self-certification - P.No. 56 dt. 1.4.2014

Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade

Public Notice No. 56 (RE-2013)/2009-2014

New Delhi, Dated the 1 April, 2014

Sub: Self-certification regarding compliance of bar-coding requirements on secondary and tertiary level packaging on export consignment of pharmaceuticals and drugs.

In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2009-14, Director General of Foreign Trade hereby prescribes the procedure for self-certification regarding compliance of bar-coding requirements on secondary and tertiary level packaging on export consignment of pharmaceuticals and drugs.

2. Bar-coding on tertiary level packaging has come into effect from 1^st October, 2011 as per Public Notice No. 59 of 30.06.2011.Similarly on secondary level packaging this has come into effect from 1^st January, 2013 as per Public Notice No. 10 of 11.07.2012. The requirement of bar-coding on primary level packaging will come into effect from 1^st July, 2014.

3. It has been decided that with effect from 01.04.2014, export of pharmaceuticals and drug consignment would be permitted through a self-certification process. In this process, the exporters would be required to furnish a written declaration to the custom authorities at the time of export [as per Annexure to this public notice] regarding compliance of the relevant provisions of bar-coding on secondary and tertiary level packaging on the consignment of pharmaceuticals and drugs being exported.

4. Effect of this Public Notice:

A self-certification process on compliance of bar-coding requirement on secondary and tertiary level packaging of pharmaceuticals and drugs has been introduced. This will be effective from 1^st April, 2014

(Madhusudan Prasad)
Director General of Foreign Trade
E-mail : dgft[at]nic[dot]in

(Issued from F.No. 01/91/180/648/AM09/Export Cell)

Annexure to Public Notice No. 56 (RE-2013)/2009-14 dated 1 April, 2014

(On letter head of Exporter containing details of Company phone numbers, e-mail & website etc)

Exporter’s Declaration to Customs Officer of the relevant port for Pharma Products relating to compliance of track and trace capability and product registration.

(The exporter’s declaration, the text of which is given below, must be made out in accordance with the footnotes. However, the footnotes do not have to be reproduced.)

DECLARATION

1A. I, the undersigned, declare that the goods listed for export vide our invoice no. --------------------dated----------------------and Shipping BillNo.--------------------------dated----------------------and No.----------- dated-----------satisfy/comply with the requirements of the Public Notices issued by the Directorate General of Foreign Trade (Department of Commerce) as listed below:

          i.    Public Notice No. 21 (RE-2011)/2009-2014 dated 10.01.2011

         ii.    Public Notice No. 59 (RE-2010)/2009-2014 dated 30.06.2011 (applicable for tertiary level packaging)

        iii.    Public Notice No. 60 (RE-2010)/2009-2014 dated 30.06.2011

        iv.    Public Notice No. 10 (RE-2012)/2009-2014 dated 11.07.2012 (applicable for secondary level packaging)

         v.    Public Notice No. 31 (RE-2013)/2009-2014 dated 17.10.2013

1B. I declare that the Government authority of importing country--------------------(name) has its own legislation/regime regarding track and trace capability and therefore GS1 Data Matrix for the packaging as required under para 3 of Public Notice No. 59 (RE-2010)/2009-2014 dated 30.06.2011, is not applicable in this consignment.

2A. I also declare that the goods in the consignment are being exported to ---------- (name of country) and that the products being exported hold necessary registration/approval issued by the concerned government authorities of importing country.

2B. The product(s) being exported do not require any registration/approval of the Government Authority of the importing country.

I undertake to make available to the customs authorities any further supporting documents they require.

                                                                                                                By

Place:                                                                                 (Name of the Company/Exporter)

Date:                                                                                  (Signature)

Name & Designation of Authorised Officer

(with Company seal)

1. If only some of the goods listed on the document are concerned, they should be clearly indicated or marked and this marking entered in the declaration.

2. The Community, country, group of countries or territory, from which the goods originate to be indicated if the goods are not manufactured in India, in 1 above (if applicable)

3. Declaration at 1B and/or 2A to 2B to be scored out if not applicable for the goods/consignment.

Minutes of meeting with GS1India at Mumbai on 6.2.2014

Summary of discussion for meeting held on 6^th Feb 2014 organized by Pharmexcil between Pharma Industry representatives, GS1 India and Pharmexcil in Mumbai:

GS1 India gave a presentation on the packaging concepts globally followed and a comparison of that with the present packaging definitions as per DGFT   notification dated Oct 2013. Pharmexcil facilitated a discussion with the representatives of the industry on the present issues faced and to have consensus within the industry on definitions of  various levels of packaging seen as primary, secondary and tertiary etc.. The points of discussion are as follows:

