Monday, December 31, 2012

Pharmexcil's circular on Status of Barcode dt.31.12.12.


Dear Sir/Madam,

We would like to bring attention of our members to our circular dt. 24.12.2012 on the above subject.  As indicated in the earlier circular, Council has been following up with Ministry of Commerce/DGFT for extension of date of implementation for bar coding on secondary packing from the stipulated date of 1st January, 2013 by about 6 months.  The latest position/additional clarifications on this subject are given below:

i)                    Extension of effective date of implementation from 1st January, 2013 on secondary packing.

As per the latest discussions with Government today, it has been informed that Government is not considering to give any extension for implementation of bar coding on secondary packing.  Accordingly, bar coding on secondary packing would come into effect from 1st January, 2013.

ii)                  Clarifications on certain issues sought by members:

a)      Status of mono cartons – whether it is  primary packing or secondary packing?

There has been some confusion from the revised manual published by GSI. Pharmexcil has takenup the issue with GS1 and brought to their notice that the revised manual has created some confusion regarding status of mono cartons as secondary packing as against primary packing indicated in the previous manual.  After followup by Pharmexcil, GSI has revised the manual today and clarified that mono cartons would be considered as primary packing and therefore would not require bar coding on mono cartons (as requirement of bar coding from 1st January, 2013 relates to secondary packing only).  The revised manual of GSI is uploaded on our web site  

b)      Status of products manufactured  before January, 2013

The Government/DGFT vide policy circular No. 43(RE-2010)2009-14, dt. 25.10.2011   has earlier clarified with respect to bar coding on tertiary packing , that bar coding requirement for pharmaceuticals and drugs would be effective for products manufactured after effective date of implementation of bar coding .  Accordingly it is indicated that bar coding on secondary packing would become effective for those products manufactured on or after 1st  January 2013 only.

c)      Bar coding for bulk drugs

The Government/DGFT had already clarified vide policy circular No.48(RE-2010)/2009-14, dt. 28.11.2011 that bar coding requirement is applicable only in respect of finished pharmaceutical products i.e. medical formulations and not bulk drugs/APIs/Intermediates.

d)      Bar coding for merchant exporters and Ayush products.

Pharmexcil has requested GS1 to develop appropriate bar coding mechanism for merchant exporters for export of heterogenous drugs produced by varioius manufacteuerers  .  Pharmexcil has also requested Government for exempting small merchant exporters and Ayush product manufacturers for barcoding.  Pharmexcil is awaiting for the decision of the Government

e)      Bar coding on drugs meant for Government and physician’s samples

Pharmexcil has already taken up this issue with the Government and clarification is awaited.  In the absence of  clarification, it would be necessary to meet the bar coding requirement.

f)       Financial Assistance

Government has indicated that it would try to consider positively partial cost reimbursement to small exporters, provided Pharmexcil furnishes adequate data on this subject.  Members are therefore requested to provide data as per table given below:

a)      Name of the Company

b)       Export Turn Over of Formulations
(Rs. In crores)

Yr 2009-10
Yr 2011-12

c)      No. Of packing lines required for bar coding system

d)      Approximate cost of investment (exclusively for bar coding  purpose)

e)      Remarks ( if any)


Members are requested to kindly note the above position for implementation of bar coding on secondary packing.  Our Council would extend all possible help with timely representations to Government and early clalrifications (to the extent possible) to the members on this subject.

Thanking you,

Director General

Note: Additional Clarification:

g)System already mandated by importing country:

 Public notice No. 59(RE-2010) 2009-2014 dated 30th June 2011 of the DGFT  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 stipulations”  

Accordingly, if any country has already implemented a system for tract and trace purpose, the Indian exporter need not follow barcode system. Based on information received from members,  Pharmexcil will take up such issues with Govt. for  issuing exemption to such individual countries. Members are requested to inform council with details of such countries if any where the track and trace for pharmaceuticals products  is mandated. 

representation submitted by Pharmexcil for Merchant Exporters

Clarification by GS1 India on Mono carton

S Swaminathan
3:13 PM (2 hours ago)
to DGRaviRajeevMridulEmeAmitinfoGopal
Dear  Dr. Appaji,
Season’s greetings and best wishes for a happy and prosperous New Year!
As per our discussion with your officers, considering Indian export  packaging processes and practices and to facilitate the compliance on barcode requirements stipulated by DGFT , the primary level barcode  requirements  shall be applicable on mono carton.
The attached manual could be hosted on your website and made available to your members to clarify the same.
We have been regularly conducting awareness workshops  and webinars for Pharmaceutical exporters and  shall continue to undertake the same in future as well. Schedule for workshop and webinar for 2013 ( Jan – Mar) is available at:    and the same  could be communicated to your members.

