Analyzing India’s Drug Export Restrictions and the iVEDA Portal

Posted on April 7, 2020July 11, 2023 by rfxadmin

In recent weeks, India has made major changes to its exporting policies, launched its new iVEDA portal, and postponed pharmaceutical regulations. The timing — in the midst of the COVID-19 pandemic and a 21-day lockdown of the country’s 1.3 billion people — raised eyebrows in both industry and government circles. Let’s take a look at what’s been happening.

Restrictions on the export of active pharmaceutical ingredients (APIs) and medicines

India is the world’s primary source of generic drugs, so its announcement last month that it was restricting the export of 13 APIs and 13 associated medicines was unwelcome news in many quarters. Indian drug manufacturers must get government permission to ship any of these APIs or medicines overseas, including:

- Paracetamol (a.k.a. acetaminophen), which is used in Tylenol
- Acyclovir, an antiviral used to treat shingles
- Antibiotics, including neomycin, clindamycin salts (i.e., hydrochloride), tinidazole, metronidazole, and chloramphenicol
- Progesterone, a hormone supplement found in birth control pills
- Vitamins, including B-12

India manufactures at least 20 percent of the world’s generic drugs; the restricted items account for about 10 percent of the country’s pharma exports. According to the FDA, in 2018, 24 percent of medicines and 31 percent of medicine ingredients imported into the United States came from India. The U.S. and Indian governments are currently holding discussions to ease the restrictions.

There has been pushback from India’s pharma sector. For example, it’s been reported that the Pharmaceuticals Export Promotion Council of India (Pharmexcil) wrote India’s Directorate General of Foreign Trade (DGFT) to protest that the restrictions will cause Indian drug companies to lose money and could harm their “credibility and reputation in the international market.”

Generic drug manufacturers in India had talked of shortages if COVID-19 continued in China, the source of many APIs for the Indian market. The Indian government has said the restrictions would be temporary. We will continue monitoring this supply chain story and provide updates when needed. Check back often.

The new national iVEDA portal for drug authentication and track and trace

On April 1, India officially replaced its Drugs Authentication and Verification Application (DAVA) with the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA). The iVEDA portal is a repository database that will be used for archiving serialized batch data; it’s key objective is not to track and trace India’s drug supply.

Manufacturers and exporters had complained of technical snafus with DAVA, including problems uploading data encoded on the 2D barcodes required on secondary and tertiary drug packaging and maintaining the parent-child relationship of these packaging levels. In response, the Department of Commerce convened a committee to consult with supply chain stakeholders, ultimately deciding to scrap DAVA and create an entirely portal for validation and authentication of drugs for export.

The iVEDA portal was developed by the Centre for Development of Advanced Computing (C-DAC), “the premier R&D organization of the Ministry of Electronics and Information Technology for carrying out R&D in IT, electronics, and associated areas.” Pharmexcil held testing workshops in Mumbai, Ahmedabad, Hyderabad, and Chandigarh on February 10, February 11, March 3, March 5, respectively, to give stakeholders an opportunity to use the portal and give feedback.

Big change to a regulatory deadline

Just before iVEDA launched, India’s Directorate General of Foreign Trade announced a deadline change for the implementation of the track and trace system for drug exports, particularly as it applies to the parent-child relationship of drug packaging.

On March 31, Public Notice No. 66/2015-2020 extended the date for compliance from April 1, 2020, to October 1, ,2020:

The date for implementation of track and trace system for export of drug formulations with respect to maintaining the parent-child relationship in packaging levels and its uploading on central portal has been extended up to October 1 this year.

The extension makes sense given the problems manufacturers and exporters had maintaining the parent-child relationship of secondary and tertiary drug packaging in DAVA and the newness of iVEDA.

