This blog is created to help Pharmaceutical exporters to clear their doubts on Track and Trace system to be adopted
Thursday, August 7, 2014
Monday, June 30, 2014
DGFT P.N.No.62 (RE-2013)2009-2014 dt. 26th June 2014 - Bar code on Primary level pack - deffered
Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
Public Notice No. 62 (RE-2013)/2009-2014
New Delhi, Dated the 26 June, 2014
Sub: Procedure relating to tracking and tracing of export consignment of pharmaceuticals and drugs.
In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2009-14, as amended from time to time, and in supersession of the following Public Notices, Director General of Foreign Trade hereby prescribes the following procedure for tracking and tracing of export consignments of drugs and pharmaceutical products:
(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
(iii) Public Notice No. 87(RE-2010)/2009-2014 dated 22.12.2011
(iv) Public Notice No. 10(RE-2012)/2009-2014 dated 11.07.2012
(v) Public Notice No. 54(RE-2012)/2009-2014 dated 05.04.2013
(vi) Public Notice No. 31(RE-2013)/2009-2014 dated 17.10.2013
Director General of Foreign Trade
E-mail: dgft@nic.in
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
Public Notice No. 62 (RE-2013)/2009-2014
New Delhi, Dated the 26 June, 2014
Sub: Procedure relating to tracking and tracing of export consignment of pharmaceuticals and drugs.
In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2009-14, as amended from time to time, and in supersession of the following Public Notices, Director General of Foreign Trade hereby prescribes the following procedure for tracking and tracing of export consignments of drugs and pharmaceutical products:
(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
(iii) Public Notice No. 87(RE-2010)/2009-2014 dated 22.12.2011
(iv) Public Notice No. 10(RE-2012)/2009-2014 dated 11.07.2012
(v) Public Notice No. 54(RE-2012)/2009-2014 dated 05.04.2013
(vi) Public Notice No. 31(RE-2013)/2009-2014 dated 17.10.2013
- Every exporter of Drugs & Pharmaceuticals at the time of shipment shall submit, alongwith other required documents, the following:
- A copy of Certificate of Analysis issued by the manufacturer for the subject products; or
- A copy of Certificate of Analysis issued by approved laboratory of the importing country/ FDA; or
- A copy of Certificate of Analysis issued by a laboratory approved by Drugs Controller under Drugs & Cosmetics Act, 1940 and the rules made thereunder.
- (i) Exporters of pharmaceutical products will
adopt a track and trace system and incorporate its features for exported
medicines using barcode technology as per GS 1 global standards. The
following is needed to be done as detailed below:
a. Primary Level packaging requirement:
Incorporation of 2D (GS1 Data matrix) barcodes on medicines at strip/vial/bottle, etc. encoding unique product identification code (GTIN) and Unique Serial Number of the Primary pack.
b. Secondary Level packaging requirement :
Incorporation of barcodes (1D or 2 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Secondary pack. Mono cartons shall be treated as Secondary Level Packaging in line with prevalent global packaging nomenclature.
c. Tertiary Level packaging requirement:
Incorporation of barcodes (1 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Tertiary pack (shipper/carton).
(ii) The track and trace technology as per serial number 3(i) above will be effective as under:
(a) Primary Level packaging :- Effective date will be notified later.
(b) Secondary Level packaging :- 1st January, 2013 (already given effect to)
(c) Tertiary Level packaging :- 1st October, 2011 (already given effect to) - In case, the Government of the importing country has mandated a specific requirement, the exporter has the option of adhering to the same and in such a case, it would not be necessary to comply with the stipulations at serial number a, b & c of para 3(i) above and if an exporter is seeking to avail exemption from bar coding prescribed by the Government of India as above, the exporter is given the option to move an application to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) for this purpose, clearly specifying the nature of such an exemption in the interest of the exports from the country. Pharmexcil shall dispose of such applications on case to case basis with prior approval of Government.
- Under the track and trace system, manufacturers would be required to maintain serialized record of exported pharmaceutical products for a minimum period of six months after the expiry date of the product.
- Authentication features will be added in due course and integrated with the track and trace system and Government will set up a Central Portal for tracking and tracing exported pharmaceutical products.
- A self certification process has been mandated effective 15.05.2014, vide Public Notice No. 56 (RE-2013)/2009-2014 dated 01.04.2014 read with Public Notice No. 58 (RE-2013)/2009-2014 dated 15.04.2014. This shall continue to be applicable without any change.
- Effect of this Public Notice:
- The requirement of affixing bar codes on Tertiary Level and Secondary Level Packaging already implemented w.e.f. 01.10.2011 and 01.01.2013 respectively continue to be in force.
