Glyceryl Trinitrate, Isosorbide Dinitrate Removed from Schedule P1: MoHFW

New Delhi: The Ministry of Health and Family Welfare has amended the Drugs Rules, 1945 by removing Glyceryl Trinitrate and Isosorbide Dinitrate from Schedule P1 which contains regulations regarding the retail package size of various drugs.

The amended rules furthermore stated that, for drugs not covered by Schedule P-1, the pack sizes of tablets and capsules should be as follows: if the number of tablets (coated or uncoated) or capsules (hard or soft gelatine) is less than 10, the packing should be made according to the integral number; if the number is more than 10, the pack sizes of tablets and capsules should contain multiples of five or seven.

The Drugs and Cosmetics Rules, of 1945 are the rules which the government of India established through the Drugs and Cosmetics Act, 1940. These rules classify drugs under given schedules and present guidelines for the storage, sale, display, and prescription of each schedule.

Schedule P contains regulations regarding the life period and storage of various drugs and Schedule P-I contains regulations regarding the retail package size of various drugs.

A draft of certain rules further to amend the Drugs Rules, 1945, was published, as required by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Ministry of Health and Family Welfare, Department of Health and Family Welfare, number G.S.R. 687 (E), dated the 25th September 2023, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from the persons likely to be affected thereby before the expiry of a period of forty-five days from the date on which the copies of the Official Gazette containing the said notification were made available to the public.

Copies of the said Gazette notification were made available to the public on 26th September 2023. In line with this, objections and suggestions received from the public on the said rules have been considered by the Central Government.

Therefore, in the exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, has made the following rules further to amend the Drugs Rules, 1945, namely;-

"1. Short title and commencement

(1) These rules may be called the Drugs (Second Amendment) Rules, 2024.

(2) They shall come into force on the date of their final publication in the Official Gazette.

2. In the Drugs Rules, 1945, (hereinafter referred to as the principal rules), in rule 105, in sub-rule (2), in clause (i), after the words, and figure, “multiples of 5”, the word and figure “or 7” shall be inserted.

3. In the principal rules, in Schedule P1, under the heading “PACK SIZES OF DRUGS”, the drugs “Glyceryl Trinitrate” and “Isosorbide Dinitrate” mentioned in column 1 and entries relating thereto in columns 2 and 3 shall be omitted."

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