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India supply chain cos acknowledge importance of US FDA draft norms on drug distribution security at package level

Nandita Vijay, Bengaluru
Tuesday, August 3, 2021, 08:00 Hrs  [IST]

Indian supply chain and related companies see that US FDA draft guidance on enhanced drug distribution regulations at the package level will add extra touch of security to the pharmaceutical exports into the US.

The guidance, according to the US FDA, is intended to assist supply chain stakeholders, particularly trading partners, for enhanced drug distribution safety at the package level under section 582 of US FDA Act, effective from November 27, 2023.

In fact, the guidance replaces the DSCSA (drug supply chain security act) to be phased out since 2013 to improve the oversight of trading partners.

While the regulatory authority mandates use of verification, inference, and aggregation, it points out that trading partners need to ensure the quality of medicines exported, protect the pharmaceutical distribution supply chain integrity. The transaction information needs to be secure and interoperable in an electronic manner. Use of security features on shipping units like homogeneous cases or 160 pallets of product will help indicate when products could be tampered, or previously unsealed, or damaged, rendering it suspect. It supports use of anti-counterfeiting technologies like physical-chemical identifiers (PCIDs) in solid oral dosage forms.  

With US being a major market for India’s generic drugs, Swati Babel, CEO, PrimaDollar India, a leading supply chain financing platform, stated, “Our pharma industry has been using serialization software for a long time. The recent US FDA recommendation suggests that drug supply chain must exchange information about drugs and its handing details to the US which would synchronize the process to enable transparency and create a robust supply chain.”

Babel pointed out that exports consignments must have 2D barcodes which is done through serialization software after which goods are bought and sold, encoded with product identifiers to allow precise tracking and reporting. Although the supply chain process becomes a long-drawn one, yet we see that it enhances drug distribution security and helps to identify suspected products, said Babel.

According to Debasish M Banerjee, director, Creative Solutions, a one-stop pharma product design solutions provider for international markets, lack of harmonized regulations between the DGFT and importing countries can lead to confusion about export product labeling. Potential issues can be duplicate GTIN on packaging levels leading to risk of incorrect receiving or picking of product from barcode to scan which would lead to stoppage of products in the supply chain due to master data discrepancies. Further, use of SSCC & SGTIN can lead to incorrect receiving or picking of product because of aggregation data risk that exist having 2 serial numbers on the same unit of packaging. Non-conformance with HDA barcode guidelines can decrease the efficiency of the supply chain resulting in increased cost, product delays & potential shortages, he noted.

Indian pharma can meet the deadlines that are fast approaching for enhanced drug distribution regulations, to protect data, from falsification, malicious attacks, and breaches. The DGFT should harmonize its implementation with that of the US DSCSA and the European Union’s Falsified Medicines Directive (FMD). A solution should be designed from the bottom up: line level to the cloud, without retrofitting of regulations to a commercialized solution that carries the risk of undetected errors. Those supplying to the US should consolidate their site and production-line reporting, obtain exemption from Pharmexcil for correct DAVA portal reporting, and set up master data sets, including GTIN, said Banerjee.

 

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