The Comptroller General of Medicines will investigate the authenticity of major brands of medicines


An initiative to verify the authenticity of ‘high value and volume’ brands of drugs is underway at the Office of the Comptroller General of Drugs of India (DCGI). It is an authentication system of 300 major brands, covering a third of the pharmaceutical market.

The effort is to allow patients to verify whether their medicine is genuine, said Dr S. Eswara Reddy of DCGI. The initiative involves sending a 14-digit code printed on the medicine strip to a telephone number. Software at the end of the business will respond and authenticate the drug, he explained, adding that a draft notification about it was likely available soon.

Simultaneously, a committee representing those involved and impacted by the initiative is also being set up to resolve procedural issues, Reddy said. Activity area. “The effort is to have a policy that is ‘enforceable and results-oriented’,” he said.

Unlike a track and trace effort in 2015 covering all drugs on the market, the current discussion is limited to the top 300 brands. “These products have a high sales value or sell in high volumes, and therefore become targets for counterfeiters,” said Reddy. With an estimated market share of 36,000 crore, he said, the first brand generates around 450 crore, while the 300th brand accounts for around 60 crore in sales.

Aligned, but careful

Representatives of pharmaceutical companies, who reflected at the end of last month with the DCGI, urged the regulator to be cautious. The industry is “aligned” with the government on verifying the authenticity of products, an industry representative said, but the system should be “thoughtful, foolproof and cost effective,” he said, not not wanting to be named. “Sometimes counterfeiters have a head start. They grab a genuine product from the market and also print the unique authentication code on the fakes. So if a customer first picks up the counterfeit and sends the unique code to the company number, the system is unable to differentiate and mistakenly authenticates a counterfeit product, he said.

There are also additional costs to the company that might have to employ a third-party technology vendor to generate the unique code and allocate resources to maintain the system, the representative said. The previous system cost 7 yen per drug strip, he said, adding that it involved logistics management in terms of managing the various manufacturing lines. .

“Printing and supporting an additional code reduced their costs. In fact, companies making drugs at controlled prices must also be allowed to increase their prices according to the additional investments they may incur, ”said the hand of the industry.

While the medical initiative may follow a Delhi High Court case on anti-counterfeiting measures for water bottles, DCGI is expected to set up a technology platform that is a comprehensive solution, a- he declared. “In addition to authenticating a drug, it should support follow-up measures in terms of registering a complaint and following up on the infringer leading to an arrest,” he added.

The DCGI retorts that the initiative did not involve a major financial investment on the part of companies. While patients would benefit from a real drug, he said, companies would also stand to gain from the initiative that deters counterfeiters.

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