Notification, 2018

Text

Reproduced from the document India Code holds for this instrument. The Gazette prints Hindi and English side by side and this is the English; the Department's own PDF remains the authority.

EXTRAORDINARY

PUBLISHED BY AUTHORITY

No. 253] NEW DELHI, WEDNESDAY, APRIL 18, 2018/CHAITRA 28, 1940 �वा��य और प

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health and Family Welfare)

NOTIFICATION

New Delhi, the 18th April, 2018

G.S.R. 381(E).—The following draft of certain rules, 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), in consultation with the Drugs Technical Advisory Board is hereby published for 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 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.

Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.

DRAFT RULES

1. (1) These rules may be called the Drugs and Cosmetics ( Amendment) Rules, 2018.

(2) These rules shall come into effect after one hundred eighty days of the publication of the final rules in the Gazette of India.

2. In the Drugs and Cosmetics Rules, 1945, in rule 96, in sub-rule (1), after clause (xii) the following clause shall be inserted, namely:- "(xiii) (A). The manufacturers of drug formulations of oxytocin shall print the details specified below to facilitate tracking and tracing of their products, namely:- a. at primary level packaging of two dimensional barcode encoding unique and universal global product identification code in the 14 digits Global Trade Item Number format along with batch number, expiry date and a unique serial number of the primary pack; b. at secondary level packaging of one or two dimensional barcode encoding unique and universal global product identification code in the 14 digits Global Trade Item Number format along with batch number, expiry date and a unique serial number of the secondary pack; c. at tertiary level packaging of one dimensional barcode encoding unique and universal global product identification code in the 14 digits Global Trade Item Number format along with batch number, expiry date and a unique serial number of the Tertiary pack. (B) The manufacturer of drug formulation shall maintain the data in the parent — child relationship for all three level of packaging and their movement in its supply chain. (C) The data referred to in sub-rule (2) shall be uploaded on the central portal of the Central Government by the manufacturer or its designated agency before release of the drugs for sale or distribution.

(D) The responsibility of the correctness, completeness and ensuring timely upload of data on the Central portal shall be that of the manufacturer.

Explanation.— For the purposes of these rules -

(i) (a) primary packaging level means the package which is in physical contact with the drug;

(b) secondary packaging level means the carton containing multiple primary packs including a mono carton and

(c) tertiary packaging level means a shipper containing multiple secondary packs as per guidelines issued for data requirement by the Central Government.

(ii) Parent-child relationship between tertiary, secondary and primary packaging levels means

(a) relationship between tertiary and secondary packs is the tertiary pack as the parent and secondary pack as the child; and

(b) relationship between secondary and primary packs is the secondary pack as the parent and primary pack as the child.".

SUDHIR KUMAR, Jt. Secy.

Foot note : The principal rules were published in the Official Gazette vide notification No. F.28-10/45-H

(1) dated 21st December, 1945 and last amended vide notification number G.S.R. (E) dated .

and Published by the Controller of Publications, Delhi-110054.

RAKESH SUKUL

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