Usha Sharma – Mumbai
The Directorate General of Foreign Trade (DGFT) has recently issued a public notice informing the pharmaceutical industry in India that barcode implementation on primary packages meant for exports has been pushed back and effective date will be notified later.
Commenting on the notice, Dr PV Appaji , Director General, Pharmaceuticals Export Promotion Council of India (Pharmexcil) said, “The Government has been very considerate of our request to postpone the decision on primary packaging. We have tried to explain the extreme difficulties involved in barcoding on primary packing in terms of technology, cost and approvals required by overseas FDAs for label modifications etc.”
Bhavin Mehta, Committee Member, Pharmexcil and Director, Kilitch Drugs said, “Barcode implementation on primary packages is a big concern and we feel the DGFT’s public notice is an outcome of our constant approach. It is good for the industry since primary bar coding is very difficult at this moment as not too many agencies provide these services. There are few service providers in this domain but technologically it is economically not viable.”
Nakul Pasricha, Chief Operating Officer, PharmaSecure mentioned, “The latest DGFT notification has two significant implications. Firstly, it delays implementation on primary packaging, giving manufacturers more time to address the operational and financial challenges of printing barcodes on strips, blisters, bottles and other packages. PharmaSecure has already been working with many of the large manufacturers in India to address these challenges, having successfully printed close to one billion codes on primary packages across plants in India. Therefore, we are confident this challenge can be addressed and we look forward to continuing to work to address it.”
While speaking about the second implication, Pasricha informs about the significance of barcode implementation on secondary and tertiary packages and says, “The second implication is the reconfirmation of the tertiary and secondary deadlines, which we have seen is already spurring manufacturers to fully implement the regulation on all their lines. This is a positive step as it will ensure that at these two levels, packages are protected.”
Mehta while explaining the glitches in the implementation process said, “To implement bar-coding on primary packages, it is very difficult due to size restrictions on ampoule and vials and other dosage forms.”
The date of effect for implementation of barcoding on primary level packaging was July 1, 2014 and now has been extended indefinitely. The Ministry of Commerce and Industry Department of Commerce, DGFT recently issued a gazette mentioning deferment in the date of effect for implementation of bar-coding on primary level packaging on export consignment of pharmaceuticals and drugs for tracing and tracking purpose. The notice also mentions that in case, the Government of the importing country has mandated a specific requirement, the exporter has the option of adhering to same and in such case, it would be necessary to comply with the stipulations at serial number a, b and c of para 3 (1) and if an exporter is seeking to avail exemption from bar coding prescribed by the Government of India, the exporter is given the option to move an application to 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 from the Government. Under the track and trace system, manufacturers would be required to maintain serialised record of exported pharma products for a minimum period of six months after the expiry date of the product. A self certification process has been mandated effective May 15, 2014 vide public notice and this shall continue to be applicable without any change.
Authentication features will be added in due course and integrated with the track and trace system and the Government will set up a central portal for tracking tracing exported pharmaceutical products.
While commenting on the future prospect of the implementation of bar-coding on primary packages, Mehta said, “In future, whenever the Government will re-think implementing (this technology), it will definitely discuss with the industry stakeholders and will arrive at a final decision after figuring out the issues which are associated with the implementation.”
Pasricha pointed out, “We are confident of seeing full compliance at all levels in the coming years.”