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 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare NOTIFICATION New Delhi, the 18th April, 2019   G.S.R. 317 (E) — Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, was published, as required under sub-section(1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R.187(E), dated the 6th March, 2019, published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of ten days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas, copies of the said Official Gazette were made available to the public on the 7th March, 2019; And whereas, no objections or suggestions were received from the public on the said rules for consideration by the Central Government; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely: 1.            (1) These rules may be called the Drugs and Cosmetics (Tenth Amendment) Rules, 2019. (2) They shall come into force on the date of their publication in the Official Gazette. 2.            In the Drugs and Cosmetics Rules, 1945, in SCHEDULE A, (a) in FORM 45, under the sub-heading “Conditions for grant of approval / permission”, (i) for paragraph (2), the following paragraph shall be substituted, namely: “(2) The proper name of the drug or fixed dose combination drug other than fixed dose combinations of vitamin and other fixed dose combinations containing three or more drugs, shall be printed or written in a conspicuous manner which shall be at least two font size larger than the brand name or the trade name, if any, and in other cases the brand name or the trade name, if any, shall be written below or after the proper name on the label of the innermost container of the drug or every other covering in which the container is packed.”; (ii) in paragraph (3), for the words “conspicuous red and vertical line on the left side running throughout the body of the label which shall not be less than 1 mm in width and”, the words “caution or warning, as applicable, depending on whether the drug is covered under Schedule G or Schedule H or Schedule H1 or Schedule X, as specified in rule 97, in legible black coloured font size in a completely red rectangular box” shall be substituted; (b) In FORM 46, under the sub-heading “Conditions for grant of approval / permission”,- (i) for paragraph (2), the following paragraph shall be substituted, namely: “(2) The proper name of the drug or fixed dose combination drug other than fixed dose combinations of vitamin and other fixed dose combinations containing three or more drugs, shall be printed or written in a conspicuous manner which shall be at least two font size larger than the brand name or the trade name, if any, and in other cases the brand name or the trade name, if any, shall be written below or after the proper name on the label of the innermost container of the drug or every other covering in which the container is packed.”; (ii) in paragraph (3), for the words “conspicuous red and vertical line on the left side running throughout the body of the label which shall not be less than 1 mm in width and”, the words “caution or warning, as applicable, depending on whether the drug is covered under Schedule G or Schedule H or Schedule H1 or Schedule X, as specified in rule 97, in legible black coloured font size in a completely red rectangular box” shall be substituted. [F. No. X.11014/37/2018-DR] Dr. MANDEEP K BHANDARI, Jt. Secy.   Note:    The principal rules were published in the Gazette of India vide notification No. F.28-10/45-H(1), dated 21st December 1945 and last amended vide notification number G.S.R. 231(E), dated the 20th March, 2019.