48 GI/2016

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REGD. NO. D. L.-33004/99

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EXTRAORDINARY

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PART I—Section 1

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PUBLISHED BY AUTHORITY

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THE GAZETTE OF INDIA : EXTRAORDINARY

[PART I—SEC. 1]

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MINISTRY OF COMMERCE AND INDUSTRY

(Department of Commerce)

(DIRECTORATE GENERAL OF FOREIGN TRADE)

PUBLIC NOTICE

New Delhi, the 5th January, 2016

No. 52/2015-2020

Subject: Implementation of the Track and Trace system for export of Pharmaceuticals and drug

consignments.

F. No. 01/91/180/648/AM 09/Export Cell/909.—In exercise of the powers conferred under

Paragraph 2.04 of the Foreign Trade Policy, 2015-20, as amended from time to time, the Director General of

Foreign Trade hereby amends Para 2.89A of Handbook of Procedure, 2015-20, as notified vide Public

Notice No. 4/2015-20 dated 1.04.2015 (as amended), as under, for laying down the procedure for

implementation of the Track and Trace system for export consignments of drug formulations:

“2.89 A

Procedure for Implementation of the Track and Trace system for export of drug formulations

The manufacturer or the exporter of drug formulations will print the barcode as per GS1

Global Standard at different packaging levels to facilitate tracking and tracing of their

products. The details are as follows:

(a) Primary Level:

Incorporation of two dimensional (2D) barcode encoding unique and universal global

product identification code in the format of 14 digits Global Trade Item Number (GTIN)

along with batch number, expiry date and a unique serial number of the primary pack. The

THE GAZETTE OF INDIA : EXTRAORDINARY

[PART I—SEC. 1]

bar code labeling at primary level is exempted till further notification; however, the above

mentioned details are required to be printed in human readable form on optional basis till

further notification.

(b) Secondary level:

Incorporation of one or two dimensional (1D or 2D) barcode encoding unique and universal

global product identification code in the format of 14 digits Global Trade Item

Number(GTIN) along with batch number, expiry date and a unique serial number of the

secondary pack. However, incase of monocartons manufacturer or exporter shall affix bar

code on mono carton containing one primary pack on optional basis till further notification.

(c) Tertiary Level:

Incorporation of one dimensional (1D) barcode encoding unique and universal global

product identification code in the format of 14 digits Global Trade Item Number (GTIN)

along with batch number, expiry date and a unique serial number of the tertiary pack i.e.

Serial Shipping Container Code (SSCC).

(ii)

Parent –Child Relationship/ Effective dates for SSI and Non-SSI Manufacturers:

The manufacturer or exporter shall maintain the data in the parent-child relationship for

three levels of packaging i.e. Primary, Secondary and Tertiary packaging and their

movement in its supply chain.

a) All Manufacturers (SSI & Non- SSI Manufacturers):

As one time exemption all manufacturers are exempted from maintenance of Parent-Child

relationship in packaging and its uploading on central portal (http://dava.gov.in) till

31.03.2016. However, the requirements of printing of barcoding on the different levels or

packaging will be applicable as prescribed.

(b) Extended Date of Exemption to SSI Manufacturers:

All SSI drug manufacturers are exempted from requirement of maintaining Parent-Child

relationship in packaging levels for a further period up to 31.03.2017. However, they are

required to upload Tertiary level data on the central portal mandatorily as prescribed in

public notice no. 13/2015-2020 dated 22.05.2015.

iii.

The data mentioned in (ii) above shall be uploaded on the central portal of the Government

of India by the manufacturer or exporter or its designated agency before release of the drug

formulations for sale or distribution.

iv.

The responsibility of the correctness, completeness and ensuring timely upload of data on

the central portal shall be with the manufacturer or exporter.

The above rules (i) to (iv) will not be applicable to those drug formulations manufactured

for export purposes, where the government of the importing country has mandated or

formally notified its intention to mandate a specific requirement and the exporter intends to

avail the option of printing the barcodes in their format after duly obtaining the permission

of DCGI or its nominee. However, the tertiary level of packaging will have additional

printing of barcode as per (i)(c) above in addition to importing country’s requirement, if

any.

vi.

Export of drugs manufactured by non-SSI units and having manufacturing date prior to

31.03.2016 and export of the drugs manufactured by SSI units and having manufacturing

date prior to 31.03.2017 are exempted from requirement of data uploading on Central

Portal.

vii.

All drugs manufactured by non SSI units with manufacturing date on or after 01.04.2016

and all drug manufactured by SSI units with manufacturing date on or after 01.04.2017 can

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be exported only if both tertiary and secondary packaging carry barcoding as applicable and

the relevant data as prescribed by DGFT is uploaded on the Central Portal.

Explanation:

(a) For the purpose of this rule,

(i) Drug formulation means a formulation manufactured with a license from Drug Control

Authority under the provisions of Drugs & Cosmetics Act and Rules made there under and

registered as “Drug” with the FDA of importing country.

(ii) Primary packaging means the package which is in direct physical contact with the active

ingredient.

Secondary packaging means a carton containing one or more primary packs and

includes a mono carton containing one primary pack.

The tertiary packaging means a shipper containing one or more secondary packs.

(b) All relevant guidelines regarding grant of specific exemption (s) if any, procedure of data

requirement / maintenance / upload on central portal and clarifications issued under this

notification etc. will be available on the central portal i.e. http://dava.gov.in

satisfy the customs authorities that the export consignment satisfies the conditions of the

notification”.

Effect of this Public Notice:

In suppression of the earlier Public Notice no. 13/2015-2020 dated 22.05.2015, the dates for

implementation of Track and Trace system for export of drug formulations alongwith maintaining

the Parent-Child relationship in packaging have been extended to 01.04.2016 for non SSI

manufactured drugs and to 01.04.2017 for SSI manufactured drugs.

ANUP WADHAWAN, Director General of Foreign Trade

Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064

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