Track & Trace

The decision has been taken in order to curb the sales of spurious medicines. Furthermore, this will also help in checking the authenticity of the drug. The amendments to Drugs and Cosmetic Rules, 1945 which, once approved, will come into force from May next year.

The pharma MSMEs are already reeling under steep rise in prices of imported Chinese APIs; Besides, QR code is hardly effective in addressing spurious or adulterated API menace

You must’ve noticed a data matrix code on your prescription drugs containing a code and some alphanumeric numbers. Many countries across the globe have made it mandatory for pharma companies to generate and share this information. But a concept that was once confined to pharma brands has now become a significant trend in the retail sector. Brands across industries leverage serialization to generate unique product codes to fight counterfeiting and enable a transparent and efficient supply chain.

Two lots of blood pressure medication are being recalled over concerns that it has too much of an impurity, according to the U.S. Food and Drug Administration. According to the notice, while nitrosamines are common, “These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”

A packaging mix-up has led to the recall of a blood pressure medication and a second medication designed to lower the risk of having a stroke or serious heart problems, the U.S. Food and Drug Administration reports.

It's important for medical device manufacturers to have a clear understanding of nonconformances—often referred to as NCs—and how to properly manage them. Why? Nonconformances can have a significant impact on patient safety and the quality of care they receive. In addition, nonconformances can lead to increased costs, regulatory penalties, and recalls.

The pharmaceutical industry suffers an annual loss of around $150 billion due to the replacement of real medications with fake versions of them. In addition to costing consumers money, illegal narcotics endanger lives and cause harm to the reputation of trusted brands. And when it comes to medicines, consumer trust in manufacturing companies and the quality of their products plays a huge role. The lack of coordination and traceability of the drugs within the pharmaceutical supply chain is a contributing factor to the problem of counterfeit drugs.

With the theme of innovation in mind, in this blog, we examine two groundbreaking technologies to see how they stack up against counterfeiting. The onslaught of counterfeit products in the market has compelled brands to turn to security labeling technologies to protect their products. However, the technologies vary in protection performance.

Congress enacted the Drug Supply Chain Security Act (DSCSA) in late November 2013, with the aim of providing additional oversight of the drug chain of custody throughout distribution. As the last of several deadlines approaches, actors in the pharmaceutical supply chain are working hard to fulfill its mandates – and some are struggling to keep up. Here’s a look at what DSCSA compliance means, how the pharmaceutical industry is meeting traceability requirements, and how to be ready for the final step on the DSCSA implementation timeline as we look forward to 2023.

As we are all aware, the pharmaceutical sector does not stand still. In fact, it is characterized by multiple “blink-and-miss-it” moments, whereby changes in its entire infrastructure seem to be taking place daily. Never has this been more apparent than during the global COVID-19 pandemic. With major changes taking place in the supply chain to huge advancements in technology, the last 24 months have seen a seismic shift in the way that the pharma sector has had to adapt to the most intense pressure it has seen for generations.

The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failures.

Ensuring the quality and safety of a medicinal product is both a moral and a regulatory requirement across the biopharmaceutical (biopharma) value chain. Pharmacovigilance (PV) is a crucial mechanism for providing evidence to the biopharma industry and regulators of the long-term safety profile of medicines. Meanwhile, patient support programmes (PSPs) help patients manage their medication and disease outcomes more effectively and, in certain circumstances, can improve equitable access and provide early safety signals. A rising incidence of post-launch adverse event reports (AERs) and increasing expectation of more personalised, preventative, predictive and participatory (4P) medicine has coincided with advances in artificial intelligence (AI) technologies and data analytics. This conjunction increases the potential for post-launch strategies to increase safety, improve equity and enhance patient engagement and experience.

With GS1underpinning this digital framework, greater connectivity and data insights will pave the way for new possibilities. For businesses, this means unlocking new data that drives supply chain security, sustainability, and profits. But where does one start to win this prize?

Connected packaging isn’t the way of the future. It’s here now, and it’s being used by switched-on brands globally. Gavin Ger, Joint CEO and Commercial Director at Laava, shares three ways that brands use connected products to create brand value, convert interest and generate revenue.

QR codes are a type of barcode that can store information about the product, contact information for the company, or a URL. The QR code is scanned with a mobile device to access the information stored within. The codes are very versatile and can be used on any physical product or printed material. QR codes are not just useful for marketing purposes; they also help to keep products safe by providing consumers with additional product information and contact details, as well as helping companies track their inventory.

Even the best-designed, most colorful signs are lazy. They just hang around hoping someone will notice, and you’re never sure when somebody does. But what if potential customers could actually “talk” to you through your signs? Or any other printed information, like fliers, brochures, product labels, even business cards? Enter QR codes.

Innovation in consumer engagement takes another exciting step, as local Australian startup Cellr delivers not one but three exciting collaborative promotions with its smart packaging software solution.

Around 300 top selling drugs will have to print QR codes on the primary packaging labels in accordance with the government's plans of launching track and trace mechanism

DHL has released a trend report in cooperation with Accenture, a leading global technology consultant, on blockchain technology’s potential to transform the logistics industry. Global supply chains are notoriously complex, with a diverse set of stakeholders, varying interests, and many third-party intermediaries – challenges that blockchain is well suited to address. The report includes initial findings on a working prototype developed by DHL and Accenture, which tracks pharmaceuticals from the point of origin to the consumer, preventing tampering and errors.

Leveraging blockchain technology in the supply chain overcomes challenges with faster and leaner logistics in global trade, comprehensive transparency and traceability, and improved automated commercial processes backed up by smart contracts, which are agreements that are automatically executed by nodes once certain precoded conditions are fulfilled.

The HDA's annual Traceability Seminar is the premier industry event for all pharmaceutical supply chain leaders. We're an official sponsor, and our team will be there with our latest solutions for DSCSA compliance, including serialization, traceability, EPCIS, ATPs, and the VRS.

In becoming compliant with interoperable data exchange requirements under DSCSA, don’t overlook the pharmaceutical label itself. Missing case labels or faded inks can pose threats.

Nowadays, there is a flood of pharma companies in the market, every day news comes that fake medicine was caught from the shop of such city. Now the government is preparing to rein in this. From now on, whether a medicine is real or fake, you will be able to find out by scanning it from the mobile. In fact, the government is working on a track and trace mechanism, which will crack down on the use of counterfeit medicines.