Few experts and stakeholders in the pharmaceutical industry have indicated that 20% of drugs manufactured in India are counterfeit. Mandatory QR codes on APIs will help verify or weed out substandard or falsified medicines.
Informing that QR codes for drug safety can greatly contribute to the management of counterfeit drugs and the proper administration of drugs to patients, Nikkhil K Masurkar, Executive Director of ENTOD Pharmaceuticals, said: “Pharmaceutical companies strive to maintain drug authenticity and manufacture sure that undetected items are eradicated in drug manufacturing. Drug counterfeiting has recently emerged as a global threat. Medicine packaging that now comes with QR codes provides transparency on the manufacturing process, medicine content and expiry date. A QR code can facilitate access to information about the medication prescribed by the patient. The patient does not need to rely solely on the information physically printed on the drug package. Additionally, drug information can be easily shared with others, if needed. information stored via a QR code is much more dynamic and engaging, and can also be easily changed remotely if required by law. the codes may even enable better tracking of data by a pharmaceutical company. QR codes for drug administration can inform healthcare providers about the correct dosage, timing of drug administration, and procedure, saving time and errors. »
“It is certainly a welcome move by the government who will soon make the QR code mandatory on the 300 medicine pack. Medicine packs that come with a unique QR code, will help trace the source and affirm the authenticity of the products. In the future, we can see all the information stored on a QR code and only minimal information on the actual packaging of pharmaceutical drugs, drugs and other products,” he added.
Commenting on the NPPA’s decision to shortlist the top 300 drug brands that will be required to put QR codes on their packaging, enable tracking and ensure authenticity, Sanjeev Jain, co-founder and director of Akums Pharma, said: “With this change, it will be easy to identify genuine drugs from counterfeit drugs as the QR code will contain many details such as manufacturer and batch number, expiration date, etc. Although the government has started to implement it in phases; With the first phase being for the top 300 brands, this is a much-needed step that will help drive and maintain the quality of medicines, which, acutely by focusing on patient health and safety.”
“Secondly, the rule notification issued by the Ministry of Health which will be applicable from January 1, 2023, further obliges companies to affix QR codes on Active Pharmaceutical Ingredients (APIs) manufactured or imported in India. These codes QRs should contain on their label information such as API, manufacturer’s name and address, batch number, batch size, date of manufacture, date of expiration or new test, etc. This decision will help drug manufacturers to s ‘sourcing and obtaining good quality APIs, and ultimately increasing the quality of medicines in India and hence the health of the patient,’ he added.
Adding that this decision will help to control counterfeit medicines, Alok Malik, Group Vice President and Head of Indian Formulations, Glenmark Pharmaceuticals Ltd, said: “The decision to introduce QR codes in medicine packaging can greatly help control counterfeit medicines by following their journey from the factory to the patient. Counterfeit medicines are a threat to patient safety and this initiative will be another important step towards ensuring the authenticity and traceability of medicines.
Noting that such measures will significantly increase the cost for small and medium-sized manufacturers, a national pharmaceutical manufacturer on condition of anonymity said: “The NPPA’s decision is welcome, but for more branded products, it would be easy to adopt such measures, not for small and medium-sized players, it will increase our costs. Our concerns must also be taken into account and proper guidelines are needed before implementing the proposal.
Highlighting QR Codes in Medicines, Daara B Patel, Secretary General, Indian Drug Manufacturers Association (IDMA), spoke about the implementation of QR Codes on APIs from 1 January 2023 as per the Gazette No. 20(E) of January 18. , 2022. He informed that the notification stated that currently all existing API packaging requires proper labeling under the provisions of the Medicines and Cosmetics Act. These labels already contain most of the information specified in the QR code notification.
Further, he added that the notification did not inform the operational procedure for the implementation of the scheme. In the absence of proper guidelines, it is unclear whether this information should be shared or uploaded to government-run servers.
“It is stated in the notification – Every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported into India must carry a rapid response code on its label at each level of packaging which stores data or information readable with a software application to facilitate tracking and Therefore, it is implied that manufacturers and buyers must have software that will automatically authenticate the information contained in the QR code in real time with an online database. mention in the notification of who the vendor will be to provide such a solution, so it will be up to the industry to find such a vendor to provide a full authentication/track and trace solution, we don’t understand how this is going to be decided evenly among thousands of API manufacturers in India and abroad selling APIs in India,” Patel said.
Patel points out that notification on QR coding for API is not mandatory in any other country, if API made in India is to be exported then it must have QR code label even if destination country has no no such requirement. He also advises that this may create additional confusion at foreign customs – this is a self-enforced trade barrier.
He informed that the QR code label did not provide any additional details that would help improve the quality or tracing of APIs sold in India. In fact, all the information to be provided in the QR code can be clearly read on the current label written in English, or this label can be extended to include additional data. We don’t see how adding QR code labels provides any new benefit. On the contrary, we find that it will simply increase compliance by requiring small and medium manufacturers to perform an additional task when creating their labels.
While industry experts also welcome and raise concerns about the implementation of QR codes in the pharmaceutical industry, an amicable and practical solution is needed as they are rolled out, including costs, the implementation of technology and appropriate government directives to counter the problem of counterfeit medicines.