Dolo, Saridon among 300 drugs to have QR codes from Aug 1

The Drugs Control General of India (DCGI) has directed pharmaceutical companies to ensure that there are bar codes or quick response (QR) codes on the packaging of the top 300 medicine brands like Dolo, Shelcal, Allegra, Becosules, and Saridon, among others.

Batches of these drugs manufactured on or after August 1, 2023 will need to have QR codes printed on the packaging.

The top drug regulator of the country has taken this step to curtail the sale of spurious drugs and to make sure of effective traceability. The DGCI has warned pharma companies that stiff penalties would be imposed if they did not adhere to the new regulation.

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The unique product identification code should carry the proper and generic name of the drug; brand name; name and address of the manufacturer; batch number; date of manufacturing; date of expiry; and manufacturing license number.

“Any batch of brands of the drug formulations as specified in the notification which has been manufactured on or after 1 August 2023, irrespective of the location of the manufacturing site, shall have the Barcode or QR code on its label as per the said government notification. It is mandatory to print /affix QR Code on the 300 brands of the drug formulations. However, if any manufacturer voluntarily wants to affix /print Bar code or QR Code for any other brand, he is free to do so,” said the communication from the Central Drugs Standard Control Organization (CDSCO) to pharma companies.

“It is applicable for all the indigenous as well as foreign manufacturers who are manufacturing these brands of drug formulations for marketing in the country,” it said.

The DGCI said that products should be preferably imported with affixed or printed bar code/ QR code on the label.

“However, Barcode or QR code may be affixed on the label in the country after obtaining the permission from the Licensing Authority as required under the Drugs Rules, 1945,” said the communication.

Sources in the industry said that there might be an increase of about 5-7 per cent in the cost of these drugs due to the additional printing expense.

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A representative from the Indian Pharmaceutical Alliance said that most of the 300 shortlisted drugs were manufactured by large companies, and they have been prepared for this new regulation.

The union health ministry in March 2022 had asked the Department of Pharmaceuticals to shortlist the 300 medicine brands that would have to implement the mandatory QR codes. The ministry had then issued a draft notification in June 2022, and a formal notification in November 2022.

(With inputs from agencies)