The task force recommended this particular solution for track and trace is based on its viability and affordability for implementing across the Indian pharmaceutical market. It also suggested the technology be implemented in several phases.

Nathan Sigworth, CEO of PharmaSecure, the largest provider of this type of SMS mobile authentication technology in India, said, “The Union Health Ministry Task Force’s recommendation of unique ID codes and mobile authentication is a great step in the fight against counterfeit medicines. The technology allows companies to protect their brands and for consumers to ensure that the medicine consumers are taking are real, not counterfeit.”

The task force recommendation is now in the hands of the Indian government who will make a decision on whether or not to require this track and trace technology as an addendum to the Drug and Cosmetics Act.

In 2011, India’s Directorate General of Foreign Trade put in place a requirement that all Indian pharmaceutical manufacturers print unique barcodes on primary medicine packages by January 2013. Sigworth said, “There has already been great interest in PharmaSecure’s technology. Over the last three years we have worked with leading companies in India to roll out our SMS authentication service on over 100 million drug packages for the domestic market.”

PharmaSecure is a software and technology company working to improve global public health using mobile phone technology. Its mission is to help pharmaceutical companies protect their drugs against counterfeiters and to connect consumers with safe medicines and enhanced healthcare. Founded in 2007, PharmaSecure is a growing company offering services in the United States, Europe, India, Africa and Southeast Asia.

“Moving Beyond the Avastin Incident”

On Thursday, March 15, the Partnership for Safe Medicines, along with Congressman Brian Bilbray and Senator Michael Bennet, organized a panel discussion to explore the growing impact counterfeit drugs are having in the United States. With the recent discovery of counterfeit version of Avastin in the States, finding a solution to this growing issue was the briefing’s main focus.

Speakers included Senator Michael Bennet, Connie T. Jung, U.S Food and Drug Administration’s Center for Evaluation and Research, Shay Reid, Pharmaceutical Distribution Security Alliance, and Joel White, Partnership of Safe Medicines.

In his opening remarks, Senator Bennet addressed the current state of the counterfeit drug issue in the U.S. and called for a uniformed drug distribution system that won’t increase costs for any part of the supply chain but will protect public health.

“We need to do more to improve the security and safety of our drug supply and distribution system,” Bennet said. “We need to know who handles our medicines from the manufacturers to the pharmacies, hospitals, wholesalers and ultimately the patient.”

As was the case in the recent fake Avastin scare, most counterfeit drugs that reach Americans are bought through online pharmacies. According to a screening done by the National Association of Boards of Pharmacy, 96% of online pharmacies acquired medicines from questionable sources, opening the window for counterfeiters that authorities hope to close.

At the moment, the FDA is looking into different technologies to help track pharmaceuticals to ensure drug safety and has developed its own vision and goals for introducing a robust track-and-trace system to the United States.

“We believe that they are out there, they are being used in other industries to track other products,” Jung said. “We also know that there are several members of the supply chain that are participating or plan to participate in pilots to see if this would work.”

The system would ideally prevent counterfeit drugs from harming Americans, facilitate the identification of prescription drugs, increase transparency within the supply chain and improve the efficiency of recalls. The FDA’s model system would use a serialization mechanism that would give each pharmaceutical package a unique number that cannot be duplicated. This would facilitate the authentication process, and document the product’s history as it moves through the supply chain.

It is clear from this briefing and other recent activities focused on counterfeit drugs in the US that there will be greater attention to the problem and its solutions in the coming year.

On Friday, 16 March, PharmaSecure was visited by one of our board members, Arun Gore of Gray Ghost Ventures, an impact investment fund. The visit synced perfectly with PharmaSecure’s weekly Savory Seminar of the week.

What’s a Savory Seminar, you ask?  It’s a program PharmaSecure has launched that involves the entire team viewing and then discussing a presentation on a useful topic over lunch every Friday.  So far, presentations have varied from an overview of anti-counterfeiting measures used in the Pharma industry today by industry expert Mark Davison, author of Pharmaceutical Anti-Counterfeiting, to recap of a recent business trip to Nigeria and the lessons learned there, to something as simple as an intriguing TED talk.  The talks have been a bit hit with team members, if not only for the free food!

