSR No. 216(E) dt 18-03-2024 Pack size of drugs in multiple of 7

Details of the Amendment

Notification and Approval: The Ministry officially notified the amendment on March 18, 2024, following a draft proposal introduced in September the previous year.
Scope of Changes: The amendment primarily targets Rule 105 of the Drugs Rules and Schedule P1, which delineates pack sizes for various drug formulations.
Immediate Implementation: The notification came into effect immediately upon publication in the Official Gazette.

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Changes Implemented

Omission of Formulations: The amendment removes glyceryl trinitrate and isosorbide dinitrate formulations from the provisions governing pack sizes under Schedule P1.
Revised Package Size Requirements: Rule 105 now stipulates that pack sizes containing more than 10 capsules or tablets must be in multiples of five and seven, offering greater flexibility in dosing.

Download Schedule P

Rationale Behind the Amendment

Patient Compliance Concerns: The previous pack size requirements risked non-compliance due to inadequate dosage duration, particularly for life-saving medications like glyceryl trinitrate.
Medical Expertise: The Drugs Technical Advisory Board (DTAB) highlighted concerns regarding patient adherence and recommended adjustments to ensure sufficient dosage coverage.

Implications of the Amendment

Enhanced Patient Safety: By accommodating larger pack sizes and ensuring adequate dosage coverage, the amendment promotes safer medication practices.
Improved Treatment Outcomes: Ensuring patients have access to the prescribed dosage for the recommended duration can lead to better treatment outcomes and management of chest pain conditions.

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