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.

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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.

The unique identifier codes will be applied to several of Unichem’s leading medicines, including Trika for the treatment of anxiety and Losar for the treatment of high blood pressure and hypertension. The codes will be integrated into existing manufacturing processes at two plants in India.

This unique product security solution empowers consumers to check whether a drug is authentic via text message (SMS) using a mobile phone. When a consumer receives their medication, they are able to text the unique identifier on the individual strip to a phone number that is printed alongside the code. The consumer then receives an authentication text message from Unichem in response.

This is the only technology currently in use in the Indian market that empowers consumers themselves to check the authenticity of their medicines.

This system ensures data protection and brand security to manufacturers for branded, branded generic and generic manufacturers through seamless factory integration. It also provides customized CRM services based on its authentication platform to enhanced consumer protection and improved health outcomes.

Unichem chose PharmaSecure’s technology because of it’s high scalability and the team’s ability to integrate the system efficiently into its current factory processes. There will be no change to the Unichem’s manufacturing process and production output will remain the same.

Quotes:
“We selected PharmaSecure’s technology based on the company’s excellent customer service and ability to implement the technology across multiple products at different plants, and without disruption,” said Dr. Prakash Mody, Chairman and Managing Director of Unichem Laboratories Ltd. “Strengthening our brand and differentiating our products is an ongoing process of our business operations and it is essential that we use the latest technology like the one PharmaSecure offers to protect the interests of our customers.”

About Unichem Laboratories Limited

Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the company is a leader in niche therapy areas of cardiology, neurology, and orthopedics and anti-infectives. The company has strong skills in product development, process chemistry and manufacturing of complex API as well as dosage forms.

More information about the company can be found at www.unichemlabs.com

The news comes just weeks after PharmaSecure signed its first pharmaceutical customer for the technology after a successful pilot in India earlier this year.

The aim is to protect products and consumers from counterfeiting and diversion, according to the two companies, which said Unichem had purchased 70 million codes to apply to products distributed nationally in India in the first instance.

PharmaSecure’s alphanumeric codes can be printed directly onto the blister pack, medicine bottle or vial, or indeed onto a product’s label. The unique identifier codes can be texted by a consumer to a phone number that is printed alongside the code. Within seconds, a message is sent from Unichem back to the consumer to indicate whether or not the code is genuine.

Two of the brands that will carry the codes are Unichem’s anxiety treatment Trika (alprazolam) and Losar (losartan) for high blood pressure, although the company said that the decision to apply the technology was not a direct response to a counterfeiting problem.

"This is an additional feature that will provide more value to their customers," said a spokesman for the company.

"These are just a couple examples of drugs that Unichem may put the codes on and the first ones that have been coded so far; the project is not necessarily limited to these drugs," he continued, adding: "These were done first because they are high-volume and fast-moving products that will hit the market soon, and it allowed trials and implementation at a variety of types of packaging facilities."

Unichem said in a statement it chose PharmaSecure’s technology because of its high scalability and ability to integrate efficiently into current factory processes. The codes will be set up at two plants in India.

There will be no change to Unichem’s manufacturing processes and production output will remain the same, it added.

Publication: GUJARAT SAMACHAR

Date: 17/12/2010

Edition: MAHARASHTRA