Drugs and Cosmetics (5th Amendment) Rules, 2017, notified

G.S.R. 250(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published as required by Section 12 and 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. 44(E), dated the 17th January, 2017, published in the Gazette of India, Extraordinary, Part II, Section 3, sub-section (i), dated the 17th January, 2017, inviting objections and suggestions from persons likely to be affected thereby before the expiry of a period of thirty 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 17th January, 2017;

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 and 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 (5th Amendment) Rules, 2017.

    (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 Rule 3A, in sub-rule (8), in clause (b), after item (5) and the entries relating thereto, the following shall be inserted, namely:-

“(6) Enzyme and Hormones such as-

 (a) Streptokinase (Natural and Recombinant);

 (b) Human Chorionic Gonadotropin (hCG);

 (c) Human Menopausal Gonadotropin (hMG).

 (7) Bacterial vaccine such as-

 (a) Bacillus Calmette-Guerin (BCG) vaccine.

(8) Viral vaccines such as-

 (a) Live attenuated Measles vaccine;

 (b) Live attenuated Rubella vaccine;

 (c) Cell culture Rabies vaccine”

 [F. No. A.11018/2/2016-DFQC]

Note : The principal rules were published in the Official Gazette vide notification number F.28-10/45-H (1), dated the 21st December, 1945 and last amended vide notification number G.S.R. 103 (E) dated the 02nd February, 2017.

Ministry of Health and Family Welfare

(Department of Health and Family Welfare)

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