Center advertises QR code on labels of top 300 drugs to ensure authenticity


The Center on Friday announced the introduction of a quick response (QR) code or barcode on the package label of top 300 drug formulations, including Calpol, Allegra, Betadine ointment, Gelusil and Dolo 650, under the New Drug Rules or Drugs (Eighth Amendment) Rules, 2022.

The new rule will come into effect on August 1, 2023, according to a notification issued by the Department of Health and Family Welfare. These QR codes will make it possible to verify the authenticity and traceability of medicines.

The Department of Health and Family Welfare issued a draft notice on the matter in June this year which stated: “Manufacturers of drug formulants specified in Schedule H2 shall print or affix a code to bars or a quick response code on the primary packaging label or, if there is insufficient space on the primary packaging label, on the secondary packaging label that stores data or information readable with a software application to facilitate authentication.”

According to the notification, the QR code will have to store the data of the unique identification code of the product, the proper and generic name of the drug, the brand name, the name and address of the manufacturer, the batch number and the date manufacturing and expiration, and manufacturing license. Number.

According to the sources, the pharmaceutical industry has requested 18 months from the date of final notification to implement the same. To implement this, the union health department made the necessary amendments to the Drug Rules of 1945.

Earlier this year, the Ministry of Health had asked the Department of Pharmaceuticals to enlist 300 drug brands for the implementation of mandatory QR codes. As instructed, the National Pharmaceutical Pricing Authority (NPPA) identified the list of 300 drugs used for blood sugar, hypertension, painkillers, contraceptives and vitamins.

The Center had said that Active Pharmaceutical Ingredients (APIs) or bulk drugs manufactured or imported in India should bear a QR code on their label at each level, a package that stores data or information readable with the software application for facilitate follow-up.

According to reports, the World Health Organization earlier estimated that around 35% of the drugs sold globally in the market came from India. Industry officials said the move was a good move to prevent fake drugs from circulating in the market. However, the implementation of the QR code can increase drug prices by 3-4%.

The new rule will come into effect on August 1, 2023, according to a notification issued by the Department of Health and Family Welfare. These QR codes will make it possible to verify the authenticity and traceability of medicines.

(Edited by : Anouchka Sharma)


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