{"id":72142,"date":"2016-09-22T14:12:54","date_gmt":"2016-09-22T08:42:54","guid":{"rendered":"http:\/\/www.scconline.com\/blog\/?p=72142"},"modified":"2018-04-27T11:35:32","modified_gmt":"2018-04-27T06:05:32","slug":"the-drugs-and-cosmetics-sixth-amendment-rules-2016-notified","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2016\/09\/22\/the-drugs-and-cosmetics-sixth-amendment-rules-2016-notified\/","title":{"rendered":"The Drugs and Cosmetics (Sixth Amendment) Rules, 2016 notified"},"content":{"rendered":"<p style=\"text-align: center;\"><strong>NOTIFICATION<\/strong><br \/>\nNew Delhi, the 21st September, 2016<\/p>\n<p style=\"text-align: justify;\"><strong>G.S.R. 897(E).\u2014<\/strong>Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,\u00a01945, was published, as required by Section 12 read with Section 33 of the Drugs and Cosmetics Act, 1940\u00a0(23 of 1940), vide notification of the Government of India in the Ministry of Health and Family Welfare\u00a0(Department of Health), number G.S.R. 705(E), dated the 19th July, 2016, published in the Gazette of India,\u00a0Extraordinary, Part II, Section 3, sub-section (i), dated the 19th July, 2016, inviting objections and\u00a0suggestions from all persons likely to be affected thereby before the expiry of a period of forty five days\u00a0from the date on which the copies of the Official Gazette containing the said notification were made\u00a0available to the public;<\/p>\n<p style=\"text-align: justify;\">And whereas copies of the Gazette were made available to the public on 19.07.2016;<br \/>\nAnd, whereas, objections and suggestions received from the public on the said rules have been\u00a0considered by the Central Government;<br \/>\nNow, therefore, in exercise of the powers conferred under section 12 read with section 33 of the\u00a0Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs\u00a0Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics\u00a0Rules, 1945, namely:-<\/p>\n<p style=\"text-align: justify;\">1. (1)These rules may be called the Drugs and Cosmetics (Sixth Amendment) Rules, 2016.<br \/>\n(2) They shall come into force on the date of their publication in the Official Gazette.<\/p>\n<p style=\"text-align: justify;\">2. In the Drugs and Cosmetics Rules, 1945,<br \/>\n(a) in Schedule D(I), in item 2, for \u201csub-item 2.3\u201d, the following shall be substituted, namely:\u2014<\/p>\n<p style=\"text-align: justify;\">\u201c2.3 A copy of Good Manufacturing Practice (GMP) certificate as per WHO \u2013 GMP guidelines or\u00a0Certificate of Pharmaceutical Products (CPP) or written confirmation for active substances exported\u00a0to European Union which is equivalent to GMP certificate issued as per WHO \u2013 GMP guidelines, by\u00a0the National Regulatory Authority of the country of origin or a copy of the certificate equivalent to\u00a0GMP certificate as per WHO GMP guidelines issued by National Regulator of United States of\u00a0America or Japan or Australia or Canada or the European Union for the purpose of marketing of the\u00a0drugs in their country, in relation to bulk drugs or formulations or special product meant for import\u00a0into India.\u201d<\/p>\n<p style=\"text-align: justify;\">(b) in Schedule D(II), in item 1, for \u201csub-item 1.4\u201d, the following shall be substituted, namely:-<br \/>\n\u201c1.4 GMP certificate as per WHO-GMP format, or Certificate of Pharmaceutical Products (CPP), or\u00a0written confirmation for active substances exported to the European Union which is equivalent to\u00a0GMP certificate issued as per WHO \u2013 GMP guidelines, by the National Regulatory Authority of the\u00a0country of origin or a duly notarised copy of the certificate equivalent to GMP certificate as per\u00a0WHO-GMP guidelines issued by United States of America or Japan or Australia or Canada or the\u00a0European Union for the purpose of marketing of the drug in their country.\u201d<\/p>\n<p><strong>Note.-<\/strong> The principal rules were published in the Gazette of India vide notification No. F. 28-10\/45-H (1),\u00a0dated 21st December, 1945 and last amended vide notification number G.S.R. 789(E), dated\u00a012.08.2016.<\/p>\n<p style=\"text-align: right;\">MINISTRY OF HEALTH AND FAMILY WELFARE<br \/>\n(Department of Health and Family Welfare)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>NOTIFICATION New Delhi, the 21st September, 2016 G.S.R. 897(E).\u2014Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,\u00a01945, <\/p>\n","protected":false},"author":91,"featured_media":47491,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14,4],"tags":[],"class_list":["post-72142","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-foreign","category-legislationupdates"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>The Drugs and Cosmetics (Sixth Amendment) Rules, 2016 notified | SCC Times<\/title>\n<meta name=\"robots\" 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