Falsified and counterfeit drugs are a major threat to the Indian economy. This menace has been wreaking havoc for decades, affecting India’s brand equity and the well-being of citizens.
According to experts in the pharmaceutical industry and stakeholders, an estimated 20% of all drugs manufactured in India are fake. Considering that the Indian pharmaceutical industry features as a leading manufacturer worldwide, it is a great responsibility to live up to the standard and ensure exceptional quality of drugs.
In an effort to get rid of counterfeit medicines from the market, the Indian Government declared QR codes mandatory on APIs (Active Pharmaceutical Ingredients) in drugs as a well-timed step in the right direction. This new rule shall be applicable from January 1, 2023.
A Step to Combat Counterfeit Medicines
The end users or patients would be the real winners here. Mandatory QR Codes shall facilitate authentic product identification to make the system more capable of weeding out falsified and substandard medicines and drugs.
Most importantly, with India’s contribution to global healthcare rising, this step will support worldwide health endeavours. It would further reinforce the commitment to the safety of medicines in the country and around the world.
It’s noteworthy that the Indian Government is mindful of giving pharmaceutical companies adequate time to implement this new regulation. The Government suggests that pharma companies under this purview should work proactively towards the new regulation, and rightly so. As such, the pharma companies can efficiently plan operations while adhering to the deadline.
Addressing Major Challenges
Before we get into the nitty-gritty of preparations, it’s important to outline that the enforcement agencies are already facing major challenges due to the absence of anti-counterfeiting, anti-tampering, and lack of traceability measures. As a result, it is easier for counterfeits to reach end users. Moreover, deficient legal frameworks and weaker administrative measures also compound the issue. Lack of consumer and brand awareness combined with fragmented distribution channels further adds to the woes.
There may be several challenges in adopting the new regulation. Firstly, streamlining the supply chain is the biggest hurdle. Secondly, digitising the medicine products with QR codes is another test. Also, the risk of fake QR codes cannot be ignored.
ASPA’s 5-year Strategic Planning for Preparation
The President of ASPA (Authentication Solution Providers’ Association), Nakul Pasricha, confirmed that the decision to regulate QR codes for APIs shall enable quick identification of genuine products to make the system more useful and rule out all kinds of substandard medicines.
The 5-year ASPA strategic planning, from 2022 through 2027, is to make India a global voice of the pharma industry in ATS (Authentication & Traceability Solutions). This would essentially prepare pharma companies and the supply chain to develop smart ways to trace and track. Most importantly, it promotes the idea of developing innovative tools to measure the extent of counterfeits.
The Strategic Plan of ASPA (2022-2027) outlines six goals:
- Advanced research and development
- Promote adoption
- Increase awareness of ATS (Authentication & Traceability Solutions)
- Develop tools to measure the effect of counterfeit medicines and their extent
- Encourage and adopt best practices and professional ethics
- Enhance ASPA’s global footprint and reach
Steps To Prepare to Adopt QR Codes for APIs
As the deadline for API implementation is approaching, companies must prepare to adopt the regulations. Counterfeiters are smarter and more intelligent. Deploying QR codes for APIs is presently the only way to stay a step ahead.
Here’s how to prepare:
Secure Supply Chain
It is imperative to have a robust and secure supply chain to weed out counterfeiting completely. The supply chain involves a series of steps and several catalysts playing active roles in delivering the products to the right place. Securing this process with tracking systems can eliminate the risk of fake medicines entering the system.
Physical & Digital Measures
To secure an entire supply chain, it is crucial to take the necessary physical and digital measures. For instance, tamper-evident seals and closures with digital track-and-trace features like QR codes and barcodes can enhance security at multiple levels. Ideally, the solution should include digital and physical features to authenticate and increase digital security, thus, reducing system vulnerabilities.
Track Product Journey
QR codes are the safest and most secure means of tracking products through the supply chain and establishing authenticity. There are several cutting-edge technologies readily available, along with a customized set of solutions curated to suit the specific needs of the products in the line.
The Final Word
According to experts in the pharmaceutical industry, it would be difficult for small and medium-sized businesses to adhere to the changes. Making the changes in packaging is a massive challenge that involves costs and labour.
Nevertheless, Indian pharma companies agree that having one QR system would be more convenient. Presently, medicines are traced from different departments. Pharma companies should prepare to have one unique system that streamlines the process.
While the Indian pharmaceutical companies follow a strict anti-counterfeit mandate for exported drugs, the same does not apply to the domestic market. The Indian Government has taken this regulatory step as a concrete measure to eradicate counterfeits from the domestic market. It is time to act now and prepare for the change.
Connect with us to prepare a roadmap for growth as the mandate comes into effect.
