Pharmaceutical manufacturers are lagging behind distributors in testing electronic connections with trading partners as the November 2023 deadline for having these systems in place under the Drug Supply Chain Security Act (DSCSA) approaches, according to a recent survey by the Healthcare Distributors Alliance (HDA).
Counterfeiting can apply to both branded and generic products, Counterfeit medicines pose significant health risks to patients which results in unnecessary morbidity and mortality. At 10% of global trade, counterfeiting affects many countries, causing serious downstream expenses and resource shortages.
The security of the pharmaceutical supply chain can be strengthened by blockchain platforms like ours to achieve compliance to fight counterfeiting. Counterfeit drugs can lead to drug recalls and liability suits. In addition, brand loyalty is compromised as consumers perceive additional risks when using a company’s products. An effective anti-counterfeit strategy avoids this and ensures patient safety.
The implementation of anti-counterfeit technologies is the prominent preventive measure . In addition to providing authentication, they make the production of a convincing copy of a drug more difficult and costly.
Our platform provides T3 data as defined Under the Drug Supply Chain Security Act (DSCSA), for the medicines transacted including their change of ownership. The T3 data requirements include sending the Transaction history (TH), the Transaction information (TI), and the Transaction Statement (TS).
We provide a time track and traceability feature to achieve your compliance goals of product identification at the package level for each package, unit-level traceability (i.e., serialization), with the product’s standardized numerical identifier (SNI) including FDA NDC code, a lot number, and expiration date as per DSCSA rules.
As per DSCSA, all supply chain stakeholders must verify saleable returns before they can be reintroduced to the supply chain; they do this by verifying the drug’s unique product identification number, our platforms help you to comply in real-time for unit-level returns with TI/TS information of all your products.
With our platform, you can achieve drug regulatory pharma compliance for countries such as United States (DSCSA), European Union (FMD), India (DAVA), Brazi (Anvisa)l, South Korea, Saudi Arabia helping you enable patient safety and combat counterfeit drugs from entering the supply chains.