Even as the November 2017 deadline for implementation of second phase of US Drug Supply Chain Security Act (DSCSA) is approaching fast, approximately 50 per cent of Indian pharma companies are under pressure to lose their US market share due to their inadequacies to comply with pharmaceutical serialization regulation and traceability.
DSCSA is being implemented in three phases starting from January 1, 2015 through November 27, 2023.
Phase 1 is already effective since January last year and enforcement started from May 1, 2015 wherein manufacturers are accountable for Product Tracing, work with Authorized Trading Partners, Verification (Transaction Information TI and Transaction History (TH), Authorized Distribution of Records (relating to the distribution of drug samples) and compliance with Uniform National Policy.
Phase 2 starts from November 27, 2017 wherein manufacturers are accountable for product tracing, product identification, suspect product, requests for verification and saleable returns product. manufacturers have to apply a new product identifier 2D datamatrix code on saleable packs of all of their prescription drugs in the first phase before November 2017. Product identifier containing standardized application identifiers (01) (17) (10) and (21) which uniquely identifies the GTIN, expiry date, batch number and serial number for each saleable pack. 2D Datamatrix shall carry both machine-readable data as well as human readable information which is encoded in the 2D Datamatrix. From 2018, the same is applicable for repackagers, and from 2019 it is applicable for wholesale distributors and from 2020 the same is applicable for dispensers in the as-mentioned sequence.
The DSCSA will have tremendous benefits in terms of consumer safety, protecting pharmaceuticals from fraud and counterfeiting and improving product’s efficiency.
Serialisation of saleable packs (bottles) to pallets of pharmaceuticals mandated by DSCSA will immensely affect supply chain of pharma business. Indian companies, exporting to the US market will have to implement a slew of upgrades of existing lines and make additional investments into aggregation lines and reporting software to fulfill US DSCSA mandate. A chunk of companies does not have adequate space at manufacturing plants to put in place serialisation system. 50 per cent pharma manufacturing plants need to expand their packaging space to incorporate serialization and aggregation workstation unit. Besides, the warehouses, logistics and distribution set ups also carry out repackaging works and will need re-aggregation units within these facilities, said Arjun Guha Thakurta, director-operations, Life Science Consulting Pvt Ltd, a Conval Group company.
A majority of Indian companies, faced with space crunch at manufacturing site, are encountering hurdles to comply with serialisation requirements at level 3 (site level software and hardware. Master data such as customer, product and work order information are generally managed in this layer) and level 4 i.e business logistics systems, said Thakurta.
They have so far put in place serialisation at first and second line levels. Level 1 encompasses line level systems such as printers, scanners, cameras, code readers and controls. Level 2 denotes line level control systems consisting of software that controls data, serial number management. The software also aggregates data across all layer 1 devices on a specific packaging line, he said.
In order to make changes in the facility layout of the packaging area, the companies have to stop production, carry out civil work, replace HVAC system, ensure re-qualification of the packaging hall and subsequently implement track and trace system. This will entail additional investment and loss of production.
In a bid to save on cost, most small and medium Indian companies are opting for local vendors over global suppliers which cost generally 30-40 per cent higher than local supplier. Local suppliers lacking knowledge of GxP data integrity, compliance mandates of US FDA and EU, the Indian pharma company is very likely to fail catering to the needs of the companies, said director, Life Science Consulting.
As per the US DSCSA mandate, manufacturers, repackers, wholesale distributors need to provide applicable TI, TH, TS not later than one business day, not exceed 48 hours after receiving request for information from US FDA or other appropriate federal or state official in the event of a recall or for the purpose of investigating a suspect product.
Without putting in place effective serialization solutions from level 1-4, manufacturers are not able to respond to the request of wholesalers and Repackers within stipulated time, he concluded.