Sl No.	Subject	Point of Discussion	Action Plan
1	Mono carton	·   In the meeting the present understanding of primary packaging and mono carton as per the DGFT notification of October 2013 was discussed ·   GS1 presented the Global definition of packaging and its variation with the present definition followed in India (for  primary, secondary and tertiary level packaging) as per the above notification ·   The industry agreed to align with the Global definition of primary and secondary packaging ·    As per the Global definition, any carton, consisting 1 unit or more than 1 unit of vials/strips/bottles including mono carton will be defined as secondary packaging (except shipper level which is tertiary) ·   As per the Global definition, each vial/strip/tube etc. is treated as primary having direct contact with the drug	Facilitate the implementation of the same through notification change by taking it up with DOC and DGFT
2	Implementation on Primary Packaging	·  Industry expressed concern on the implementation of barcoding on the primary packaging such as vial/strip/tube etc. due to ground level challenges faced ·  Industry requested to defer the date of implementation on primary level packaging ·	·  Representatives from the industry were asked to send their concerns and challenges to Pharmexcil with possible solution by 10th of Feb 2014. ·  Pharmexcil to consolidate and take it up with DOC/DGFT
3	Illustration through images in Implementation Manual	·   Industry expressed concern that the understanding of packaging definitions are not uniform across all stakeholders ·   Industry suggested that in the implementation manual, illustrations for different packaging levels to be provided with the help of images to facilitate clear understanding among the stakeholders	GS1 India to prepare the manual after the amendments on the packaging level
4	Stickering on Primary and Secondary level packaging	·   Industry wanted feedback whether stickers are allowed for barcoding on pharma products (primary and secondary) for exports. It is under the purview of DCGI	DCGI is to be  approached for clarification.
5	Barcoding on Small Packaging	·   Challenges for barcoding on small packaging was discussed ·   Industry wanted suggestion for barcoding on small products where there is space constraint	Industry can send the samples to GS1 India for advice. However final decision/approval to be taken from respective authority.
6	Awareness to Customs on DGFT barcoding notification	·   Industry felt the need for creating awareness among custom officials and update them on the DGFT mandate for uniform understanding of packaging level definitions for smooth flow of exports	Pharmexcil to coordinate for creating awareness within custom officials and GS1 India shall assist them
7	Country Specific Requirement	·   Industry wanted a clarity whether barcoding as per DGFT mandate can be over ruled in case there is a specific requirement from the importing country ·   It was pointed out that only if there is a regulation from the importing country regulator it shall be allowed to comply .	·   Industry was asked to provide the mandate/document of the importing country regulator requirement of the importing country  to DGFT / Customs officials for getting exemption
8	Merchant Exporter	·   Merchant exporters requested clarification on complying to the  primary and secondary packaging of the DGFT notification	·      The recommended option is to ask  the   Manufacturer to implement  barcodes as per DGFT notification while supplying to merchant exporters. Incase manufacturer do’s not then merchant exporter has to implement  at their end before exporting  them

INTERACTIVE MEETING WITH GS1 INDIA AT MUMBAI ON 6th FEB, 2014 FROM 1100 HRS TO 1300 HRS REVIEW OF THE STATUS OF MONO CARTON

Dear Sir / Madam,

We wish to inform our members that GS1 India is in the process of reviewing the status of Mono carton for implementation of Bar code system as per DGFT notification.

 As members may be aware, on the representation of Pharmexcil, Government of India, has notified the Mono cartons containing strips / vials / bottles   as Primary level packaging vide PUBLIC NOTICE NO. 31(RE-2013) / 2009 - 2014, Dated 17th October, 2013.

Many companies are seeking clarifications on the container to be considered as Mono carton and Government of India has directed GS1India to discuss with the Industry and submit report on this issue.

In view of the above, Pharmexcil is convening a meeting of the stake holders with GS1 India representative to discuss on the subject on 6th Feb, 2014, at The Orchid Hotel, Nehru Road, Vile Parle East, Adjacent to Domestic Airport, Mumbai - 400 099. Tel: + 91-22-26164040 from 1100 hrs to 1300 hrs.

Members are requested to participate in the meeting and get the necessary clarifications on implementation of trace and track system and also present their opinion on the status of Mono carton. The meeting is restricted to first 30 members on first cum first served basis. Members may send their issues / suggestions on the bar coding to Pharmexcil well in advance to ensure clarification from GS1.

 There will be no registration fees for attending this meeting. However, pre-registration is necessary. Please send the details of the participant and points/ suggestions for discussion tord@pharmexcil.com  with a copy marked to romumbai@pharmexcil.com.

With regards,

Raghuveer Kini

Executive Director

Clarification on importing country mandate

Clarification asked on the following: 

To our understanding Indian authorities have already implemented specific requirements for serialisation with respect to products which are exported. 

