Introduction
The Indian pharmaceutical industry is growing rapidly, ranking as the 3rd largest in the world by volume and 14th in value. Indian medicines are exported to more than 200 countries worldwide, including the US, Japan, West Europe and Australia. This has earned India the title of ‘Pharmacy of the World’. To keep up with this exponential growth and ensure the Indian pharma supply chain remains robust and safe, implementing track and trace technology is paramount. In this blog you will understand what is track and trace technology, the importance of track and trace technology in the pharmaceutical sector, benefits of this technology to pharmacies and businesses, and how you can take advantage of this.
Understanding Track and Trace Technology
Track and Trace technology in the pharma sector refers to the software system which helps in managing and monitoring the movement of pharmaceutical products being supplied in the market, right from the procurement of raw materials to the end consumption. This technology empowers businesses in getting real-time information about their products and verifying the product’s supply chain path to ensure product reaches the right place at the right time.
With the pharma industry growing exponentially, it is extremely crucial to implement a pharmaceutical track and trace system. The complex nature of the pharma supply chains make them prone to disruptions and thus they require a technology that can help counter challenges. Technology is revolutionising several industries and pharma is no exception, it has become the cornerstone of a sustainable future growth of the pharma industry. Track and Trace solutions for the pharmaceutical industry is a technology that helps in early detection of counterfeit drugs, improves supply chain visibility and helps in meeting regulatory compliance.
To meet these benefits effortlessly, the Government of India (GOI) has issued several mandates. In 2023, GOI made it mandatory to have GS1 QR codes on Active Pharmaceutical Ingredients (API) used in medicines, in the same year a mandate was released for the top 300 pharma brands to have GS1 QR code on their drugs. The Indian government has also expressed the need to implement a Unique Device Identifier (UDI) for medical devices and to mandate QR codes for cancer drugs, vaccines and antibiotics to prevent counterfeit drugs from entering the market.
Here are the types of technologies that can be used or are being used for pharmaceutical track and trace –
- Barcodes – QR codes or Quick Response codes are being used in the pharmaceutical industry to implement track and trace. QR codes are a type of 2D barcodes that can contain extensive information which are used by drug manufacturers/pharmacies/ consumers. These codes contain information of the drug manufacturer, expiry and manufacturing date, batch number information and other crucial information of the drug which is helpful in differentiating original drugs from counterfeits in the market.
- RFID – Radio Frequency Identification (RFID) technology has been used in the hospital industry for a very long time to retrieve patient information and monitor locations of the patient in the hospital. This technology can be used to track and trace pharma drugs throughout the supply chain. RFID tags can be tracked and traced throughout the supply chain, making it easier for hospitals and manufacturers to ensure the drug reaches the patient on-time.
With RFID tags on medicines, hospitals and the pharma industry can answer the five most vital questions – what is in stock? How much is it? Who has it? Where to locate it? And when to reorder it? Thereby, managing the drug inventory and making the work less cumbersome and more efficient.
- Blockchain – Blockchain technology is a database of information which allows secure and easy information sharing across a network. The data in a blockchain is stored in blocks making it impossible for anyone to change or delete and only the participants of this technology can make changes in it. Its use in healthcare can prevent sale of counterfeit medicines, authenticate drugs and can help in achieving pharmaceutical track and trace.
The Need for Track and Trace in Pharmaceuticals
When it comes to healthcare, patient safety is of utmost concern and cannot be compromised. When falsified drugs and counterfeit medicines are present in the pharma supply chain, it can directly impact the patient’s health. Falsified medicines are those medicines which are fake but are made to look like real medicines. They may have the same identity but their composition and source are different from the original. Counterfeit drugs are medicines that are not supplied by the original manufacturer of the product and thus do not have the patent rights or registered trademarks. The presence of both is detrimental to the society and can negatively impact the health, trust and safety of the consumers.
Another important reason to have track and trace solutions for the pharmaceutical supply chain is to minimise and mitigate adverse drug reactions on patients. During the supply of drugs in the market, sometimes the drugs can be found of substandard quality or may contain impurities. To ensure such drugs do not reach the patients and to prevent the supply of such drugs in the medicines, track and trace solution plays a crucial role.
Benefits of Track and Trace Technologies in Pharma
The track and trace technology can be instrumental in realising various benefits in the pharmaceutical industry. Some of them are mentioned below –
- Enhanced Supply Chain Visibility – When the pharma industry has a system to track and trace the supply of drugs or medical devices, they will benefit from increased supply chain visibility. This visibility empowers the pharma manufacturers in making the right decisions at the right time.
- Inventory Management – Hospitals or manufacturers can ensure they have sufficient drug inventory with track and trace. They can avoid situations of understocking and provide right drugs to patients without fail.
- Real-time Tracking – Track and trace pharma enables tracking of pharma drugs real-time. This helps mitigate situations wherein the drug composition is compromised or counterfeit drugs are present. Manufacturers can track their drugs on a real-time basis and take necessary actions whenever and wherever required.
- Reduced Counterfeit drugs – With enhanced visibility of the pharma supply chain, manufacturers can drastically reduce the supply of counterfeit drugs in the market. With technology such as QR codes, drug information can be validated at each level thus preventing counterfeit drugs from entering the market.
- Effective Recall System – Pharmaceutical track and trace makes it possible to strengthen the drug recall system. Manufacturers can recall their drugs from the supply chain as soon as they get aware of an existing quality issue. They can carry targeted recalls of the affected drug lot and ensure only safe drugs reach the end consumers.
- Robust Patient Safety – The health and happiness of patients cannot be undermined in any case. The existence of track & trace pharma drugs ensures the patients are treated with authentic drugs and at the right time.
How You Can Implement Track and Trace technology
If you are a drug manufacturer you can reach out to GS1 India to get barcodes for your drugs or medical devices. You can follow the below listed steps in order to get registered for GS1 barcodes –
Step 1: Visit GS1 India’s ‘Register for Barcodes’ page.
Step 2: Follow the instructions on the page and click on the registration form link.
Step 3: Complete the registration form, fill in all your necessary details and provide the required documents.
Step 4: Submit the form. You will receive an allotment letter along with your Global Company Prefix (GCP) within 7-10 working days which can be used to generate barcodes.
Please note, GS1 India is the only authority in India authorised to issue barcodes to companies be it in healthcare, retail, transport or food and agriculture.
Conclusion
Implementing track and trace technology in the pharmaceutical industry is necessary to achieve robust patient safety. While the industry is still in process to implement this, its wide adoption and implementation is inevitable. The excessive availability of counterfeit drugs in the market necessitates quick adoption to such technology in order to safeguard consumers’ trust. Contact GS1 India’s team today to get registered for authorised barcodes and play your role in achieving a smarter and more efficient healthcare supply chain.
FAQs
1.What is trace and track system?
Ans. Track and trace system refers to a solution which allows businesses to monitor and track the movement of products in the market.
2. What is track and trace serialisation?
Ans. Pharma serialisation is a method of assigning unique codes or identifiers on the drugs or medical devices for their unique identification in the market. These codes facilitate track and trace of these products.
3. What is the difference between trace and track?
Ans. Tracking is the ability to know and understand the current location of a product whereas tracing refers to the backward tracking or following the journey travelled by a product in the supply chain.