The change applies to both small-scale industry (SSI) drugs and non-SSI drugs. Manufacturers and exporters must still print 2D barcodes for different packaging levels (i.e., primary, secondary, and tertiary) and upload the data to iVEDA, but they do not have to maintain the parent-child relationship between secondary and tertiary packaging until October 1. These stakeholders must also have a manufacturer code and product code allotted by GS1 India, though codes from C-DAC will apparently suffice. They are also responsible for the correctness and completeness of data and ensuring its timely upload to iVEDA, but according to some reports may shift this burden to an adjacent supply chain trading partner, such as a wholesaler, distributor, or retailer.

Final thoughts

rfxcel has worked in the Indian pharma market for many years. We 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. And keep an eye on our blog for more information about how COVID-19 is affecting global supply chains. Stay safe!

rfxcel Joins the COVID-19 Healthcare Coalition

Posted on April 7, 2020December 2, 2020 by rfxadmin

Washington, D.C., April 6, 2020. rfxcel, the global leader in digital supply chain traceability solutions, today announced that it has joined the COVID-19 Healthcare Coalition, a collaborative private-industry response to novel coronavirus that brings together leading organizations in healthcare, technology, academia, the nonprofit sector, and government.

The coalition’s goal is to save lives through data analytics. Gathering real-time data is key to learning about COVID-19 and how to best deliver healthcare to protect public health.

The coalition operates according to five guiding principles:

- All members participate for the benefit of the country only. No organization will be given preferential advantage.
- All members cooperate and openly share their plans.
- Members will not be paid for working with the coalition. Each member brings its own resources; no money is exchanged.
- Verbal agreements will suffice to get the coalition’s work started.
- If an organization agrees to these terms and conditions, it can join the coalition.

rfxcel has been developing industry-leading track and trace software since 2003, longer than any company serving the life sciences and the business of government. Keeping with the coalition’s wish for members to bring their unique assets to support industry stakeholders, front-line responders, and federal, state, and local government organizations in the COVID-19 pandemic, the company is offering two of its cutting-edge supply chain solutions, rfxcel Integrated Monitoring (rIM) and Accurate Immunization Management (AIM), as part of its contribution to the COVID-19 Healthcare Coalition.

rfxcel Integrated Monitoring (rIM)

rIM uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. It is widely used in pharmaceutical cold chains to monitor high-value medical supplies, including vaccines. rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, such as temperature, humidity, light, orientation (tilt), and shock. It also monitors location, so it can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements. It can monitor at both the top level (e.g., case, pallet, truck) and the item level (e.g., syringe, packet, bottle), yielding true supply chain traceability and transparency.

Accurate Immunization Management (AIM)

AIM is an automated, cloud-based solution that tracks the dispensing of vaccines — including potential vaccines for COVID-19 — in the supply chain and seamlessly integrates with critical healthcare applications such as Electronic Health Records (EHRs) and Immunization Information Systems (IIS). It empowers healthcare practitioners to view patients’ immunization records in real time, manage accurate administering, monitor inventory, and safely dispense the right vaccines to the right patient at the right time. AIM utilizes Centers for Disease Control and Prevention (CDC) rules and guidance for vaccine combinations, special populations, and required intervals between vaccines, and adheres to U.S. Food and Drug Administration (FDA) rules for dispensing. Because it is automated, users can be up and running with virtually no training, ensuring quick implementation in mission-critical locations.

Greg Moulthrop, vice president of rfxcel’s Worldwide Government Group, and his Washington, D.C.-based team of government and supply chain experts are leading the company’s efforts to bring rIM and AIM to the coalition’s fight against COVID-19. rfxcel will support the Supply Chain Working Group, facilitated by MITRE Corporation, to bring its technology to coalition members. Working across government and in partnership with industry, MITRE and its public-private partnerships and federally funded R&D centers tackle challenges to the safety, stability, and well-being of the country.

