In a notification dated 18th January 2022, the Ministry of Health and Family Welfare has notified the Drugs (Amendment) Rules, 2022 to further amend the Drugs Rules, 1945. The amendment has made Quick Response (QR) codes on its label mandatory at each level of packaging on Active Pharmaceutical Ingredients (APIs) to clear the way for tracking and tracing of the products. The new rule will come into force from January 01, 2023.
As of now counterfeiting, piracy and duplicity have become global problems. They are harming the image of any business along with the reason. Allegedly, 20 percent of the medicines that are produced in India are counterfeit. According to a government report, three percent of medicines are of low quality.
The repercussion of counterfeiting in the pharma industry has affected many lives and people. However, the industry has less than a year to execute the new amendment, but pharma stalwarts and stakeholders already started throwing light on this decision. In the first place, they emphasize that this is a crucial step taken by the government that will lead to several benefits for the pharma manufacturing domain.
The Track and Trace feature of traceability on APIs is influential as it will assure the quality and safety of the end-users. By executing a Streamline working method and a healthy set of processes, manufacturers can make sure transparency throughout their supply chain.
The call for API traceability
According to the API Traceability Regulation, every active ingredient imported or manufactured in India must have a QR code on its label, and that code must be present at each level of packaging too. The presence of a QR code will allow supply chain members to read the product information just by scanning the code. Stakeholders will be able to track and trace the drug throughout the supply chain process journey in a concise manner. It will commend the identification of genuine products, making the system more coherent and well organized by deterring poor-quality and falsified medical products.
Many Organizations already have their supply chain platform before this mandate rule with their services for helping the confirmation and tracking of any product and customer satisfaction. Considering India’s more and more important role in the global healthcare system,
- This step will support its attempt in securing world health.
- This will strengthen India’s commitment to medicines safety in India and globally.
- This step will help pick out bogus and original drugs and fortify the ecosystem from poor quality and falsified products.
Eventually, the real winner from this new mandate rule would be the end users and patients.
The benefit of API traceability to the pharmaceutical industry
Serialization and traceability will authorize pharmaceutical supply chain members to keep tabs on all APIs traversing through the supply chain. This will not only help stakeholders find counterfeit products that are not genuine, but it will also enable them to make decisions on quick product recalls and investigations.
Furthermore, the web-based system will help traders and producers in consuming and supplying primary and secondary information accurately in a convenient manner, allowing for the faultless accumulation of pharmaceutical products.
Besides that, an end-to-end record system allows manufacturers, repackagers, distributors, and other supply chain members to execute systematic distribution. Plus, with all data logged in a centralized system, inventory management will never again be a struggle.
Herewith API regulation, India has distinctly taken a significant step toward establishing a sustainable supply chain. When completely deployed, the track-and-trace system will fill up all the gaps in the system, building a vigorous pharmaceutical supply chain free of any sham or low-quality products.
TRACESCI, a SaaS platform powered by Blockchain Authentication, Traceability, and Consumer Engagement is a very effective and commercially viable supply chain authentication & tracking solution.
It provides brand owners, deep consumers, and supply chain insights regarding their products like real-time GPS location, scanning patterns, and suspicious activity alerts. It will help to get actionable data for strategic decision-making and operational excellence.
It can be adapted on a free trial and can be upgraded to the next levels based on requirements, both IOS and Android mobile applications are available for effective live tracking, authentication, and supply chain management.