The mandatory QR codes on APIs
Nakul Pasricha, President, ASPA, explains how a timely step taken by the government of India can impact the supply chain to make the pharma industry robust and secure
The Indian pharma industry is one of the most prominent in the world. In recent years, the country has earned its reputation as a pharmacy due to its significant role in producing and delivering pharma products for the global healthcare ecosystem. This puts a considerable responsibility on the country to ensure that all measures are taken to ensure the excellent quality of the products. Making the use of QR codes mandatory on Active Pharmaceutical Ingredients (APIs) used in medicines is a timely step by the Government of India in the right direction. The new rule will be applicable from 1st January, 2023.
This might seem like an insignificant step or something that may be dismissed as a prerogative for the industry, but the real winner would be the end users and patients. It will facilitate the identification of authentic products, making the system more efficient by weeding out sub-standard and falsified medical products. Moreover, considering India’s increasingly important role in the global healthcare system, this step will support its endeavours in securing world health. This will reinforce the country’s commitment to medicine safety in India, and globally. This step will help distinguish spurious and original drugs and make the ecosystem vulnerable to sub-standard and falsified products. However, it would be advisable to adopt a robust and comprehensive approach.
The government has been mindful of giving pharma companies enough time to adopt the new regulatory requirement. This will give them time to plan and execute efficiently before the deadline. It is advised that the pharma companies coming under the purview of this proactively work towards adopting the new regulatory requirement.
Some might argue against it, citing that the input cost will increase. But, in reality, the task is achievable, QR codes are a practical solution readily available and easily workable at a nominal price. On the other hand, the benefits are considerable, especially with regard to the significant impact it will have in making the supply chain in the pharma industry secure. The Indian authentication industry is capable and capacitated to provide the required solutions.
Sub-standard and falsified medical products is a big problem across industries globally. The issue demands immediate attention and measures in critical areas such as pharmaceuticals. A batch of falsified drugs or vaccines can lead to a grave tragedy. Counterfeiters are becoming more intelligent, and we need to stay one step ahead of them. The loopholes exist in our systems. In many incidents, we have noted that counterfeiters fool people simply by replicating the product packaging while potentially putting inactive or even harmful contents inside the vial/packing. For instance, in Varanasi’s recent seizure, the accused allegedly filled empty vials with distilled water and passed them off as vaccines. To make the COVID-19 rapid antigen test, the accused used pregnancy strips that look like pregnancy kits as both are strip-based tests. They procured pregnancy kits from the market and pasted a wrapper of the antigen kit.
To combat the problem, the complete supply chain must be secured by implementing a combination of digital and physical measures, e.g., tamper-evident seal/closures supported with digital track-and-trace measures QR codes/barcodes. The ideal solution must include physical and digital features providing authentication and increased digital security to reduce system vulnerability. The approach adopted by the European Union (EU), falsified medicine directives, is a good example. It introduced two new safety features that must be present on each pack or bottle of medicine: a unique identifier (a 2D barcode containing a unique 20-digit pack number, as well as other data) and a physical Anti-Tampering Device (ATD). India should implement these measures on formulated drugs as well. This helps establish the product’s authenticity and tracks the product’s journey through the supply chain. Many cutting-edge solutions are available, and customised solution sets can be curated suited for the specific needs of pharma products.
Indian pharma companies adhere to strict anti-counterfeit mandates for exports of drugs. Unfortunately, the same is not followed for drugs circulated in the domestic market. The government issued the only guidelines for voluntary adoption. The new mandatory regulation is a concrete step taken by the government.