“We are proud to be a member of the COVID-19 Healthcare Coalition and donate our time and resources to addressing this public health crisis,” Moulthrop said. “rfxcel’s Worldwide Government Group is focused on mission readiness and develops tools to protect the supply chain against disruptions for the most vulnerable products. We care about protecting the public; in this case, we must protect the health and well-being of people across the country — across the world — against COVID-19, which is revealing how much we rely on robust, secure supply chains. With rIM and AIM, rfxcel can do its part to safeguard people and, we hope, hasten both the end of COVID-19 and the recovery of our communities and economy.”

rfxcel CEO Glenn Abood said the company was honored to join the coalition and was eager to get to work. “We had been considering how we could do more to help defeat COVID-19,” he said. “We feel that our everyday work is helping by keeping supply chains moving in the pharma, food and beverage, and consumer goods industries, but we felt we could do more. When Greg told us about the coalition, we were all in.

“rIM is an award-winning environmental monitoring solution that’s proved itself over and over in the pharma industry,” Abood continued, “so it was a logical choice to share with the coalition. And AIM, which we released late last month, was a no-brainer. We had been working on it for a while and successfully tested it with some of our major customers. We were excited about releasing it, but we couldn’t have imagined the timing would coincide with COVID-19. We hope deploying it to the coalition will make a difference.”

To learn more about rfxcel’s work with the COVID-19 Healthcare Coalition or what rfxcel offers the government, contact Greg Moulthrop, vice president of rfxcel’s Worldwide Government Group, at publicservices@rfxcel.com or visit rfxgov.com.

To learn more about rfxcel and its supply chain solutions, contact Vice President of Marketing Herb Wong at 925-824-0300 or 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.

COVID-19 and the Retail Food & Beverage Supply Chain: Industry Update

Posted on March 30, 2020July 24, 2020 by rfxadmin

March 31, 2020: Chances are your life isn’t the same as it was just two or three weeks ago. In the time of COVID-19, you might be self-quarantining. Your local government may have closed your neighborhood playgrounds and parks. Or maybe your governor has issued a stay-at-home order.

There’s also a very good chance that many of your favorite restaurants and bars are closed. In fact, all the “non-essential” or “non-life-sustaining” businesses in your community might be shut down.

One thing hasn’t changed, however: You can still go to the grocery store. You may have to wait in a line, standing on lengths of tape or spray-painted lines spaced at the proper social distance (six feet). Your store may limit how many people are allowed inside at one time. It may have set up special hours for senior citizens to shop.

But your grocery store is still open. This means the food and beverage supply chain continues to operate during the COVID-19 pandemic. Let’s take a look at a few things you should be aware of today.

1. The Basics: What is the CDC saying about grocery stores and COVID-19?

The Centers for Disease Control and Prevention (CDC) doesn’t have specific guidance for grocery stores; instead, it provides “Interim Guidance for Businesses and Employers to Plan and Respond to Coronavirus Disease 2019 (COVID-19).” It clearly states that businesses and employers can prevent and slow the spread of COVID-19.

The CDC’s key recommendations are summarized below. See the full details here, and visit the CDC website regularly to get the latest news about COVID-19 and recommendations for staying safe.

Reduce transmission among employees

- Actively encourage sick employees to stay home.
- Identify where and how workers might be exposed to COVID-19 at work.
- Separate sick employees.
- Educate employees about how they can reduce the spread of COVID-19.

Maintain healthy business operations

- Identify a workplace coordinator who will be responsible for COVID-19 issues and their impact at the workplace.
- Implement flexible sick leave and supportive policies and practices.
- Assess your essential functions and the reliance that others and the community have on your services or products.
- Determine how you will operate if absenteeism spikes (e.g., from employees getting sick or having to stay home to care for family members or to watch children).
- Establish policies and practices for social distancing.
- If you have more than one business location, give local managers the authority to take appropriate actions outlined in their COVID-19 response plan based on local conditions.

Maintain a healthy work environment

- Consider improving the engineering controls using the building ventilation system (e.g., increase ventilation rates and the percentage of outdoor air that circulates into the system).
- Support respiratory etiquette and hand hygiene for employees, customers, and worksite visitors.
- Perform routine environmental cleaning.
- Perform enhanced cleaning and disinfection after people suspected/confirmed to have COVID-19 have been in your place of business.