Should any further technical clarification is desired your members they may approach our implementation team for support.
Thanking you.

With regards,

General Manager.
GS1 India.  

Monday, December 24, 2012

circular issued by Pharmexcil dt. 24.12.2012

Ref: PXL/H.O./CIR-115/2012-13                                    Date: 24.12.2012

  Important Information
Present Status on Bar Coding


Dear Sir/Madam,

We would like to inform that in view of scheduled time for implementation of bar coding on secondary packaging (effective 1.1.2013) is fast approaching, Council is receiving many calls enquiring about latest status of the same.  In order to update members on this important subject , we wish to inform as follows:

a)   As per DGFT Public Notice No. 10 (RE-2012/2009-2014 )dt. 11.7.2012, bar coding on Secondary packing and Primary packing is to be implemented with effect from 1.1.2013 and 1.7.2013 respectively.
b)   However, as industry felt that implementation on secondary and primary packing is difficult and involves huge financial burden on small and big companies, , Indian Drug Manufacturers Association filed a case in the Hon'ble High court at Chennai, some time back  , challenging the Public Notice issued by DGFT and the High Court had stayed the Public Notice. 

c)    When the  case was  pending before the Hon'ble High Court,  recently ,  Pharmexcil and IDMA met senior officials of  Department of Commerce, Government of India and explained  the problems in implementation of bar coding on secondary and primary packings. 

d)   While Department of Commerce appreciated the industry's concern, industry was also informed of the challenges / threat faced by Indian pharma due to adverse publicity by vested interests in international markets and it was made clear that Government is determined to implement the bar coding in order to create a brand for Indian Pharma in the international markets as a reliable source of quality Generics. Industry was also suggested to hold discussions with GS1, (the bar coding standards/ service provider)    and M/s.Wipro (the software company which conducted a detailed study on technologies/procedures and cost implications involved in the implementation on secondary packing). Accordingly, a meeting of these agencies with CEOs of industry was planned for 24th at Mumbai but the same could not be organized as GS1 and Wipro are not available till 2nd week of Jan 2013. Govt. has indicated that keeping in view the technical difficulties involved in primary packing, further adequate time/extension would be considered favourably. 

e)   Meanwhile, it is understood that on 21st Dec.2012, the Hon'ble High Court of Chennai pronounced the Judgment in the case in favour of Government of India, enabling the Government to proceed with implementation of the Public Notice.  

f)      As there are only a few days left before the scheduled date for implementing bar coding on Secondary Packing (1.1.2013) and industry is not fully geared up to implement the same, Council had submitted a representation before and also immediately after news of court judgement came to our notice on 21st Dec to the Department of Commerce and requested to give some time for implementation of bar coding on secondary packing.

g)    Though   DoC has always been very supportive and considerative to our requests made for promotion of pharma exports, there are likely delays due to normal year end holidays/leaves. However, council will try its best to get a favourable decision from the Govt. before 31st December 2012, so that exports will not suffer due to this issue.  

Note: All the Executives are requested to bring this important communication/information to the notice of their CEO/Managing Director.

We hope the above information is clear to the members.  Members may contact us at / or 040-23735462 for any further clarifications.

Thanking you,

Yours sincerely,

Dr. P V Appaji
Director General

Sunday, December 23, 2012

Madras High Court Judgement dt.21.12.2012

The above case was  posted for orders before Hon'ble  Mr.K.Venkataraman Judge.Court Hall No:11,Item No:27 at High Court of Judicature at Madras on 21.12.2012 .The order pronouns in favour of Ministry of Commerce and Industies,DGFT.The main petition is dismissed,after that I had applied for judgement order copy.It will get after vacation. 

