Notification, 2015

Text

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EXTRAORDINARY

PUBLISHED BY AUTHORITY

No. 489] NEW DELHI, FRIDAY, JULY 31, 2015/SHRAVANA 9, 1937

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health and Family Welfare)

NOTIFICATION

New Delhi, the 31st July, 2015

G.S.R. 611(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 and Family Welfare), number

G.S.R. 364(E), dated the 7 th June, 2013, published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), dated the 7 th June, 2013, 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 07 th June, 2013;

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 (Fifth Amendment) Rules, 2015.

(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 Y,—

(i) in paragraph 2 under the heading “CLINICAL TRIAL”, in sub-paragraph (4) relating to “Informed Consent”, after clause (iii), the following shall be inserted, namely:— “(iv) An audio - video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record; Provided that in case of clinical trial of anti-HIV and anti-Leprosy drugs, only audio recording of the informed consent process of individual subject including the procedure of providing information to the subject and his understanding on such consent shall be maintained by the investigator for record.”;

(ii) in APPENDIX V, under the heading “INFORMED CONSENT”, in sub-heading 1.1 relating to “Essential Elements”, for serial number 14 and the entries relating thereto, the following serial numbers and entries shall be substituted, namely:— “14. Statement that there is a possibility of failure of investigational product to provide intended therapeutic effect.

15. Statement that in the case of placebo controlled trial, the placebo administered to the subjects shall not have any therapeutic effect.

16. Any other pertinent information.”.

NIKUNJA BIHARI DHAL, Jt. Secy.

Note : The principal rules were published in the Official Gazette vide notification No. F.28-10/45- H (1) dated the 21 st December, 1945 and last amended vide notification number

G.S.R. 390(E) dated the 18 th May, 2015.

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Provisions this notification answers to

Read out of the instrument itself: an enabling provision is one it says it was made under, which is the power it rests on. The rest it names without resting on.

Other instruments under the same Act

All of the The Drugs and Cosmetics Act, 1940