2. What are industry associations saying about COVID-19?

Grocery workers are being hailed as heroes and front-line fighters; they are the penultimate link the retail food supply chain, the people who literally hand products to consumers. Here is what some industry associations in the United States are saying about COVID-19.

The National Grocer’s Association provides best practices for its members. These follow the CDC guidance, but also have grocery-specific recommendations, such as:

- Assigning employees to regularly sanitize shopping carts and other high-traffic or high-touch areas
- Increasing or adding hand sanitizing stations around stores for customers and employees
- Changing store hours to encourage shopping at times with fewer people
- Scheduling specific hours of operation for vulnerable populations to shop without other customers

The Food Industry Association provides extensive resources about COVID-19. Visit its “Key Resources” page here. It also offers two excellent publications for download: Guidance for the Food Industry: Coronavirus Outbreak: I. Best Practices and Planning for the Immediate Situation (March 17, 2020) and Guidance for the Food Industry: Coronavirus Outbreak II. Short-Term Best Practices (March 26, 2020). Both offer guidance and information about the food supply chain, including:

- Evaluate receiving and delivery practices to minimize human-to-human contact. For example, limit the sharing of pens or equipment.
- Work with suppliers to identify local manufacturers and producers of essential products.
- Coordinate with buying departments or retail customers; learn about their plans to “bulk up” on core items so facilities can be secured for emergency storage.
- Increase volumes in-demand items such as pasta, sauces, canned foods, instant noodles, frozen meals/foods, cleaning detergents, alcohol, hand sanitizer, and paper products.
- Offer to collect from suppliers where stock is available; agree on basic commercial terms to cover costs.
- Accept deliveries when they’re available from suppliers and prioritize inbound bookings.
- Relax on-time performance metrics.

The American Beverage Association is one of 60 signatories to a letter advocating for a national public framework in which food, beverage, and consumer packaged goods manufacturers and their transporters are exempt from bans and curfews. It called for “uniformity and consistent policies,” noting that food, beverage, and other packaged goods manufacturing facilities have been exempted from bans and curfews in some states but not others. These groups say a uniform national policy will “ensure continuous delivery of essential services.”

Furthermore, on March 18, the association sent a letter directly to President Trump “advocating for common-sense actions to help our industry operate and deliver products during this challenging time.” These include (quoted verbatim):

- Exempting employees involved in the manufacture, distribution, delivery, and stocking of food and beverage items from federal, state, or local restrictions to ensure continuous delivery of essential services.
- Putting forth an executive action to lift truck weight limits, historically governed by state law, to facilitate meeting the critical need of delivering essential goods in response to COVID-19.
- Clarifying ambiguity surrounding the Federal Motor Carrier Safety Administration’s (FMCSA) hours of service guidance. Specifically, requesting the FMCSA clarify in writing that the restocking of grocery store shelves by delivery drivers is included in what constitutes direct assistance for supporting emergency relief efforts.

3. What is the U.S. Food and Drug Administration (FDA) saying about COVID-19 and the food supply chain?

The FDA released its latest statement concerning the food supply chain on March 28. In it, the agency said it was “working around the clock to make sure that Americans have access to safe food and medical products.” Here are the key statements concerning the food supply:

- Retail supply chains remain strong.
- The FDA is working with food manufacturers and grocery stores to identify shortages in the human and animal food supply chain. It is in contact with industry and trade associations about supply chain issues.
- There are “no widespread disruptions reported in the [human and animal food] supply chain.”
- “Empty grocery shelves” resulted from “unprecedented demand,” not shortcomings in the ability to produce, process, and deliver goods.

On March 26, the FDA released “Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry” (Docket No. FDA-2020-D-1108). It states the FDA’s “current intent … in certain circumstances related to the impact of the coronavirus outbreak (COVID-19).” It contains nonbinding recommendations, not a legal pronouncements; companies “can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.”

