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Centre announces QR code on labels of top 300 drugs to ensure authenticity 

Centre announces QR code on labels of top 300 drugs to ensure authenticity 

Centre announces QR code on labels of top 300 drugs to ensure authenticity 
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By Timsy Jaipuria  Nov 18, 2022 11:56:25 PM IST (Published)

The Centre on Friday announced to introduce Quick Response (QR) Code or bar code on the packaging label of the top 300 drug formulations including Calpol, Allegra, Betadine ointment, Gelusil, and Dolo 650, under the new Drugs Rules or the Drugs (Eighth Amendment) Rules, 2022.

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The new rule will be effective from August 1, 2023, as per a notification issued by the ministry of health and family welfare. These QR codes will help verify the authenticity and traceability of the drugs.
The ministry of health and family welfare in June this year issued a draft notification for the same which stated,  "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."
As per the notification, 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.
According to the sources, the pharmaceutical industry has sought a period of 18 months from the date of final notification to implement the same. To implement this, the union ministry of health made necessary amendments to the Drugs Rules, 1945.
Earlier this year, the health ministry had asked the department of pharmaceuticals to enlist 300 drug brands for the implementation of mandatory QR codes. Following the instructions, the National Pharmaceutical Pricing Authority (NPPA) identified the list of 300 drugs which are used for blood sugar, hypertension, painkillers, contraceptives and vitamins.
The Centre had said active pharmaceutical ingredients (APIs) or bulk drugs that are manufactured on imported in India shall bear a QR code on its label at each level, packaging that stores data or information readable with the software application to facilitate tracking.
According to reports, the World Health Organisation earlier estimated that around 35 percent of the drugs sold globally in the market come from India. The officials from the industry said that the step is a good move to avoid the circulation of fake drugs in the market. However, the implementation of the QR code may push the prices of the drugs up by 3-4 percent.
The new rule will be effective from August 1, 2023, as per a notification issued by the Ministry of Health and Family Welfare. These QR codes will help verify the authenticity and traceability of the drugs.
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