Ministry of Health and Family Welfare proposes to amend the labelling requirements for drug formulations of oxytocin

Ministry of Health and Family Welfare proposes to amend the labelling requirements for drug formulations of oxytocin

April 26, 2018 Industry Specific 0

In a recent notification dated April 18, 2018, the Ministry of Health and Family Welfare (“Ministry”) has invited suggestions and objections to the draft Drugs and Cosmetics (Amendment) Rules, 2018 (“Draft Amendment Rules”), that proposes to amend the Drugs and Cosmetics Rules, 1945 (“Principal Rules”).

Key Highlights of the Draft Amendment:

 

Principal Rules Draft Amendment Rules Impact
     
Rule 96: Manner of Labelling

 

Rule 96: Manner of Labelling

 

(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.”.

 

The Draft Amendment Rules have proposed to introduce a clause with regard to packaging of drug formulations of oxytocin. This clause is addressed to manufacturers of drug formulations of oxytocin. The following obligations have been imposed on manufacturers to facilitate tracking and tracing of their products.

 

  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.

 

 

Comments/ suggestions have been invited to the following address, within a period of forty-five days from April 18,2018.

Under Secretary (Drugs)

Ministry of Health and Family Welfare,

Government of India,

Room No. 414 A, D Wing,

Nirman Bhavan,

New Delhi – 110011

Email: drugsdiv-mohfw@gov.in

Source: Ministry of Health and Family Welfare

About the author

Lexplosion:

0 Comments

Would you like to share your thoughts?

Your email address will not be published. Required fields are marked *

Leave a Reply