Friday, September 14, 2012

W.P.No.29213/2011 status

Case Status:Pending
Case No.:29213
Year :2011
Respondent :UNION OF INDIA
Pet's Advocate :M/S.M.SRIRAM
Res's Advocate :M/S.M.RAJASEKARAN FOR R1
Category :General Miscellaneous
 Last Listed on: No Date Mentioned
Case Updated on :Sep 13 2012
Connected Application(s)
ApplicationTypeApplication NumberApplication Year
No Connected Matter(s)

Tuesday, July 17, 2012

dgft P.N. No.10(RE-2012)2009-2014

-COPY OFPUBLIC NOTICE NO.10(RE-2012)/2009-2014
Dated 11th
July, 2012
Deferment in the date of effect for implementation of
bar-coding on Primary and Secondary level packaging
on export consignment of pharmaceuticals and drugs
for tracing and tracking purpose.
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.59(RE-2010)/2009-14 dated 30.06.2011 read with Public Notice
No.87 (RE-2010)/2009-2014 dated 22.12.2011:
2. The trace and track technology as per serial number 2(i) a and 2(i) b of
Public Notice No.59(RE-2010)/2009-14 dated 30.06.2011 will come into
effect as follows:
(a) Primary Level packaging - With effect from 1st
July, 2013
(b) Secondary Level packaging - With effect from 1st
January, 2013.
3. Effect of this Public Notice:
Earlier the requirement of affixing barcodes on Secondary level  and
Primary level packaging was to come into effect from 01.07.2012 and
01.01.2013 respectively. Now this time limit is being extended by 6
months each.
(Anup K. Pujari)
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

Wednesday, July 11, 2012

Legal notice to DGFT dt.26.6.2012

VeR aFsi ru Partner-Legal --. -Imil t - r Ramesh Venkatachalapathy M.A., L.L.M. lChrcago Kent College of Law) ADVOCATE

To                                                                                                                 Dt:26.06.2012
The Directorate General of Foreign Trade
Udyog Bhavan H-Wing, Gate No.2, Maulana Azad Road New Delhi - 1 10 01 I .


Sub: W.P.No.2921a3n d 29214o f 20ll - Pharmaceutical Industry and Indian Association-v s- Union of India,R Secretaryto Government & another-Reg.

 Confederationo f Indian Drugs Manufacturers On behalf of our client IWs. Confederationo f Indian Pharmaceutical IndustryI SSI and Indian DrugsM anufacturer'As ssociationw, e have filed the aboveW rit Petitionb eforet he Hon'bleH igh Courto f Madrasp rayingf or issueo f Writ of Certiorarit o call for the entirer ecordso f the respondentisn connection with the impugnedn otificationo f the 2ndr espondendt ated3 0.6.2011in Public NoticeN o.59 (RE-2010)12009-20m14o diffing the notificationi n PublicN otice NO.21( RE-2011)12009-20d1a4te d1 0.1.2011a nd quasht he said notifications dated1 0.1.201a1n d3 0.6.2011. On 19.12.2011F,I isL ordshipM r..Iustice.N.PaVual santhakumahra dp assed interimo rdersi n the abovew rit petitionsg rantings tatusq uo as on 19.12.201t1o be maintaineda nd listed the mattera fter 3 weeks. Mr.M.RajasekaranSop ecial StandingC ounsel-S PCCG( SpeciaSl tandingC ounselt)o ok noticeo n yourb ehalf. Subsequentot our private notice, you have issueda nothern otificationd ated 22.12.201i1n PublicN oticeN o.87( RE-2010)12009-20N1e4w, Delhi,m odiffing the earlier notification which is the subject matter of writ petition pending before the Hon'ble High Court of Madras.

 As the matter is pending before the Hon,ble High Court of Madras and interim orders are granted, any further modification without leave of the courr. Kindly refrain from issuing any orders till disposal of the writ petition. Inpsiteo f this notice,i f you rely on notificationd ated2 2.12.2011in public Notice No.87 (RE-2010y2009-2014N,e w Delhi, without leave of the Hon,ble High Court, Chennai. Under instnrctionsf rom our client, we will constraint o initiate contempt proceedings and making you personal liable for all consequences thereto.
 nffi Sffiffir;

Monday, July 2, 2012

Madras High Court cases status

Case Status:Pending
Case No.:29214
Year :2011
Respondent :UNION OF INDIA
Pet's Advocate :M/S.M.SRIRAM
Res's Advocate :M/S.M.RAJASEKARAN FOR R1
Category :General Miscellaneous
 Last Listed on: No Date Mentioned
Case Updated on :Dec 21 2011
Connected Application(s)
ApplicationTypeApplication NumberApplication Year

Case Status:Pending
Case No.:29213
Year :2011
Respondent :UNION OF INDIA
Pet's Advocate :M/S.M.SRIRAM
Res's Advocate :M/S.M.RAJASEKARAN FOR R1
Category :General Miscellaneous
 Last Listed on: No Date Mentioned
Case Updated on :Dec 21 2011
Connected Application(s)
ApplicationTypeApplication NumberApplication Year

No Connected Matter(s)