What are the exact requirements when a product is exported out of India to a country which has another regulation (e.g. France)? 

In the secondary packaging section of the guidelines released by GS1 India it states that: 
In case the importing country has mandated a specific requirement, the exporter can adhere to the same and it would not be necessary to comply with the above requirement. 

The questions are: 
1) If the import country has only a requirement to serialize the secondary packaging, would the Indian requirement for primary and tertiary packaging still apply? 
2) If the import country has only a requirement to mark the product with datamatrix with GTIN, batch, expiry but not serial number, do we have to print 2 datamatrix on the product (one to comply with the import country requirement and the second for the Indian requirement)? 

Clarification given by GS1 India:

As per the manual, If the importing country has any mandate on any levels of the packaging, then it can be followed. For rest of the levels DGFT mandate will apply.

Regards,

Bijoy Peter

GS1 India

DCGI to take up matter of barcoding for primary packaging with Commerce Min, Pharmabiz

DCGI to take up matter of barcoding for primary packaging with Commerce Min

Joseph Alexander, New Delhi Tuesday, January 07, 2014, 08:00 Hrs  [IST]

The Drug Controller General of India (DCGI) will take up with the Commerce Ministry the issue of barcoding for primary level packaging of pharmaceutical products which, the industry felt, would be virtually impossible for small products. DCGI Dr G N Singh, in a recent interaction with the industry leaders, said he would along with the Pharmexcil take up the matter with the Commerce Ministry and the concerned group of ministers. He also asked the industry leaders to give a detailed representation in this regard so that he can convince with the Health Ministry also. “Systems are made for the benefit of the industry. It there is a strong justification against a particular norm, the government was open to remove it,” he felt, while responding to the industry criticism that it would be practically impossible to fix bar codes on primary packaging. The DCGI, who stressed that the government was working for systematic changes in the regulatory system, also said that he had identified some key issues like test license and fee structure and would meet the industry soon to take the inputs. The Commerce Ministry had made compulsory implementation of the tertiary level barcoding on packaging from October 1, 2011 and secondary level barcoding for pharma exports from January 1, 2013. Though the barcoding for primary packaging was to be implemented from July 1, 2013, it had given one year extension and postponed the implementation till July 1, 2014. Instead of another year of extension, now the industry was pressing for the abolition of the rule, taking into consideration the practical difficulties. Backing the cause, Pharmexcil director general, Dr P V Appaji said the agency had been pursuing the issue for the industry and would again press upon the ministry to drop the proposal for primary packaging as desired by the industry.

Anvisa (Brazil) Approves Track & Trace System

The board of Brazil’s National Health Surveillance Agency, Anvisa, has approved a system that will be used to track drugs from manufacture to the time of sale.

Within three years, drug packaging will have a two-dimensional code, and the industry will need to have in place an electronic system to monitor each step of the package, from the factory to the pharmacy. In the case of prescription drugs, the monitoring will go further, with the ability to know who purchased a particular drug, explains Anvisa Director Dirceu Barbano.

The agency established an intermediate period of two years from the time of approval of the system to allow every drug company to submit a comprehensive report of traceability of at least three product lots that they have manufactured.

“The report will serve to demonstrate that the company has the system in place, and that it’s working. And the company would have an additional year to buy more equipment," Barbano said.

Another rule, yet to be issued, will define the process for communicating tracking information to Anvisa. The tracking data, says Barbano, should be created by the industry, possibly in partnership with pharmacies and distributors.

Nelson Mussolini, chief executive of Sindusfarma (Association of the Pharmaceutical Industry in the State of São Paulo), says the move brings certainty to the industry and the consumer. Mussolini said he believes it is possible to meet the deadline established by Anvisa, although there is some concern amongst manufacturers about the cost of the change and the availability of equipment necessary to establish traceability. There is no mention of passing costs to consumers, he said, since drug prices are controlled by the government.

The call for traceability was established by law in Brazil in 2009. In 2011, the agency gave up a proposal for traceability which involved the use of a stamp of the Mint, as it would have made products more expensive.

Source: http://www.raps.org/focus-online/news/news-article-view/article/4405.aspx

US Track and trace plans signed into law w.e.f. 27.11.2013

The US FDA has started work on a national track and trace system for pharmaceuticals after President Barack Obama signed the Drug Quality and Safety Act into law on 27/11/2013. The Drug quality and security Act of USA is available at the following link which enable  USFDA to formulate the track and trace system . 
 https://www.govtrack.us/congress/bills/113/hr3204/text
Source:
http://www.in-pharmatechnologist.com/Regulatory-Safety/Happy-Thanksgiving-US-track-and-trace-plans-signed-into-law?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright