July 2020 - rfxcel.com

India Pharma News: FDA Recalls, COVID-19 Vaccine & Ideas Summit 2020

The last time we checked in on the India pharma supply chain, the country had announced restrictions on the export of active pharmaceutical ingredients and medicines, launched its national iVEDA portal for drug authentication and track and trace, and changed a deadline for regulations concerning drug exports.

There have been some India pharma headlines in the last week or two, so let’s do a summer roundup.

FDA Recall of India Pharma Products

The U.S. Food and Drug Administration (FDA) and the Indian government work together on pharma supply chain issues. From January 28–30, 2020, for example, a joint action called Operation Broadsword prevented approximately 500 shipments of illegal and unapproved prescription drugs and medical devices from reaching U.S. consumers.

Now, two Indian pharma companies are voluntarily recalling lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis revealed they could contain nitrosodimethylamine (NDMA), a known carcinogen, above the acceptable limit. The recall affects both 500mg and 1000mg tablets. Metformin is commonly used to treat type 2 diabetes. A complete list of all metformin products being recalled is available on the FDA website.

There are two other FDA recalls affecting Indian pharma companies. About 1,500 bottles of Clozapine are being recalled after 50mg tablets were found in bottles of 100mg tablets, and one lot of Aripiprazole tablets are being recalled because bottles labeled as containing 30 2mg tablets actually contain 100 5mg tablets. Clozapine is used to treat mood/mental disorders and Aripiprazole is used to treat schizophrenia and bipolar disorder.

India pharma company anticipates COVID-19 vaccine early next year

The chairman of Ahmedabad-based Zydus Cadila says he expects phase 1 and phase 2 studies of its novel coronavirus vaccine to be completed in three months. It is currently testing the vaccine, ZyCoV-D, for safety and efficacy. It will be compared with placebo.

As reported in the Hindu Times, Chairman Pankaj Patel said the vaccine could be ready in “about seven or a little more than seven months … provided the data is encouraging and the vaccine is proven to be effective during the trials.” He said Cadila might be able to produce up to 100 million doses a year.

Zydus Cadila is also planning to produce remdesivir, which is being used worldwide to treat COVID-19. Patel the company could produce up to 400,000 doses of the medicine in the first month after it wins regulatory approval to manufacture it in India.

India Ideas Summit 2020

The United States India Business Council (USIBC) is holding its 45th annual meeting next week. Together with the U.S. Chamber of Commerce, it will host the Ideas Summit, also an annual event, from July 21-22. It will be a virtual gathering, naturally.

This year’s theme is “Building a Better Future.” Looking to a “post-COVID world,” diplomats, scholars, senior business executives, think tanks, and other thought leaders will discuss topics ranging from geopolitics and equitable growth to the future of healthcare and digitization and technology trends.

They will also focus on global supply chains. This month, the USIBC released a white paper entitled “Positioning India to Capture Global Supply Chains & Grow Economic Opportunity.” The 22-page paper is of interest to anyone who follows supply chains and recognizes India’s position in global markets. It touches on the work of the USIBC Task Force on Supply Chain Standards and Practices and how the country is working to attract new supply chains. Read the white paper here.

Final thoughts

India will undoubtedly continue to cultivate its position in the global pharmaceutical industry. It’s actively modernizing its supply chain. For example, in April it replaced its Drugs Authentication and Verification Application (DAVA) with the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal.

We’ve worked in the India pharma market for many years and understand its complexities, challenges, and benefits. Our signature rfxcel Traceability System (rTS) and rfxcel Compliance Management (rCM) solution have helped our customers keep up with India’s regulations and remain competitive.

Contact us today to see how we can maximize your impact in India.

rfxcel Named Russia CRPT Software and Integration Partner for Nine Industries

Reno, Nevada, July 21, 2020 — rfxcel, the global leader in digital supply chain traceability solutions, today announced that it had once again been named an official software and integration partner with Russia’s Center for Research in Perspective Technologies (CRPT), which operates the country’s National Track and Trace Digital System (Chestny ZNAK). It was named an official integration, software, and tested solution partner for medications in April.

The company earned official partner status for nine industries: footwear, tires, light industry, perfumes, dairy, bottled drinking water, bicycles, wheelchairs, and tobacco. rfxcel is now an official partner for 10 of the 11 industries for which the CRPT has chosen partners.

Furthermore, at the time of this release, rfxcel was the only software and integration partner for five industries: footwear, tires, light industry, wheelchairs, and bicycles. In the remaining industries — perfume, dairy, and bottled water — rfxcel is either the sole partner a category or one of only two or three.

The new designations solidify rfxcel’s status as the leader in Chestny ZNAK. rfxcel CEO Glenn Abood said the continued success with the CRPT and Chestny ZNAK demonstrated that the company’s strategy for the Russian market was working. “We have always been the leader in supply chain compliance,” he said, “and we committed ourselves to extending that legacy to Russia. We’ve been there right from the start, growing our team in Moscow and honing our solutions to meet the strict compliance requirements. Our official partner designations in 10 industries shows we’re leading in Russia.”

Victoria Kozlova, rfxcel’s general director of Russian operations, said the new partner designations could be attributed to three things. “It’s the quality of our solutions, the support we’re getting from across rfxcel, and the quality of our team in Moscow,” she said. “We’re one of only a very few solutions providers with active implementations in Russia. That says a lot about what we’ve accomplished over the last two years. We’re also working to parlay this success with our strategies in the Commonwealth of Independent States.”

Enacted by Federal Law No. 425-FZ on December 29, 2017, Chestny ZNAK was designed to protect consumers by keeping fake and substandard products out of the market. As envisioned, by 2024 it will transform the Russian supply chain and affect virtually every industry, from pharmaceuticals to baby food. The CRPT, a public-private partnership, has managed Chestny ZNAK since 2018.

To learn more about rfxcel’s operations in Russia and its solutions for pharma, consumer goods, food and beverage, and government, contact Vice President of Marketing and Strategic Initiatives Herb Wong at hwong@rfxcel.com and visit rfxcel.com.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies manage every aspect of their supply chains, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as traceability, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the EU, Britain, Latin America, Russia, the Middle East, India, Japan, and the Asia-Pacific region.

rfxcel Continues Winning Streak in Russian Serialization, Track and Trace

Once again, Russia’s Center for Research in Perspective Technologies (CRPT) has named rfxcel an official partner, this time for software and integration for dairy, bottled water, footwear, wheelchairs, tires, perfumes, bicycles, and light industry. We’re pretty excited about this. We had already been named an official software, integration, and tested solutions partner for medications. Our team in Moscow has worked hard to make us the leader in Russian serialization and track and trace for all industries; you should contact them if you have any questions about doing business in Russia.

The CRPT is a public-private partnership that manages Russia’s National Track and Trace Digital System, known as Chestny ZNAK. Our rfxcel Traceability System (rTS) works seamlessly with the system, including a Russian-language user interface that makes integration and startup much quicker.

Let’s take a quick look at what’s going on with the dairy and bottled water industries in Russia, and why we’re leading in Russian serialization and track and trace.

The CRPT and Russian Serialization/ChestnyZNAK “Experiments”

The CRPT follows best practices by conducting “experiments” — what we would call pilots — for products before the officially enter the ChestnyZNAK system. The pilot for dairy ran from July 15, 2019, to February 29, 2020; for bottled water, the pilot began April 1, 2030, and is scheduled to end March 1, 2021.

A pilot for bicycles wrapped at the end of May 2020, and a current one for wheelchairs is  expected to end June 1, 2021. Pilots for children’s goods (e.g., baby food, clothing, toys, and games) and medical devices will apparently be announced soon.

Requirements for Dairy and Bottled Water

Russia’s supply chain regulations are notoriously strict. This is one reason being named an official CRPT partner is a feather in our cap: We’ve demonstrated that our solutions, particularly our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the requirements and ensure companies stay compliant.

We’re currently working on some other materials about the regulations for dairy and bottled water (and tires and other products), so check back soon to see those. In the meantime, however, here’s some basic information to tide you over.


All products must be labeled with a DataMatrix code. The code must contain the following:

  • The goods code (14 numerical digits)
  • An individual serial number (13 digits) generated by the CRPT or a company’s economic agent
  • A verification key provided by the CRPT (4 digits)

According to the language in the regulations, companies may include an expiration date (6 characters for non-perishables, 10 for perishables), but that is not mandatory.

Product packaging mush have a 15×15 mm space for the codes. If a product has a cap, such milk in a PET bottle, the material and surface texture must be able to accommodate printing (e.g., ink or laser).

Bottled water

The regulations recognize six categories of bottled water. In addition to three unexplained “other” categories, these include:

  • Waters, including natural or artificial mineral, carbonated, free from sugar or other sweetening or flavoring substances. (The regulations also mention “ice and snow” under this category.)
  • Mineral and carbonated waters, including natural mineral waters:
  • Non-carbonated waters

The DataMatrix code must contain the same information as the codes for dairy. And like dairy, companies have the option to include other information, such as an expiration date or a minimum retail price.

Final thoughts

Our success with the CRPT is due to a lot of hard work and our commitment to designing the best solutions for Russian serialization, track and trace, aggregation, and compliance.

When Chestny ZNAK was enacted into law on December 29, 2017, we began honing our operations in Russia. About this time last year, we reported that we had doubled the size of our team in Russia; since then, it’s tripled in size. We’re one of very few supply chain solution providers with active implementations in Russia, and we’re working with more and more companies as our reputation grows.

Our continued success with the CRPT, ChestnyZNAK, and Russian serialization boils down to the quality of our solutions and the knowledge and skill of our people, who have expertise in key areas of supply chain management and technology. They all speak Russian, of course, and they know the regulations inside and out. They understand how to meet our customers’ needs while ensuring they’re fully compliant with Russian serialization, aggregation, and supply chain compliance requirements.

Contact us today learn more about how rfxcel can help you with Russian serialization and the ChestnyZNAK regulations. And be sure to ask about our other track and trace and compliance solutions. Sure, we’re the leader in Russian serialization, aggregation, track and trace, and supply chain compliance solutions, but we can optimize any supply chain anywhere in the world. Ask us how!

What Is Pharma Supply Chain Aggregation?

We all want to know that the medicines we buy at our pharmacy are what they say they are. This is one of the main reasons why these products are strictly tracked and monitored, including serialization and pharma supply chain aggregation. From the very first step of production, all ingredients are tracked as a medicine moves down the manufacturing chain. This means every bottle of pills that is in your medicine cabinet can be traced back to the date and time of manufacture. You can even find out who was mixing the ingredients.

This is the level of tracking many countries require by law in the pharma supply chain, and many governments have imposed strict serialization regulations over the last few years. These laws are designed to combat  counterfeits and ensure consumer safety.

Serialization has many facets, including the use of Global Trade Item Numbers (GTINs), 2D barcodes, and aggregation processes. Aggregation is a crucial component of serialization in the pharma supply chain. It helps track products from the moment they’re packaged to the time they reach consumers. Aggregation contributes to the safety and efficiency of the global pharmaceutical industry.

As more and more countries update their aggregation requirements, it’s vital to understand what this process is. Let’s take a closer look at aggregation, including how it’s defined, how it works, and the different types.

What is pharma supply chain aggregation?

Pharmaceutical products have different packaging levels, and they all need to be serialized and traced. The basic levels include the unit or single case, bundle pack, case, and pallet. Aggregation creates and maintains a so-called parent-child relationship among the packaging levels and the product owner’s information. Each data aggregate is saved in a database before a product moves to the next participant in the supply chain. Here is the basic mapping of aggregation:

  • Unit-level pack aggregations (lowest level) → bundle pack aggregation → case aggregation → pallet aggregation (highest level).

How does pharma supply chain aggregation work?

Aggregation is achieved by associating serial numbers with the different packaging levels. It also entails scanning barcodes to associate/link supply chain participants with one another.

Aggregation begins with unit-level serialization, by which serial numbers are applied to the container of medicine, such as a bottle or a blister pack. This packaging is then associated with the case its shipped in, which is also given a unique serial number. When the cases are packed on a pallet, that gets its own serial number to associate it with the cases. The parent-child relationship is complete.

Why is aggregation necessary in supply chain management?

Aggregation is a necessary to make the pharm supply chain safe and secure. It facilitates traceability and transparency, and enables efficient returns management. It also eliminates the need to scan individual units. And because it makes the pharma supply chain flow more smoothly, warehouses and storage facilities save time and money. For example, with a single scan of a  barcode, workers can decommission damaged pallets, and companies can process recalls and returns more quickly and accurately.