Arun talked about social venture capital, and how in starting his fund at Gray Ghost Ventures (GGV) in 2003, Gray Ghost became one of the first venture funds of its kind — an impact investment fund focused on the double bottom line of profitability and social impact. When asked why such funds didn’t exist earlier, Arun referenced a number of taboos in the venture industry; the word “social” tends to imply a short-term, grants-based model versus a long-term, financially viable model. This, coupled with the recent growing pains of the microfinance sector and accusations of profiteering off of low-income communities has caused misperceptions. However, he believes that through dedicated, hands on support by investors impact investment can achieve both social and financial outcomes.

His concluding comment to the PharmaSecure team, “Keep your focus.” Young companies have conundrum of staying focused on the core goal at hand. The unique offering of PharmaSecure to provide authentic and validated medicine through SMS technology to the end consumer in India is tremendously valuable.

Last month, authorities discovered counterfeit Avastin in the U.S. market—some nineteen clinics across the country had purchased the fake drugs from an online retailer based in Canada. While many in the U.S. were shocked by the discovery, those of us that have been working to fight counterfeiting in the developing world where fake drugs have been a life and death issue for years were not. Avastin—currently in short supply in the U.S.—fetches a large sum and is the type of vital medication that counterfeiters target to turn a profit.

The medicine was thought to have been falsified in Turkey or Egypt and then sold to clinics by the Canadian retailer based in Barbados at a cut rate. While pharmaceutical supply chains in the U.S. face certain scrutiny, more and more drugs are being produced overseas and sold through non-traditional retailers, creating more possible points of entry for fakes. In short, the U.S. system of protecting against counterfeit drugs is out of date. U.S authorities and pharmaceutical manufacturers should take proactive steps to combat counterfeit drugs before we face additional scares.

The U.S. can look to both India and the European Union for examples of legislation meant to stop counterfeit drug production. Both have begun the process of mandating track-and-trace systems and within one year all pharmaceuticals produced in India will have unique, traceable ID codes marked on them. The timeline for similar regulations in the EU is a few years. On Tuesday March 6, Senate took a first step in the right direction by passing the Counterfeit Drug Penalty Act, which will increase punishments for drug counterfeiters. In order to catch counterfeiters, though, resources will need to reach the FDA to rout out these criminals. Track-and-trace legislation like that imposed in India and Europe will also help bring a standardized system for protecting drug supplies.

Before government action comes into play, though, pharmaceutical companies can protect their own brands and their consumers by serialization of their products. Since 2010, PharmaSecure has worked with Indian pharmaceutical companies to print traceable ID codes on their products—ID codes that customers can use to ensure their medicines are real and that the pharmaceutical manufacturers can use to better inform demand. By the 2013 we will have printed more than 1.5 billion packages with our codes. Alok Ghosh, President, Technical Operations, Lupin Ltd., recently told Forbes.com that quality and authentic products cannot be an exception; they are simply expected in today’s increasingly demanding marketplace. “Lupin has always put quality first and focused on making sure the right drugs reach consumers,” said Ghosh. “This is why we were one of the first pharmaceutical companies to adopt and implement PharmaSecure’s mobile authentication solutions. . . . Our consumers can confirm authenticity of any medicine in less than a minute,” adds Ghosh. “This has gone a long way in elevating the level of confidence they have in Lupin as a pharmaceutical market leader.”

Two groups in the US have jumpstarted the conversation about counterfeit pharmaceuticals: the Institute of Medicine is preparing a report on counterfeit drugs and hosted its first meeting in Washington, DC, with a distinguished panel of experts; and the Partnership for Safe Medicines will hold a briefing on the issue. The problem of fake drugs is no longer just in developing countries, it is a worldwide issue.

PharmaSecure’s track and trace authentication system provides a unique ID code on product packaging, which can be used to track every stage of the drug’s journey through the supply chain right into the hands of the end customer.

Fears over vials of fake drugs reaching stricken cancer patients are renewing scrutiny of the US pharmaceutical supply chain and raising concerns that shortages and the high cost of medicines are giving counterfeiters new opportunities.

Access the full article here.

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Consumers in India can now take proactive measures in testing the authenticity of the medicines they buy–over the counter or otherwise–with a simple SMS through PharmaSecure’s Unique ID Mobile Verification (UIMV).

