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(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

1. 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.”.

1. Printing of details on the label

The details provided in the adjacent column must be printed for each level of packaging.

i.              Primary level packaging means the package which is in physical contact with the drug.

ii.             Secondary level packaging means the carton containing multiple primary packs including a mono carton.

iii.            Tertiary level packaging means a shipper containing multiple secondary packs as per guidelines issued for data.

1. Maintenance of data

Manufacturers of drug formulations of oxytocin are required to maintain the data in the parent-child relationship for all three levels of packaging mentioned above, on the basis of the following relationship criteria:

1. Relationship between tertiary and secondary packs- Tertiary pack (parent) and Secondary pack (child).
2. Relationship between secondary and primary packs- Secondary pack (parent) and Primary pack (child).

1. Uploading of data

Manufacturers have been mandated to upload the data in point 2 above on the central portal of the Central Government,  before selling or distributing drugs.

1. Responsibility to ensure correctness of data

It is to be noted that the manufacturer is responsible to confirm the correctness, completeness and ensuring timely upload of data.