Monday, October 5, 2015

Circular issued by Pharmexcil on 30/09/2015 to comply


Ref: PXL/H.O./CIR-087/2015-16                                         Date: 30.09.2015
Hyderabad


To
MEMBER (COA) PHARMEXCIL,

Dear Sir/Madam,


Subject: Bar coding Public Notice by DGFT dt: 22nd May 2015-Data uploading on Central Server / compliance -regarding

As our members are aware all exporters are required to comply stipulations made in the Public Notice dt: 22nd May 2015 by DGFT effective from 1st October 2015. Pharmexcil has been updating our members on this important issue regularly and arranged interaction / awareness programmes at Delhi (Ministry), Mumbai and Hyderabad etc., during the past 3/4 months. Pharmexcil has also forwarded the representations received from industry on various aspects of implementation of the notification to the Government.

In view of impending commencement of data uploading on central server from 1stOct, 2015, Council would like to send present status report immediately on preparedness of our members for the implementation of Public Notice dt: 22nd May 2015.

We would therefore request all our members to please inform the following:

1.    Present status of installation of software / hardware for data transfer to  central server (DAVA).
2.    Reasons for delays
3.    Suggestions

Our council would compile such data and forward the same to Government for consideration.

With regards,


Dr.P.V.Appaji
Director General

Wednesday, June 17, 2015

DRAFT NOTIFICATION FOR IMPLEMENTATION OF BAR CODE ON DOMESTIC MEDICINES

NOTIFICATION Dated 3rd June, 2015  

Whereas, the Central Government is of opinion that it is necessary to authenticate the genuineness of drugs and for this purpose, it has been proposed to amend the Drugs and Cosmetics Rules, 1945;
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.

 DRAFT RULES  

1.  (1) These rules may be called the Drugs and Cosmetics (Fifth Amendment) Rules, 2015.

 (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.

Thursday, May 28, 2015

Public Notice No. 13 /2015-2020 New Delhi, Dated the 22 May, 2015 Implementation of the Track and Trace system for export of drug formulations.

To be published in the Gazette of India Extraordinary Part-I, Section-I 
Government of India 
Ministry of Commerce and Industry 
Department of Commerce 
Directorate General of Foreign Trade 
Public Notice No. 13 /2015-2020 
New Delhi, Dated the 22 May, 2015 

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

 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 2.89 A of Handbook of Procedure, 2015-20, as notified vide Public Notice No. 4/2015-20 dated 01.04.2015, as under, for laying down the procedure for implementation of the Track and Trace system for export consignments of drug formulations: 

2. “2.89 A Procedure for Implementation of the Track and Trace system for export of drug formulations
 (i) 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 bar code labelling 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, 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) 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. However, maintenance of parent-child relationship between primary and secondary packaging is optional till further notification.

 (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.

 (v) 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) The exports of the drugs having manufacturing date prior to 01.10.2015 will be exempted from requirement of data uploading on central portal.

 (vii) With effect from 01.10.2015, all drugs with manufacturing date on or after 01.10.2015 can be exported only if both the 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. 

(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) Separate guidelines shall be issued for grant of exemption (s), data requirement, maintenance and upload on central portal.”

 3. Effect of this Public Notice: In supersession of the earlier Public Notice No. 4/2015-20 dated 1st April, 2015, the procedure for implementation of the Track and Trace system for export of drug formulations has been modified. 

(Pravir Kumar) 
Director General of Foreign Trade
 E-mail:dgft@nic.in
 (Issued from F.No. 01/91/180/648/AM 09/Export Cell) 

Tuesday, May 19, 2015

Setting up of Expert Group on Technology for Implementation of the Trace and Track system for Export of Drug Formulations-regd.

 Govt. vide F.No 15/71/2010-EP(Engg) dt. 15/5/2015 set up the Expert Group with the following members
From Govt. Side
1. Shri Sudhanshu Pandey, Joint Secretary, DoC     as Chairman
2. Shri Sudhansh Pant, Joint Secretary, DoP
3. Shri K.L.Sharma, Joint Secretary, MoH&FW
4. Dr. G.N.Singh, DCGI, MoH&FW
5. Shri S.Swaminathan, GM, GS1
6. Shri A.K.Sinha, DDG, NIC

Dr. P.V.Appaji, DG, Pharmaexcil as Member Secretary

President or his nominees of Indian Pharma Alliance, IDMA, ABLE, IADMA, BDMA

Prof N.C.Saha, Director & PEO, Indian Institute of Packaging

Consumer Organization representative

Terms of Reference: 1. Identify issues relating to the implementation of Trace and Track with authentication system and suggest possible solutions
2. Review of available technologies , Hardware, Software , Cost effectiveness
3. Suggest Business Process / Re-engineering required at Manufacturing level
4. Evaluating the costing at SME sector
5. Assessing the capability of the Vendors / service providers

Report to be submitted within 4 months

Tuesday, April 7, 2015

Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments.

Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
Public Notice No. 4 /2015-2020 New Delhi, Dated the 1 April, 2015
Subject: Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments.
In exercise of the powers conferred under Paragraph 1.03 of the Foreign Trade Policy, 2015-2020, as amended from time to time, the Director General of Foreign Trade hereby inserts Para 2.89 A in Handbook of Procedure, 2015-2020, as under, for laying down the procedure for implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments:

2. “2.89 A

Procedure for Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments
(i) The manufacturer of drug for 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 bar code labelling at primary level is exempted till further notification, however the above mentioned details are required to be printed in human readable form.
(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.
(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 [Serial Shipping Container Code (SSCC)] of the Tertiary pack.
(ii) The manufacturer shall maintain the data in the parent-child relationship for all three level of packaging i.e. Primary, Secondary and Tertiary and their movement in its supply chain.
(iii) The data mentioned in (ii) above, shall be uploaded on the central portal of the Government of India by the manufacturer or its designated agency before release of
the drugs 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.


The above rules will not be applicable to those drug formulation manufactured for export purposes, where the government of the importing country has mandated a specific requirement and the exporter intends to avail the option of printing the barcodes in their format with the permission of licensing authority appointed under rule 21. 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.
(v) The exports of the drugs having manufacturing date prior to 01.04.2015 will be exempted for requirement of barcode labelling and data uploading on central portal.
(vi) The drugs with manufacturing date on or after 01.04.2015 will compulsorily carry barcode on tertiary and secondary packages as per the Notification No. 68 dated 06.08.2014. However the requirement of data uploading on central portal will be exempted till 30.06.2015.
(vii) With effect from 01.07.2015, all drugs with manufacturing date on or after 01.04.2015 can be exported only if both the 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, primary packaging means the package which is in direct physical contact with the drug, secondary packaging means the carton containing multiple primary packs including a mono carton and tertiary packaging means a shipper containing multiple secondary packs.
(b) Separate guidelines shall be issued for data requirement, maintenance and upload on central portal.”
3. Effect of this Public Notice:
The procedure for implementation of the Track and Trace system for export of pharmaceutical and drug consignments has been notified.
(Pravir Kumar)
Director General of Foreign Trade
E-mail:dgft@nic.in
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)


Thursday, February 19, 2015

Steps to be taken to comply with DGFT's Track & Trace Requirements

The below communication which is also attached as doc could be forwarded to all your members to enable them comply with the Track & Trace portal requirements.

For any clarifications you may direct your members to our Implementation team at implementation@gs1india.org


With regards,


S.Swaminathan
General Manager
GS1 India


November 20, 2014
Dear Subscriber,
Sub: Steps to be taken to Comply with DGFT’s Track & Trace Requirements
As you may be aware, The Directorate General of Foreign Trade (DGFT) has notified that all drugs and pharmaceutical products that are exported from India need to implement a track and trace system using barcodes as per GS1 global standards.
As part of this track and trace system, a National Track & Trace Portal is being set up for the purpose of compliance with DGFT’s requirements for exported drugs and pharmaceutical products across various packaging levels.
The following product packaging level indicator digits need to be used by you in the GTIN’s (Global Trade Identification Numbers) for your products(The indicator digit refers to the first digit of a GTIN-14).
Product Packaging Indicator Number
Packaging Level
Indicator Number 5
Will denote the Tertiary packaging level [i.e. shipper/carton]
Indicator Number 1
Will denote the Secondary packaging level.  In the event of multiple secondary packaging levels, only the first level of secondary packaging requires to incorporate the packaging indicator number.
Indicator Number 0
Will denote the Primary packaging level [strip/vial/bottle, single therapy kits etc.]

To help companies prepare and be compliant with these product marking and coding requirements, GS1 India shall be providing technical guidance through workshops at select locations (as below) and internet based webinar training sessions.
·         The workshops will be held at GS1 India offices in New Delhi, Mumbai and Bangalore. You can view the schedule here:http://gs1india.org/service/education-training/workshop
·         The schedule for the internet based webinar training sessions can be viewed here: http://gs1india.org/service/education-training/webinar
Please register for any one of these upcoming training sessions immediately by emailing us at workshop@gs1india.org. We have limited seating capacity so please reserve your spot today.
At the training workshops, guidance shall also be provided on how to ensure scannability of barcodes in a variety of scanning environments using barcode verification service provided by GS1 India.
For any additional questions or clarifications on these product marking and coding requirements please contact us atimplementation@gs1india.org.

Thanking you,

GS1 India Implementation Team