Few pharma industry experts and stakeholders informed that 20 per cent of the medicines that are manufactured in India are counterfeit. The mandatory QR codes on APIs will help in checking or eliminating the sub-standard or falsified medicines.
Informing that QR Codes for drug safety can go a very long way in managing drug counterfeit and proper administration of medicines to patients, 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. 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 with 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 the 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,” he added.
Commenting about the NPPA move to shortlist the top 300 brands of drugs which will have to put QR codes on their packages, enable tracking and ensure authenticity, Sanjeev Jain, Co-founder and Director, Akums Pharma, said, “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, and QR codes will significantly help in curbing this issue. While the government has started implementing it phase-wise; the first phase being for the top 300 brands, 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.”
“Secondly, the Health Ministry-issued rule notification that will be applicable from January 1, 2023, further mandates that companies put QR codes on active pharmaceutical ingredients (APIs) manufactured or imported in India. These QR codes shall contain on their label information like APIs, name and address of the manufacturer, batch number, batch size, date of manufacturing, date of expiry or retesting, etc. This move will help medicine manufacturers to source and get good quality APIs, and ultimately increase the quality of medicines in India and hence the patient’s health,” he added.
Adding that the move will help in controlling the counterfeit of drugs, Alok Malik, Group Vice President and Head, India Formulations, Glenmark Pharmaceuticals Ltd, said, “Move to introduce QR codes in medicine packaging 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 ensuring authenticity and traceability of the drugs.”
Elucidating that such measures will substantially increase the cost for manufacturers of small and medium players, a domestic pharma manufacturer on condition of anonymity said, “The NPPA move is a welcoming one but for more branded products it would be easy to adopt such measures, not for small and medium players it will increase our cost. Our concerns also need to be addressed and proper guidelines are necessary before implementing the proposal.”
Highlighting the QR codes in medicines, Daara B Patel, Secretary-General, Indian Drug Manufacturers’ Association (IDMA), spoke about the implementation of QR codes on APIs from January 1, 2023, as per Gazette No 20(E) dated January 18, 2022. He informed that the notification stated that at present, all the existing packaging of APIs require appropriate labelling under the provisions of The Drugs and Cosmetics Act. These labels already contain most of the information specified under QR code notification.
Further, he added that the notification has not informed the operational procedure for the implementation of the scheme. In the absence of appropriate guidelines, it is not known whether such information is required to be shared or uploaded on any servers maintained by the government.
“It is stated in the notification — Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear a Quick Response code on its label at each level of packaging that stores data or information readable with a software application to facilitate tracking and tracing. Hence, it is implied that manufacturers and buyers should have software that will automatically authenticate the information in the QR code in real-time with some online database. There is no mention in the notification of who will be the vendor for providing such a solution. The onus, therefore, will be on the industry to find such a vendor to provide a complete solution of authentication/tracking and tracing. We do not understand how this is going to be uniformly decided between thousands of API manufacturers in India and abroad selling APIs in India,” Patel said.
Patel emphasises that notification on QR coding for API is not mandated in any other country, if API manufactured in India is to be exported, it must have a QR code label even if the destination country has no such requirement. He also informs that it may create additional confusion at foreign customs – this is a self-enforced trade barrier.
He informed that the QR code label is not providing any additional details that will help in improving the quality or tracing of APIs sold in India. In fact, all information to be provided in QR code can clearly be read on the current label written in English, or that label can be expanded to include additional data. We fail to see how adding QR code labels is providing any new benefit. On the contrary, we find it will simply increase compliance by making small and medium-scale manufacturers perform an additional task when creating their labels.
As the industry experts welcome and also raise concerns about the implementation of QR codes in pharma, it needs an amicable and practical solution as they roll out including costs, implementation of technology and proper guidelines by the government to counter the problem of counterfeit drugs.