Drug manufacturers hail draft Rule mandating QR code on packaging of top 300 brands of drugs

Mumbai, June 24, 2022:

Drug manufacturers have hailed the draft Rule released by the Central government making Quick Response (QR) codes mandatory on the packaging of 300 life-saving drugs from May 1, 2023, saying that it will help trace source and affirm authenticity of drugs while also improving patient health and safety.

The Union health and family welfare ministry on June 16, 2022 issued a draft Rule introducing amendments to the Drugs Rules, 1945, to implement this. This is done to prevent the sale of counterfeit drugs. The information which must be stored include a unique product identification code; the proper and generic name of the drug; the brand name; the name and address of the manufacturer; the batch number; the date of manufacturing; the date of expiry; and the manufacturing licence number.
 
Appreciating the health ministry’s initiative, Raheel Shah, director, BDR Pharma Pvt Ltd said “In the lack of regulation, there is a lack of uniformity in the QR codes that some pharmaceutical brands voluntarily use. At the moment, QR codes are not required. Some businesses are doing it voluntarily. The QR code will verify whether a drug is genuine or counterfeit, and will include information such as the company, manufacturer, expiry date, and brand name, among other things. This ministry's action will aid in the preservation of medicine quality while also improving patient health and safety.”
 
“The purpose of QR codes is not only done to identify misbranded or counterfeit pharmaceutical products but also to recall products if there is a quality issue with the product that is manufactured. There are currently systems in place for recalling products based on the manual tracing of products that are distributed throughout the country. It may start from manufacturing premises to the CNF agents to wholesalers to distributors to retailers, to users. Currently, this tracking back is done manually and it is a very difficult task. This particular complexity is greatly simplified by using QR code scanning,” stated Shah.
 
“Since 100 per cent completion of the recall process is not guaranteed as of now, QR codes make the recall process more reliable and safer.  However, QR codes can also help with recollection. The recall is a crucial step in the pharmaceutical industry since it requires that each individual injection be called back if a product is produced, sold, and then discovered to have a quality issue that could harm patients. As a result, it would be difficult to tell all of the customers in a large country like India where distribution is widespread. In such cases QR codes help the most in understanding which vial has gone to which location," he added.
 
Echoing his view, Nikkhil K Masurkar, executive director, Entod Pharmaceuticals said “Pharmaceutical companies strive hard to maintain the authenticity of medicines and make sure undetected items are eradicated in the manufacturing of medicines. Drug counterfeit has recently emerged as a global threat. QR codes for drug safety can go a very long way in managing drug counterfeit and proper administration of medicines to patients. Medicine packages that now come with QR codes offer transparency about the manufacturing process, contents of the drugs and expiry date. A QR code can allow easier access to information on the prescribed medicine by the patient. The patient doesn’t need to solely rely on the information physically printed on the packaging of the medicine. Also, the information about the medicine can be easily shared to others if required. The information stored through a QR code is much more dynamic and engaging, and can also be easily amended remotely if required legally. QR codes can even allow for better data monitoring by a pharmaceutical company. QR codes for medicine administration can inform the healthcare providers about the correct dosage, timing of the medicine, and procedure thereby, saving time and error.”
 
“It is certainly a welcome move by the government which will soon make QR code mandatory on the pack of 300 medicines. The medicine packs that come with a unique QR code, will help trace the source and affirm the authenticity of products. In future we may see all the information stored on a QR code and only minimal information on the actual packaging of pharmaceutical medicines, drugs and other products,” added Masurkar. PharmaBiz