- The requirement of affixing barcodes on Primary Level Packaging was to be effective from 01.07.2014. Now this date has been deferred till a new date is notified.
- Earlier through Public Notice No. 31 dated 17.10.2013, mono cartons were to be treated as part of Primary Level Packaging. Now this has been modified to treat mono cartons as Secondary Level Packaging.
Director General of Foreign Trade
E-mail: dgft@nic.in
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)
Bar Code Implementation on Primary level Packing for Export Purpose - Deffered
Ref: PXL/H.O./CIR-009/2014-15 Date: 13.05.2014
Hyderabad
To,
All the Members of Council,
Dear Sir/Madam,
Our Council members had the unique privilege of interacting with the Commerce Secretary, Shri Rajeev Kher, IAS, during the CEO interactive meeting at Hyderabad on 28th April 2014.
Council had been taking up with the Department of Commerce, Government of India on several occasions regarding the difficulties faced by the members in implementing the Bar Code on Primary Level packaging which is scheduled for commencement from 1st July 2014.
It is with great pleasure, we would like to inform the members that in view of the presentations by the Council as also by members, Commerce Secretary has informed the august gathering that implementation of Bar Coding on Primary Level packing for export purpose has been kept under suspension till further notification. We understand that official notification in this regard is under finalization by Department of Commerce. Members may kindly note the same.
This is for the kind information of our members.
With regards
Raghuveer Kini
Executive Director
Hyderabad
To,
All the Members of Council,
Dear Sir/Madam,
Sub: Bar Code implementation on Primary Level Packing for Export Purpose - Deferred..
Our Council members had the unique privilege of interacting with the Commerce Secretary, Shri Rajeev Kher, IAS, during the CEO interactive meeting at Hyderabad on 28th April 2014.
Council had been taking up with the Department of Commerce, Government of India on several occasions regarding the difficulties faced by the members in implementing the Bar Code on Primary Level packaging which is scheduled for commencement from 1st July 2014.
It is with great pleasure, we would like to inform the members that in view of the presentations by the Council as also by members, Commerce Secretary has informed the august gathering that implementation of Bar Coding on Primary Level packing for export purpose has been kept under suspension till further notification. We understand that official notification in this regard is under finalization by Department of Commerce. Members may kindly note the same.
This is for the kind information of our members.
With regards
Raghuveer Kini
Executive Director
Tuesday, April 15, 2014
Amendment in the date of effect for implementation of Self-certification
PUBLIC NOTICE NO.58(RE-2013)/2009-2014
Dated 15th April, 2014
Dated 15th April, 2014
Amendment in the date of effect for implementation of
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, as amended from time to time, Director General of Foreign Trade hereby makes following
amendments in Public Notice No.56(RE-2013)/2009-14 dated 01.04.2014:
2. Through Public Notice No.56(RE-2013)/2009-14 dated 01.04.2014 it had been notified that
with effect from 01.04.2014, export of pharmaceuticals and drug consignment would be
permitted through a self-certification process.
3. Now, it has been decided that the date of effect for implementation of Self-certification
regarding compliance of bar-coding requirements on secondary and tertiary level packaging on
export consignment of pharmaceuticals and drugs as mentioned at Para 3 of Public Notice
No.56(RE-2013)/2009-14 dated 01.04.2014 shall be 15th May, 2014. However, all those
consignments which have been got cleared as per Public Notice No.56(RE-2013)/ 2009-14 dated
01.04.2014 till date shall be treated as valid.
4. Effect of this Public Notice:
The effective date of Public Notice No.56(RE-2013)/2009-14 dated 01.04.2014 has been
amended to 15.05.2014.
Sd/-
(Madhusudan Prasad)
Director General of Foreign Trade
F.No.01/91/180/648/AM 09/Export Cell
Issued by:
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
New Delhi
** ** *
Thursday, April 3, 2014
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
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 1st October, 2011 as per Public Notice No. 59 of 30.06.2011.Similarly on
secondary level packaging this has come into effect from 1st 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 1st 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 1st 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)
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.)
(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:
ii. Public Notice No. 59
(RE-2010)/2009-2014 dated 30.06.2011 (applicable for tertiary level packaging)
iv. Public Notice No. 10 (RE-2012)/2009-2014
dated 11.07.2012 (applicable for secondary level
packaging)
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.
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)
Place: (Name of the Company/Exporter)
Date: (Signature)
Name &
Designation of Authorised Officer
(with Company seal)
(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.
Wednesday, February 26, 2014
Minutes of meeting with GS1India at Mumbai on 6.2.2014
Summary of
discussion for meeting held on 6th 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:
Friday, January 24, 2014
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
Thursday, January 9, 2014
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)?
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
Tuesday, January 7, 2014
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. |
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