The Government of India announced on November 18 that under the new Drugs Rules or the Drugs (Eighth Amendment) Rules, 2022, mentioning a QR code or bar code on the packaging label will be mandatory for the top 300 drug formulations, including Calpol, Allegra, Betadine ointment, Gelusil, and Dolo 650. These QR codes will help verify if the drugs are fake.
The new rules will come into force on August 1, 2023, a notification issued by the Ministry of Health and Family Welfare stated.
The notification added: “The manufacturers of drug formulation products as specified in Schedule H2 shall print or affix Bar Code or Quick Response Code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with a software application to facilitate authentication.”
The QR code will have to store data of the unique product identification code, proper and generic name of the drug, brand name, name and address of the manufacturer, batch number and date of manufacturing and expiry, and manufacturing licence number.
The move aimed at curbing the sale of spurious, counterfeit or substandard drugs is already in place in several nations such as Russia, Britain, Germany, and the United States, among others.
The Indian Drug Manufacturers Association (IDMA) had earlier pointed out to the health ministry how “the data of the codes or Unique Identification Numbers in a batch are sent to the importer who loads the codes in the repository maintained by the government of that country. These governments have software to identify if there is any duplication of the UIN”.
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