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Prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations.


MINISTRY OF HEALTH AND FAMILY WELEFARE

(Department of Health and Family Welfare)

NOTIFICATION

New Delhi, the 29th September, 2014

G.S.R. 701(E).—The following draft rules which the Central Government proposes to make, in exercise of the powers conferred by clause (i) of sub-section (2) of section 33 read with section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), on the recommendation of the Drugs Technical Advisory Board, is hereby published for the information of all persons likely to be affected thereby; and notice is hereby given that the said draft rules shall 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 this notification is made available to the public;

The objections and suggestions, if any, received from any person with respect to the said draft notification within the period so specified shall be taken into consideration by the Central Government;

The objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Room No. 523-A, Ministry of Health and Family Welfare, Government of India, Nirman Bhawan, New Delhi – 110011.

Draft Rules

1. Short title and commencement.—(1) These rules may be called the Prohibition of Use of Polyethylene Terephthalate or Plastic containers for primary packaging of drug formulations for using in certain cases Rules, 2014.

(2) They shall come into force after a period of one hundred and eighty days from the date of its final publication in the Official Gazette.

2. Prohibition of use of Polyethylene Terephthalate in liquid oral formulations for primary packaging of drug formulations.—No manufacturer shall use the Polyethylene Terephthalate or Plastic containers in liquid oral formulations for primary packaging of drug formulations for paediatric use, geriatric use and for use in case of pregnant women and women of reproductive age group.

3. Penalty for contravention.—Any manufacturer who contravenes the provisions contained in rule 2 shall be liable to penalty under the provisions of the Drugs and Cosmetics Act, 1940.

F. No. X.11014/10/2013-DFQC

K. L. SHARMA, Jt. Secy.

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and Published by the Controller of Publications, Delhi-110054