Abhijit Acharya, product manager, and Nathan Sigworth, ceo, PharmaSecure, outline the requirements for bar coding and serialisation on pharmaceutical packaging for products exported from India.
The Indian serialisation movement, which has been supported by the Directorate General of Foreign Trade (DGFT) Mandate, has proved an extremely important milestone in the history of serialisation. It has led to the first large-scale serialisation of packages, including even inexpensive products, in a cost-effective manner.
The DGFT Public Notice No. 21, released on 10 January, 2011, requires unique numbers and barcodes for every tertiary, secondary and primary package exported from India, according to GS1 standards. While producers are not expected to implement a complete track and trace system immediately, they are required to maintain or have a third party maintain a database of their serial numbers and the associated products. Over time, authentication and track and trace systems will be encouraged among manufacturers and distributors; serialisation will probably also be expanded to domestic products.
While producers are not expected to implement a complete track and trace system immediately, they are required to maintain or have a third party maintain a database of their serial numbers and the associated products
The original date in the implementation of DGFT serialisation was 1 July, 2011 for tertiary, secondary and primary packages. After Public Notice number 21, the DGFT took time to review and consider the industry feedback on the new regulations and re-consolidated the implementation timeline based on the inputs. This resulted in the deferrment and staged implementation of serialisation in the form of Public Notice number 59.
In this public notice, the DGFT encouraged the industry to start with tertiary packaging, which offers the least technical complexity towards implementation of the solution. Another important change was the reduction of the statutory information needed on the primary packages.
A strong reaction from the industry after the initial notice surrounded the technical complexity and challenge around affixing considerable additional information on primary packs (i.e. the final saleable item) due to lack of space and readability issues from foil packaging. The DGFT changed the mandate from incorporation of GS1 Application Identifiers 01, 10, 17 and 21 to only 01 and 21 on the primary pack.
In response to continued discussion between the Indian Government and industry about the complexity of implementing serialisation on secondary and primary packaging, the DGFT issued Public Notice number 87 on 22 December, 2011 giving the industry an extra six months to comply with the more complex types of serialisation. This clarified that while the Government would work with the industry to ensure quality implementation, it was sticking to its commitment to serialisation in a short timeframe.
There are four general approaches that companies are taking towards adherence with the guidelines:
1. Work with specialised system integrators with an India focus
These companies partner with hardware providers to customise solutions capable of meeting the requirements of the DGFT mandate and offer a suite of add-on services.
2. Complete the process in-house
Many companies have undertaken tertiary serialisation internally, but due to increased complexity and cost are looking to external providers moving forward.
3. Contract large international serialisation and track & trace providers
These providers incur more cost than the rest as both the software and, in many cases, the manufacturing lines have to undergo complex levels of automation for complete, seamless integration.
4. Contract hardware vendors for hardware and software
While the software is helpful in meeting the demand of the industry in time for tertiary deadlines, many hardware providers are forming partnerships with more robust software suites to offer integrated solutions for secondary and primary DGFT serialisation.
PharmaSecure is a software and technology company based in the US and India with partners around the world. A leader in serialisation, authentication and e-health technologies, the company has experience of putting in place coding that will protect 1.5bn packs exported from India this year. As PharmaSecure works with manufacturers in India, it not only provides the technology and service support needed to comply with DGFT regulations but also creates further value for the pharmaceutical industry through additional serialisation-based services.
authentication service
By means of PharmaSecure’s psID serialisation integration, unique codes can be printed on every drug package that comes off the manufacturing line. Once the drug package has a unique ID, then psVerify, Pharma-Secure’s authentication service, can be activated and consumers can verify the drug by sending the unique ID by text message or through a web portal and receiving an authentication response.
Built upon psVerify, psData then provides consumer level distribution analytics in real time. It monitors when and where each drug package is produced and when and where consumers and others in the distribution chain authenticate each package. This powerful data enables cutting-edge oversight and market analytics. Based on psData, psConnect is an e-health platform that facilitates two-way communication between manufacturers and consumers. A suite of innovative and user-friendly applications, psConnect enables consumers to access valuable information and services related to the drug they purchase.
