The Drugs and Cosmetics (Sixth Amendment) Rules, 2016 notified

NOTIFICATION
New Delhi, the 21st September, 2016

G.S.R. 897(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics 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 Government of India in the Ministry of Health and Family Welfare (Department of Health), number G.S.R. 705(E), dated the 19th July, 2016, published in the Gazette of India, Extraordinary, Part II, Section 3, sub-section (i), dated the 19th July, 2016, inviting objections and suggestions from all 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;

And whereas copies of the Gazette were made available to the public on 19.07.2016;
And, whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government;
Now, therefore, in exercise of the powers conferred under 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, 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 (Sixth Amendment) Rules, 2016.
(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Drugs and Cosmetics Rules, 1945,
(a) in Schedule D(I), in item 2, for “sub-item 2.3”, the following shall be substituted, namely:—

“2.3 A copy of Good Manufacturing Practice (GMP) certificate as per WHO – GMP guidelines or Certificate of Pharmaceutical Products (CPP) or written confirmation for active substances exported to European Union which is equivalent to GMP certificate issued as per WHO – GMP guidelines, by the National Regulatory Authority of the country of origin or a copy of the certificate equivalent to GMP certificate as per WHO GMP guidelines issued by National Regulator of United States of America or Japan or Australia or Canada or the European Union for the purpose of marketing of the drugs in their country, in relation to bulk drugs or formulations or special product meant for import into India.”

(b) in Schedule D(II), in item 1, for “sub-item 1.4”, the following shall be substituted, namely:-
“1.4 GMP certificate as per WHO-GMP format, or Certificate of Pharmaceutical Products (CPP), or written confirmation for active substances exported to the European Union which is equivalent to GMP certificate issued as per WHO – GMP guidelines, by the National Regulatory Authority of the country of origin or a duly notarised copy of the certificate equivalent to GMP certificate as per WHO-GMP guidelines issued by United States of America or Japan or Australia or Canada or the European Union for the purpose of marketing of the drug in their country.”

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. 789(E), dated 12.08.2016.

MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)

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