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The Union health ministry has mandated compulsory quick response (QR) code on the packaging of 300 lifesaving drugs, including Allegra, Augmentin, Shelcal, Azythral, Calpol, Dolo, Fabiflu, Meftal Spas, Montair and Pan D.

The plan will be implemented in phases from May 2023. In the first phase, top brands which hold market shares of at least 35% each for lifesaving drugs will be required to display the QR code. This is aimed at preventing the sale of spurious drugs.

In a gazette notification on Thursday, the government sought comments within 30 days from the drug industry, consumers’ associations, Indian Drug Manufacturers’ Association (IDMA) and medical professionals directly and indirectly linked with medicines.

“At present, QR code is not mandatory. Some companies are putting it on a voluntary basis. The QR code will authenticate whether a drug is an original or a spurious one, and will carry details about the company, manufacturer, date of expiry, and brand details, among others. In the first phase, the government has targeted around 300 lifesaving drugs having a 35% of total market value from major pharma brands. There is a major risk of spurious drugs being made," an official aware of the matter said, requesting anonymity.

According to the notification seen by Mint, manufacturers of products specified in Schedule H2 should print or affix bar code or QR code on its primary packaging label storing data or information legible with software application to facilitate authentication. In case of inadequate space in primary package label, it should be on the secondary package label.

“The stored data or information shall include the following particulars, namely: — (i) unique product identification code, (ii) proper and generic name of the drug, (iii) brand name, (iv) name and address of the manufacturer, (v) batch number, (vi) date of manufacturing, (vii) date of expiry, manufacturing licence number," said the notification.

In the absence of regulation, there is lack of uniformity in the QR codes voluntarily used by some pharma brands. When Mint scanned some of the QR codes, it opened the web link of the company, while some showed a PDF with information about the drug.

Industry executives said the ministry’s step will help maintain medicine quality and improve patient health and safety.

“We welcome the government’s move to introduce QR codes in medicine packaging as they can greatly help in controlling the counterfeiting of drugs by tracking their journey from factory to patient. Counterfeit drugs are a threat to patient safety and this initiative will be another important move towards assuring authenticity and traceability of the drugs," said Alok Malik, group vice-president and head, India formulations, Glenmark Pharmaceuticals.

“With this change, it will be easy to identify genuine medicines from the counterfeit ones since the QR code will contain many details like the manufacturer and batch number, expiry etc. The issue of counterfeit medicines or forge selling is one that worries companies immensely. QR codes will significantly help curb this. It is a much-needed move and will help in driving and maintaining the quality of the medicines thereby acutely focusing on patient health and safety," said Sanjeev Jain, co-founder and director of Akums Pharmaceuticals.

The move will help drugmakers source and get good quality active pharmaceutical ingredients (APIs), and ultimately increase the quality of medicines in India and hence patient health, Jain added.

The Centre had initiated this proposal in 2018; however, the health ministry took four years to introduce the legislation.

Queries emailed to the health ministry remained unanswered.

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