This comes after a mandate issued by the Directorate General of Foreign Trade (DGFT) earlier this year. The DGFT has made it mandatory for medicines that are exported from India to have barcodes entailing unique product identification code, unique serial number, batch number and expiry date from July 1, 2011. The deadline on the mandate has been extended to July 2012.

Thanks to the mandate—and PharmaSecure–consumers can now instantly validate drugs by texting the 9 digit alpha-numeric code printed on the packs to the number provided alongside (for example: SMS gejr887zd to +91 99010.99010 for drug authenticity).

Once an inquiry is received, PharmaSecure sends an SMS back to the consumer on behalf of the original drug manufacturer, with information about the authentication of the drug, expiry dates and manufacturing details, within a few seconds. The information that a customer receives can be customized by drug manufacturers.

“SMS is a low cost, direct to end-users, and fast option. Mobiles in India are effective as people from rural India, tier two and tier three cities are fairly comfortable using it,” says Nakul Pasricha, director of operations & head- IT, PharmaSecure Product Authentication Services, India.

The PharmaSecure system is currently capable of handling 50 authentication requests per second, that is, more than four million requests per day. The systems are scalable to roll out and handle more than a trillion codes.

Mayur Danait, CIO of Lupin, which is one of the first companies to use PharmaSecure, says installing PharmaSecure for printing barcodes isn’t a Herculean task. All that manufacturers need to do is install PharmaSecure’s software–which is compatible with most of the leading printers in India–and a scanner at the end of the assembly line.

Here’s how it works: The manufacturing company purchases inactive bar codes from PharmaSecure. PharmaSecure’s software components interact with the printing software and printers on the production unit and print the codes on the drug packs. A scanner on the assembly line scans the barcodes that have already been printed on the packs of drugs.

The list of barcodes already printed is then sent to PharmaSecure which activates these codes and maintains a secure code database with a particular barcode and related details (name of the drug, authentication and date of expiry).

When an inquiry is sent to PharmaSecure regarding a specific barcode, the system churns out the required information and sends it back as an SMS.

But what if the unique code has already been used? “These UIMV codes are unique for each package. If the code is unrecognized or has already been used, the system reverts with an invalid response,” says Pasricha.

PharmaSecure can also provide manufacturing companies customized intelligence solutions–like where the drugs are selling, who is purchasing them, how long it takes to get to the market–as well as solutions to track expired drugs.

Pharmaceutical companies can also choose targeted communications with their customers where PharmaSecure can send SMS to remind consumers to take their medicine, renew a prescription, or follow up with consumers on health outcomes.

In a bid to protect the ”Made in India” brand in the pharmaceutical space, PharmaSecure has received encouraging response from Indian drug companies for its anti-counterfeit solutions of tracking and tracing medicines ahead of the government deadline of July 1, 2011, PharmaSecure Director Kishore Kar told PTI here.

As per the notification issued by the Directorate General of Foreign Trade (DGFT), all exports of pharmaceutical products from India have to comply with these anti-counterfeit measures from the said date.

India, the third largest drug production globally by volume and 14th by value, has increasingly witnessed spurious and counterfeit drugs made in China for African Countries, under the brand name of Indian drug companies. The USD 20 billion (Rs 90,000 crore) Indian pharmaceutical industry constitutes 40% exports.

Companies like Lupin, Unichem Laboratories and MSN Laboratories have already implemented PharmaSecure’s solutions for some of their products, which enables the patient to ensure authenticity of the drug by sending an SMS.

PharmaSecure is offering complete Track and Trace solution to Indian manufacturers for their export products.

“This is the most effective tool to empower consumers; it is equivalent to creating an army of enforcement agents, who would participate in this drive against counterfeiting. Currently, we are rolling out this service for over 100 million packages in India,” Kar said.

Tags: PharmaSecure PAS India, pharma, DGFT

BY FASTCOMPANY STAFF

For coming up with cost-effective protection against counterfeit drugs, which are especially prevalent in developing nations. Each individual drug package is stamped with a unique code and phone number. Consumers submit the code via text message, and PharmaSecure confirms the drug’s authenticity. The service launched last year and is currently being used in India, where the government has moved to mandate the technology. Under the law, PharmaSecure expects to produce up to a billion security codes drug drugs this year.