Drugs Controller General to study genuineness of top medicine brands

An initiative to check the authenticity of “high value and volume” medicine brands is under process at the office of the Drugs Controller General of India (DCGI) . It involves an authentication system for 300 top brands, addressing one-third of the pharmaceutical market.

The effort is to enable patients to check if their medicine is genuine, said DCGI Dr S Eswara Reddy. The initiative involves sending a 14-digit-code printed on the medicine strip to a phone number. A software at the company’s end will respond and authenticate the medicine, he explained, adding that a draft notification on this was likely soon.

Simultaneously, a committee representing those involved and impacted by the initiative is also being set up to work out procedural issues, Reddy told BusinessLine . “The effort is to have a policy that is “implementable and result oriented,” he said.

Unlike a “track and trace” effort in 2015 covering all medicines in the market, the current discussion is limited to the top 300 brands. “These products either have a high sales value or sell in large volumes, and as a result become targets for counterfeiters,” Reddy said. With an estimated market share of ₹36,000 crore, he said, the top brand grosses about ₹450 crore while the 300th brand is about ₹60 crore in sales.

Aligned, but cautious

Drug company representatives who brainstormed late last month with the DCGI, urged the regulator to tread with caution. The industry is “aligned” with the government on checking the authenticity of products, said an industry representative, but the system should be “thought through, foolproof and cost-effective,” he said, unwilling to be named. “Sometimes counterfeiters are a step ahead. They pick-up a genuine product from the market and print the unique authentication code on the counterfeits as well. So, if a customer picks up the counterfeit first and messages the unique code to the company’s number, the system is not able to differentiate, and erroneously authenticates a counterfeit product, he said.

There is also additional cost to the company that may have to employ a third-party technology provider to generate the unique code and allocate resources to maintain the system, the representative said. The earlier system worked out to ₹7 per medicine strip, he said, adding that it involved logistics management in terms of handling different manufacturing lines. .

“Printing and supporting an additional code ate into their costs. In fact, companies making price-controlled drugs also need to be allowed to hike their price in line with the additional investments they may incur,” the industry hand said.

Though the medicine initiative may be a follow through from a Delhi High Court case on anti-counterfeit measures for water bottles, the DCGI should put in place a technology platform that is a comprehensive solution, he said. “Besides authenticating a drug, it should support follow-up measures in terms of registering a complaint and tracking the counterfeiter leading to arrest,” he added.

The DCGI counters that the initiative did not involve a major financial investment from companies. While patients would benefit from a genuine medicine, he said, companies also stood to gain from the initiative that would deter counterfeiters.

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