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The Indian Drug Manufacturers’ Association (IDMA) has proposed to the National Pharmaceutical Pricing Authority (NPPA) to allow 30 paisa per unit additionally in the ceiling price to offset the capital expenditure for every scheduled formulation of top 300 drugs for printing QR code.
The Central government has notified mandating QR code on the label of top 300 brands of formulations from August 1, 2023 which will help identify fake and spurious drugs. As of today, 67 companies are marketing 300 drugs. Companies marketing the top 300 brands are in the process of setting up the infrastructure to adhere to the implementation deadline.
According to the IDMA representation to the NPPA, “There is a huge capex of Rs. 86 lakh involved initially for printing QR code as there are 5 to 6 lines where these top 300 drugs are manufactured. It involves the cost of LAN, the software, the camera, the sensor, the printer plus the QR code which ultimately is a huge cost.”
“The cost of setting up the infrastructure for authentication of the top 300 drugs is huge as each camera costs Rs. 4 lakh per line, thermal inkjet printer is Rs. 4 lakh per line and 300 brands need minimum 3 to 4 lines spread across multiple locations. In addition, one-time costs of software and licenses need to be borne. Some relief should be provided at least for scheduled formulations to offset this cost as there has been an unprecedented increase in input costs,” an industry official added.
The Union ministry of health and family welfare on November 17, 2022 came out with gazette notification no 823E implementing the Drugs (Eighth Amendment) Rules, 2022, which introduced a new Schedule H2 with a list of 300 top brands, and inserted Sub-Rule (6) and (7) after the Sub-Rule (5) in the Rule 96, of the Drugs and Cosmetics (D&C) Rules, 1945. This makes it mandatory for pharmaceutical companies to affix QR code on the pack of top 300 formulations from August 1, 2023.
As per the new gazette notification, QR code will contain the unique product identification code, generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacture, expiry date and manufacturing license number.
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