The Ministry of Health and Family Welfare has notified the Drugs (Second Amendment) Rules, 2024. These rules, have come into force from March 18, 2024. They seek to bring about alterations to the existing framework under the Drug Rules, 1945.
These amendment rules aim to accommodate greater flexibility in packaging. After the phrase “multiples of 5,” the provision now includes the option for packaging in multiples of 7 as well.
Therefore by the present amendment, where the number of tablets (coated or uncoated)/Capsules (hard or soft gelatin) is more than 10, the pack size of Tablets/Capsules shall contain multiples of 5 or 7. This adjustment is expected to provide manufacturers with more versatile options in packaging sizes, potentially enhancing efficiency in drug distribution and administration.
Furthermore, the amendment impacts Schedule P1 of the principal rules, which pertains to the “PACK SIZES OF DRUGS.” Notably, the drugs “Glyceryl Trinitrate” and “Isosorbide Dinitrate,” along with their corresponding entries, have been omitted from the schedule. This alteration reflects a strategic revision in the listing of drugs and their permissible packaging sizes, aligning with evolving standards and requirements in the pharmaceutical sector.
These amendments underscore the ongoing efforts to ensure that drug regulations remain relevant and responsive to the dynamic landscape of healthcare and pharmaceuticals. The amendments reflect a proactive approach towards enhancing regulatory frameworks, ultimately contributing to the delivery of quality healthcare services and the promotion of public health and safety.
