Ministry of Health and Family Welfare

28.12.2016

Civil

Drugs and Cosmetics (Amendment) Rules, 2016 – draft

MANU/HFAM/0451/2016

The following draft of rules further to amend the Drugs and Cosmetics Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, is hereby published as required by said sections for the information of all persons likely to be affected thereby, and notice is hereby given that said draft rules will be taken into consideration on or after the expiry of a period of forty-five days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public. Objections and suggestions which may be received from any person within the period specified above, will be considered by the Central Government.

Draft rules

1.       (1) These rules may be called the Drugs and Cosmetics (Amendment) Rules, 2016.

(2) They shall come into force on date of their final publication in the official Gazette.

2. In the Drugs and Cosmetics Rules, 1945, in rule 64, in sub-rule (2), in the second proviso, for clause (ii), the following clause shall be substituted, namely:-

"(ii) in the charge of a competent person who is a registered pharmacist:

Provided that the person already registered with the state Licensing Authority as competent person for the purposes of grant of license in Form 20B or Form 21 B or both prior to the coming into force of the Drugs and Cosmetics (Amendment) Rules, 2016, shall continue to be considered as a competent person for the said purposes."

Tags : Rules Draft Amendment

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