Faced with delays at ports and possible product recalls, industry hopes the DGFT will fix the issues with the DAVA portal as well as issue clarifications.But with just three months to go to the mid November deadline, time is running out fast.
India’s serialisation and traceability journey has been a series of extensions and delays. This defines the Government of India’s dilemma of dealing with a very diverse sector, comprising companies of all sizes. The latest extension came this May.
The Directorate General of Foreign Trade (DGFT) public notice dated May 9 specifies that export of drugs manufactured by SSI and non-SSI units, manufactured on or before November 15, 2018, are exempted from maintaining data in the parent-child relationship for three levels of packaging and uploading this data on the central DAVA portal. All drugs manufactured after this date can be exported only if both tertiary and secondary packaging carry barcoding as applicable and the relevant data is uploaded in the DAVA portal.
For more than two years, pharma companies have expressed significant concerns regarding the DAVA database, including in a detailed white paper published in May 2017 by RxGPS, an alliance of pharma stakeholders. (See story: http://www.expressbpd.com/pharma/pharma-technology-review/making-sense-of-serialisation/389701/)
Will the two sides, DGFT and pharma companies, use this extension of six months address these issues?
As is to be expected, companies have their expectations and wish list. For example, Aditi Kare Panandikar, Managing Director, Indoco Remedies says, “It is essential that the DGFT audit and certify the line level and software level vendors for compliance. This will be a major help to pharma companies in vendor selection. The DGFT authorities should also finalise the minimum set of machinery for compliance and also publish the same, so that small/ mid-sized pharma companies know where to invest, as vendors confuse them with requirements.”
Shivaji Chakraborty, Asst General Manager, Packaging Development, Fresenius Kabi Oncology suggests three steps to be taken during this period of delay for DGFT to address the technical problems. The first step would be to organise meetings with industry to understand the difficulties faced by the companies and take actions accordingly. The next step should be to evaluate the requirement and come up with a proposal in line with global requirements. For example, in the case of tertiary level packaging, the US requirement is to print the serial shipping container code (SSCC) number (an 18-digit number used to identify logistics units) on the logistic pack, irrespective of homogeneous and heterogeneous pack while India’s requirement is for the SSCC number, along with the GTIN and other batch detail. The third step he suggests is that DGFT sets up a technical support team.
Equipment manufacturers like Gaurav Mohite, Product Manager, Global Track & Trace Portfolio, ACG are hoping that pharma companies will use the extension to “gear up and set-up the process to enforce critical aspects of serialisation within their organisation. As per the market feedback, most customers have been struggling in implementing complete control over the process, so as to ensure that the correct data gets uploaded to DAVA portal.”
Data security a must …
Kare Panandikar echoes most of her peers when she says that while the pharma industry has welcomed the DAVA system, there are still a few concerns like the non-availability of a good knowledgeable vendor for serialisation, the very high cost of equipment procurement and the non availability of trained resources for serialisation qualification and implementation. She also points out that many vendors claim to be compliant, however, there are very few who are actually capable of complying with the regulations.
Data that need to be uploaded to the portal, include details of the product, distribution point, batch, production, movement and aggregation but Chakraborty points out that there is lack of clarity about distribution point and movement details. (See box: Challenges faced on DAVA portal and some suggested solutions)
Overriding all of these concerns, is the possibility that this data could be visible to other companies and the lack of technical support to address these issues.
ACG’s Mohite too echoes this point, saying, “Considering the increase in cyber threats globally on databases and the potential manipulation of the market perceptions by some organisations using this data, the data security and integrity becomes one of the key concerns for any organisation.”
..but what about “dummy data”?
DGFT’s requirement that manufacturers upload “dummy” or fake serial numbers for primary packages (i.e. individual vials, blister cards, or bottles) that are not serialised is possibly the most confusing requirement. Since the DAVA system requires the upload of serial numbers for these primary packages, DGFT advised manufacturers to upload “dummy” or fake serial numbers for primary packages that are not serialised.
As a result, millions of fake serial numbers are being added to the DAVA database. There are concerns that these fake serial numbers could be applied to counterfeit drugs destined for countries all over the world.
“Dummy upload will not serve the purpose of traceability. This will increase cost to the company, as these numbers, if saved on the external server, will be charged,” points out Kare Panandikar. This use of serial number identifiers along with the requirement that serial number identifiers be unique at the company and not the product level will result in large manufacturers depleting serial number data pools as well, point out some industry sources.
Chakraborty minces no words when he says, “Dummy serial numbers is a data integrity issue. Serial numbers available in the database but physically not present may lead to confusion. And secondly, at present it may not be misused, but once authentication is implemented, the dummy serial numbers can be misused by the counterfeiter.”
On the other hand, some observers see this issue as a step in the journey and do not seem too perturbed. “We believe uploading “dummy” or fake serial numbers for primary packages that are not serialised is just a step towards making DAVA portal equipped for future primary packaging implementation. In our opinion, when DGFT enforces primary serialisation, the data handling and management requirements for DAVA are going to increase drastically.”