The document address regulations in three areas

1. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
3. Foreign Supplier Verification Programs for Importers of Food for Humans and Animals

Final Thoughts

The situation is changing every hour, every day. Like all responsible companies, rfxcel is monitoring the spread and affects of COVID-19. Foremost in our minds is the well-being of our employees and their families and our customers and their employees and families.

As for the F&B supply chain, we have powerful solutions to help keep things moving. The latest version of our signature rfxcel Traceability System (rTS) is the most complete and flexible raw materials and finished goods traceability solution for F&B. And our rfxcel MobileTraceability app can track any batch, movement, and handler at any location, putting the power of a digital supply chain at your fingertips. Learn more about these and our other solutions for F&B here.

And we want our customers to know we are open and operating at full capacity. Our supply chain solutions are designed to keep working under extraordinary circumstances. If you have any questions or concerns, contact your rfxcel account and project managers.

Please keep an eye out for further updates via email and on our website, and contact us if you have any questions, We are here to help and answer your questions.

COVID-19 (Coronavirus) and the Global Supply Chain: 5 Things to Know

Posted on February 27, 2020July 27, 2020 by rfxadmin

COVID-19 has affected a wide array of industries and their supply chains. A February 7 article in Forbes reported that 421 global companies, including 394 based in the United States, had discussed the COVID-19 outbreak in China during calls about first-quarter earnings. Their conclusion? The virus could have a negative impact on financial performance for that timeframe.

rfxcel is monitoring news about COVID-19. Below, we summarize five of the most recent developments. As we all know, the situation is changing every day — as do the key takeaways about how the virus is affecting global supply chains — so these are snapshots, not analyses, predictions, or conclusions.

We’ll continue following the situation, so check back often for updates.

1. Monday, Feb. 24: Potential U.S. Supply Chain Disruptions as More COVID-19 Cases Reported in China, Japan, and South Korea

China, Japan, and South Korea are major U.S. trading partners. Combined, these countries accounted for more than 25% of total American imports in 2019. Let’s break down the numbers from the U.S. Census Bureau to get an idea of the potential impacts on U.S. supply chains if factories in these countries were shut down for long periods.

China: No. 3 in total trade value in 2019

- From 2018 to 2019, China’s trade with the United States fell 15.15 percent, from $654.36 billion to $555.25 billion.
- In 2019, exports totaled $106.63 billion and imports totaled $448.62 billion (deficit of $342 billion).
- Top 10 exports: civilian aircraft, parts; computer chips; soybeans; motor vehicles for transporting people; machinery, parts for semiconductor manufacturing; medical instruments for surgeons, dentists, vets; oil; plasma, vaccines, blood; medical equipment for physicals; medicines in individual dosage
- Top 10 imports: cell phones, related equipment; computers; toys, children’s bicycles, games; TVs, computer monitors; motor vehicle parts; furniture, parts; seats, excluding barber, dental; electric water, space, soil heaters; lamp and lighting parts; computer parts

Japan: No. 4 in total trade value in 2019

- Trade totaled $218.29 billion. Exports totaled $74.65 billion and imports totaled $143.64 billion (deficit of $68.98 billion).
- Top 10 exports: civilian aircraft, parts; petroleum gases, other gaseous hydrocarbons; medical instruments for surgeons, dentists, vets; medicines in individual dosages; corn; machinery, parts for semiconductor manufacturing; pork meat, fresh, frozen or chilled; coal, briquettes; plasma, vaccines, blood; oil
- Top 10 imports: motor vehicles for transporting people; motor vehicle parts; machinery, parts for semiconductor manufacturing; self-propelled heavy construction machinery; defense-related aircraft, parts; printers, all types, parts; value added to a returned import; medicines in individual dosages; motor vehicle engines; aircraft engines, engine parts

