Draft Drugs and Cosmetics (…Amendment) Rules, 2018

Ministry of Health and Family Welfare vide notification dated April 18, 2018 has issued draft Drugs and Cosmetics (…Amendment) Rules, 2018 further the Drugs and Cosmetics Act, 1940. Vide this amendment-

In rule 96, in sub-rule (1), new clause (xiii) shall be inserted which reads as-

(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.

Any Objection or suggestion on the said draft rules may be sent 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, within Forty-Five (45) days from the date on which the copies of this notification as published in the Official Gazette, are made available to the public

These rules shall come into effect after one hundred eighty (182) days of the publication of the final rules in the Gazette of India

[G.S.R. 381(E)]

URL: http://www.egazette.nic.in/WriteReadData/2018/184866.pdf