Industry sources list more technical challenges that made it difficult to use the DAVA system and export to waiting countries. For example, DGFT requires the use of a product numbering scheme that is inconsistent with global data standards. As a result, manufacturers are forced to choose between changing their entire numbering scheme—a cost that cannot be justified—and applying multiple product numbers to packages. The latter has caused significant operational challenges in countries of import and slowed or stopped the distribution of pharmaceuticals made in India.
Further, manufacturers seeking exemptions from the export requirements for product destined to countries with existing traceability requirements (permitted under the law) are forced to apply for exemptions product by product. This not only slows the process, but can create confusion if product exemptions have not yet been approved—leading to a situation where a product must comply with two different sets of serialisation and traceability requirements. The suggestion is to exempt all products exported to markets with existing regulations, which can alleviate this burden and confusion.
Safety and security
There have been questions on the safety of the DAVA database in terms of controlling access to the system and data to legitimate users and protecting data from competitors. There are concerns that data uploaded to the DAVA system is also unsecured: manufacturers (or any other entity with access to the system) are currently able to see product and batch information from other contributors, including competitors, which could be used for anti competitive purposes—or to make counterfeit product look legitimate, and either outcome could position India as an undesirable place to do business.
Users seem divided on this front. Chakraborty of Fresenius Kabi Oncology doubts that the DAVA database is secure as anyone having the digital signature to log-in to DAVA portal can access the data of the competitors. “Although we have not yet faced any problem, but this easily available data can be misused by the counterfeiter.”
Kare Panandikar of Indoco Remedies on the other hand opines that it is secure as one has to digitally sign to login to the portal. In Mohite’s assessment too, the dummy data currently uploaded on the DAVA portal cannot be used for authentication purpose, which means that at this point the misuse of the dummy data cannot arise.
But Kare Panandikar acknowledges that her company has faced a significant downtime of the DAVA systems. “Most of the time the website could not be accessed while uploading data.”
Mohite also recalls that initially when most customers started using DAVA portal, they faced some problems regarding access and user control. “We learnt that the DAVA team had also gone through the learning curve and were able to consolidate the portal to serve the DGFT requirements and manufacturer expectations.”
A dip in exports
But the situation has already negatively impacted pharma exports from India. At Indoco Remedies, Kare Panandikar says,“Urgent export consignments were kept on hold for more than 15 days at the ports. This led to decrease in the company’s export revenues and also shortage of the products at the customer’s end.”
Customers faced with such disruptions in supply could choose to switch to suppliers from other countries. Regulators in other countries too could choose to play safe, and subject consignments from India to great scrutiny, due to data security concerns. Rebuilding trust with clients and regulators will take time and will impact revenues for quite a few quarters or even years.
Differing definitions leading to product recalls
The complexity of serialisation is that each country follows different definitions. For example, the Indian regulations for exports define three packaging levels for serialisation: primary package (the serialisation of which is optional), secondary package and tertiary package. Chakraborty says that in many other countries, the requirements are based on the discrete packaging levels driven by trade. In the US, the saleable unit may be a primary package or a secondary package. In the European Union, the saleable unit is always the secondary package. As a result, a single packaging level is often understood and regulated differently in different countries.
The confusion related to packaging level terminology is especially challenging for products exported from India to a country that has its own serialisation requirements. Although India’s exemption for exports to such a country provides some relief, Chakraborty points out that confusion remains with regard to India’s requirements for tertiary packaging, which is not covered under such exemption.
GS1 defines a tertiary package as the logistical unit that is shipped, the shipper, carton, case or a pallet that contains one or more primary/ secondary levels of packaging. This means different or multiple levels of packaging can be “tertiary” packaging. This has created significant confusion, and as a result, he says labeling for product leaving India as “tertiary” packaging varies widely. In some instances, product exported from India to the US has carried two different GTINs. In other instances, the same GTIN (which is intended to be specific to a single packaging level) is affixed to multiple packaging levels. These types of discrepancies can actually stop the movement of the product and, also can lead to recall, cautions Chakraborty.
Gearing up for the next phase
Inspite of the several challenges, serialisation and traceability is no longer a choice but a necessity driven by regulation. As Mohite points out , “We know that 70 per cent countries had either finalised or are at the draft stage regarding their track and trace regulation for pharma industry. This situation in the global pharma market demands that Indian pharma manufacturers must take the implementation seriously and upload the data in DAVA portal.”
India is not the only country struggling with serialisation, which is possibly the most complex milestone to be navigated by the pharma sector across the world. It is now evident that such a project needs small, well planned steps rather than a leap into the unknown.
As Mohite points out, “Complete track and trace implementation is an extremely critical project and the Indian government has been able to successfully implement the serialisation and aggregation requirements with data reporting aspects in a phase-wise manner. Today, we can see many countries following a similar trend to implement track and trace capabilities in a phased manner.”
The next phase of India’s serialisation and traceability journey starts on November 15. The question is, will we be ready?