Final thoughts

rfxcel was founded 17 years ago because our CEO, Glenn Abood, realized that consumers didn’t have a way to verify the authenticity of the medicines they buy. Today, as the longest-tenured supply chain solutions provider in the pharma industry, we offer cutting-edge technology that makes serialization, including the aggregation process, automatic, accurate, and secure. Couple this with our industry-leading compliance solutions, and you will ensure your supply chain runs at peak performance, protects your products, and secures your brand reputation. Contact us today to learn more!

Saudi Pharma Compliance: New Aggregation Deadline & More

Things have been relatively quiet with Saudi pharma compliance. The country’s Food and Drug Authority (SFDA) established the Drug Track and Trace System (RSD) to track all human registered drugs that are manufactured in Saudi Arabia or imported. Regulations that took effect in January 2019 have changed how the Saudi drug supply chain operates.

The RDS is a standardized identification system that tracks drugs from the manufacturer to the patient. It adopts GS1 standards and applies to all pharmaceutical products on the Saudi market, including over-the-counter (OTC) medicines. According to GS1, the SFDA is working on similar requirements for medical devices and cosmetics.

The SFDA’s goal is to create a safer and more efficient pharmaceutical supply chain. To succeed in the Saudi market, companies that produce, distribute, and dispense pharmaceuticals must fully understand and comply with the regulations. Let’s take a look at what’s been happening.

New Aggregation Deadline

Aggregation has been a sticking point in the Saudi pharma compliance requirements, with many delays for enactment. Here’s a quick timeline:

  • July 2019: The SFDA published guidelines for barcodes that included details for packaging hierarchies. This included barcoding, serialization, and pallet-level aggregation.
  • August 2019: The SFDA published a reminder about an upcoming October aggregation deadline.
  • December 2019: The SFDA moved the aggregation deadline to March 31, 2020.
  • April 2020: The SFDA moved the aggregation deadline to June 30, 2020.
  • June 28, 2020: The SFDA once again moved the aggregation deadline, this time till August 20, 2020.

So, as of today, companies have a little more than a month to comply with the aggregation requirements. This means they’ll have to prepare their packaging lines, coordinate with their trading partners, and have systems that can capture and report data to the RSD.

Overview of Saudi Pharma Compliance

Here’s quick rundown of what’s required for Saudi pharma compliance.

Data Matrix barcodes

Saudi regulations stipulate that all drugs must be marked with a GS1 Data Matrix barcode that contains, at minimum, a 14-digit Global Trade Identification Number (GTIN-14), a serial number, the expiry date, and the batch/lot number. This information must also be printed on labels. All transactions for drug packages must be reported to the RSD, and all manufacturers licensed by the SFDA must acquire a Global Location Number (GLN).

Saudi Drug Code

Every registered drug in the Saudi market is assigned a Saudi Drug Code (SDC) that contains four variables: a fixed prefix, the year, a letter to identify the type of drug, and a serial number (e.g., SFDA12D001). The SDC will eventually replace the current code.

Global Location Numbers

From March 2018, companies had to register the locations of their factories and warehouses using their Global Location Numbers (GLNs).

RSD Stakeholder Management and Operation Portals

Companies use the Stakeholder Management Portal for initial registration in the RSD. The Stakeholder Operation Portal is where companies and their stakeholders report movements of drugs inside the supply chain. This ensures that information about all shipments are reported to Saudi  authorities.

According to the SFDA website, after a company has integrated its system with the RSD, all drug movements will be recorded automatically; companies/stakeholders won’t have to log in to the Stakeholder Operation Portal manually or register transactions manually.

Final thoughts

Saudi pharma compliance is complex. Manufacturers, warehouses, and pharmacies have a lot to think about. Though the date for implementing aggregation requirements has changed a few times, you should assume the August 20 deadline will hold firm.

The time to start preparing is now. rfxcel can help you be ready for all Saudi pharma compliance requirements. Our signature rfxcel Traceability Platform (rTS) can help you keep track of all the products in your supply chain and ensure you’re complying with all SFDA requirements — or regulations in any country.

Contact us for more information. Our supply chain experts are ready to help!