South Korea: No. 6 in total trade value in 2019

- Trade totaled $134.41 billion. Exports totaled $56.9 billion and imports totaled $77.51 billion (deficit of $20.61 billion).
- Top 10 exports: oil; machinery, parts for semiconductor manufacturing; computer chips; petroleum gases, other gaseous hydrocarbons; civilian aircraft, parts; motor vehicles for transporting people; frozen beef; medical instruments for surgeons, dentists, vets; gasoline, other fuels; acyclic alcohols
- Top 10 imports: motor vehicles for transporting people; motor vehicle parts; gasoline, other fuels; computer parts; cell phones, related equipment; computer chips; plasma, vaccines, blood; unrecorded media for audio; rubber tires; refrigerators, freezers

2. Monday, Feb. 24: Shanghai introduces measures to help companies resume production and mitigate impact of COVID-19 outbreak

Local authorities in Shanghai’s Pudong New Area have introduced rent reduction, rent exemption, and other policies to help companies affected by the virus. The Pudong New Area is home to the Lujiazui Finance and Trade Zone and the Shanghai Stock Exchange, as well as the Port of Shanghai, the Shanghai Pudong International Airport, and the Zhangjiang Hi-Tech Park.

The Pudong New Area State-owned Assets Supervision and Administration Commission said more than 1 billion yuan (approximately $142 million) in rent reduction and exemption would benefit about 8,000 companies in the industry, retail, commerce, and technical services sectors.

According to officials, 66 percent of industrial enterprises, 93 percent of software information service companies, and more than 85 percent of foreign trade enterprises have resumed work in this key economic area.

In the nearby Lingang Special Area of China (Shanghai) Pilot Free Trade Zone, 971 companies have resumed operation and more than 40,000 employees have returned to work. Key sectors here include integrated circuits, artificial intelligence, biomedicine, aerospace, and new energy vehicles.

3. Friday, Feb. 21: Chinese President Xi Jinping says manufacturing supply chains should get help to resume output

At the meeting of the Communist Party Politburo on February 21, the Chinese president said the country must work to both contain the spread of COVID-19 and ensure that industry can resume output and meet economic targets. These comments came as businesses question Chinese suppliers’ ability to meet demand and consider finding other places to source materials.

“Priority should be given to ensure leading companies that are important in the global supply chain restore production and supply, maintaining the stability of the supply chain,” he said to the 25-member Politburo. “It is necessary to help key export enterprises resume work and production as soon as possible.”

4. Monday, Feb. 17: China has issued 1,600+ “force majeure certificates” to protect companies from legal damages arising from the COVID-19 outbreak

The China Council for the Promotion of International Trade (CCPIT) has issued 1,615 force majeure certificates to companies in more than 30 sectors, covering a total contract value of 109.9 billion yuan (approximately $15.7 billion).

Furthermore, China’s Ministry of Commerce has instructed six trade associations in the healthcare, textile, machinery, mining and other sectors to help with legal counseling and applying for the certificates.

A certificate protects a company that does not perform or only partially performs contractual duties by proving it is being affected by circumstances that are beyond its control. The CCPIT says its certificates are recognized by governments, customs organizations, trade associations ,and enterprises in more than 200 countries and regions.

5. Tuesday, Feb. 11: Dun and Bradstreet release white paper about COVID-19’s effect on global business

Here’s what the commercial data and analytics company estimates:

- Approximately 90% of all active businesses in China are in the regions affected by COVID-19.
- At least 51,000 companies around the world have one or more direct or Tier 1 suppliers in the affected region; 163 of these are Fortune 1000 companies.
- At least 5 million companies have one or more Tier 2 suppliers in the affected region; 938 of these are Fortune 1000 companies.
- Currently, 49,000 businesses in the affected region are branches or subsidiaries of companies headquartered outside China. Nearly half of these are based in Hong Kong, 19% are in the United States, 12% in Japan, and 5% in Germany. Other countries include the United Kingdom (including the Virgin Islands), the Cayman Islands, the Netherlands, Switzerland, and France.

Tag: COVID-19