NOTIFICATION Dated 3rd June, 2015
And Whereas, the Central Government has consulted the Drugs Technical Advisory Board for carrying out the amendments in the said rules;
The following draft of certain 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), is hereby published as required under sections 12 and 33 of the said Act, 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 these draft rules are made available to the public;
Any person interested in making any objection or suggestion on the proposed draft rules may do so in writing for consideration of the Central Government within the period so specified to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Nirman Bhawan, New Delhi-110011.
(2) They shall come into force after the expiry of 180 days from the date 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 shall print the details specified below to n facilitate tracking and tracing of their product-
(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-clause (B) 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 timely uploading of data on the Central portal shall be that of the manufacturer:
Provided that the provision of this sub-rule shall not be applicable to such drug formulation which is manufactured for export purpose and where the Government of the importing country has mandated a specific requirement and the exporter intends to avail the option of printing the bar codes in the format specified by the importing country with the permission of licensing authority appointed under rule 21:
Provided further that the tertiary level of the packaging shall have an additional printing of barcode as per sub-clause (A) in addition to any other requirement by the importing country.
Explanation.- For the purposes of this clause,-
(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 is the child; and
(b) relationship between secondary and primary packs is the secondary pack as the parent and primary as the child.”.
Sd/- (K.L. Sharma) Jt. Secy.
G.S.R. 449(E) F.No.02/Misc./2010-DC/DFQC Issued by: Ministry of Health and Family Welfare (Department of Health and Family Welfare) New Delhi
Note: The principal rules were published in the Gazette of India vide notification No.F.28-10/45-H (1) dated the 21st December, 1945 and last amended vide notification number GSR 390(E), dated the 18th May, 2015.