QR Codes To Weed Out Spurious Medicines: All you need to know
Starting from August 1, 2023, the Union Health Ministry in India has introduced a new regulation mandating the use of quick response (QR) codes or barcodes on the packaging of 300 essential medicines listed under Schedule H, which are prescription-only drugs. Some of the commonly used medicines covered by this mandate include Allegra, Augmentin, Shelcal, Azythral, Calpol, Dolo, Fabiflu, Meftal Spas, Montair, and Pan D. This move aims to ensure the quality of medicines and enhance patient health and safety. Let”s delve deeper into this new rule.
Why Has the Government Implemented This New Rule?
The primary goal of this regulation is to establish the authenticity of pharmaceutical products. QR codes and barcodes on medication packaging will provide crucial information, including the manufacturer”s name and the expiration date, among other essential details. Although some pharmaceutical companies have voluntarily included QR codes on their packages in the past, the lack of standardised regulations has led to inconsistency. The government has initially focused on approximately 300 lifesaving drugs from major pharmaceutical brands, which represent about 35% of the total market value. This rule applies to both domestic and foreign companies that manufacture these brands for the Indian market.
What Information Must QR Codes or Barcodes Contain?
QR codes and barcodes on medicine packaging must include specific information to ensure traceability and safety. These details comprise a unique product identification code, the brand name, the generic name of the drug, the name and address of the manufacturer, the batch number, the manufacturing date, the expiration date, and the manufacturing license number. If there is insufficient space on the primary packaging label, this information should be present on the secondary packaging label.
How Will the QR Codes and Barcodes Be Applied to Imported Medications?
According to government guidelines, imported products should ideally have barcodes or QR codes affixed prior to arrival in India. However, if this is not the case, the concerned company can apply these codes within India after obtaining the necessary permissions from the licensing authority, as stipulated under the Drugs Rules of 1945.
In summary, the Indian government has mandated the use of QR codes or barcodes on the packaging of 300 essential medicines under Schedule H to ensure medication authenticity, improve traceability, and enhance patient safety. This regulation has come into effect to standardise the labeling of pharmaceutical products and promote transparency in the healthcare sector.
