India needs to focus on reducing dependency on single sources by qualifying other geographies
There are several challenges in the traceability of the pharma supply chain. They mainly consist of controllable factors such as managing shipment time, lead time, temperature excursions, and maintaining quality checks, and uncontrollable factors such as the Red Sea Crisis increased lead time and planning. Companies and the industry need to work towards enhancing end-to-end traceability by improving forecast accuracy and ensuring adherence to compliance. Efforts must be taken to reduce lag/lead time, avoid temperature excursions, and ensure that all related documentation is completed and filled correctly. India Pharma inc needs to focus on reducing dependency on imports and dependency on single sources by qualifying other geographies. In order to ensure quality control, supplier qualifications must include quality testing (Nitrosamine + other tests from national/government labs of the country).
Available solutions:
- Track and trace mechanisms to be installed and monitored with validation in place
- Datalogger real-time online tracking/monitoring
- Temperature challenge: Pharma companies focus mainly on cold chain and ensure that the products are transported across the length and breadth of the country using cold chain transportation. In India, we are seeing a boom of reefer vehicles which are being used across industries.
- Depute ‘speciality couriers’ rather than the regular freight forwarders. Speciality couriers have a very tight TAT and monitoring mechanism from end to end. A few companies to name, PDP, Ontime Globe, Alisped etc
- Companies have moved from traditional USB data loggers to smart IOT-based loggers which give real-time monitoring of temperature during the transit of the products and storage in warehouses.
- Counterfeits: Ensuring product artworks are changed/ reviewed at regular intervals to prevent counterfeiting. Various security measures like watermarks/QR codes etc are being used in product artworks.
A few cases from the industry
Good companies have very strong practices in transportation and logistics which aim to minimise hazards. For e.g. The drivers are enrolled on training programmes and are tested frequently to avoid any mishaps. The trucks are fitted with realtime GPS/anti-sleep alarms to prevent accidents and ensure timely delivery of products.
Though there are regulations in place, gaps exist which lead to counterfeiting
Pharma supply chains face several challenges in track-and-trace systems, which are essential for ensuring safety, preventing counterfeiting, and improving transparency. Though there are regulations in place in different countries, gaps exist which lead to counterfeiting.
- Interoperability: Different stakeholders viz. Manufacturers, distributors, chemists, and consumers use varying systems, leading to data silos and inconsistent records. 2. Global standards: Different countries have unique regulations (e.g., DSCSA in the US, FMD in Europe), complicating international distribution networks.
- Real-time tracking: Maintaining continuous, accurate tracking across complex supply chains remains difficult.
- Serialisation: Ensuring unique identifiers are correctly assigned, printed, and recorded across the chain is challenging. Many times, issues like duplicate code, and missing codes have been flagged by regulators.
- Cold chain monitoring: Tracking temperature-sensitive products, like biologics, across the supply chain is complex and costly.
- Counterfeit prevention: Despite technological advances, counterfeiters continue to bypass systems.
- Data security: Managing vast amounts of sensitive data raises concerns about privacy and cybersecurity.
- Scalability: High implementation costs, integration with legacy systems and enterprise solutions hinder widespread adoption.
- Stakeholder compliance: Coordinating across fragmented stakeholders to ensure compliance is difficult.
- Final authentication: Authenticating products at the patient level is still not fully realised.
Data-driven traceability solutions provide critical insights for compliance with global regulatory standards
The pharma supply chain faces persistent challenges related to traceability, which affects safety, efficiency, and compliance. Key challenges include counterfeit drugs, product recalls, regulatory compliance, and transparency. Counterfeit drugs pose significant risks to patient safety, and the lack of real-time visibility across supply chain partners limits response times to issues like recalls. Additionally, adhering to evolving global regulatory requirements remains complex and costly for pharma companies.
To address these challenges, effective traceability strategies are essential. At OPTEL, we leverage advanced traceability technologies to secure the pharma supply chain and meet these challenges head-on. Our solutions include end-to-end serialisation and aggregation, enabling full transparency from the raw materials stage through to the end consumer. This level of visibility helps to quickly identify and remove counterfeit products from circulation, ensuring patient safety. Additionally, OPTEL’s data-driven traceability solutions provide critical insights for compliance with global regulatory standards, simplifying adherence and reducing the risk of non-compliance.
Another key strategy is integrating advanced technologies like blockchain and AI to improve data accuracy and automate compliance. These technologies enable secure data sharing across supply chain partners, enhancing transparency and fostering trust. By implementing OPTEL’s solutions, pharma companies can protect patients, ensure regulatory compliance, and streamline supply chain operations, creating a more secure, efficient, and resilient pharma supply chain.
End-to-end traceability improves supply chain visibility and data-sharing access
The Indian pharma industry has come a long way in the last decade. We have raised our standards of storage, handling and transportation but we still have a long way to go when we compare ourselves with global standards. Spurious/counterfeited drugs are one of the reasons authorities force companies to opt for serialisation, but it comes with its challenges. Some of those are as listed:
- Track-and-trace data reliability
- Manual operations increase errors, delays, and costs
- The huge amount of interconnected data
- A fragmented picture
- Turning data into valuable insights and predictions
- Transparent, security-first data sharing
End-to-end traceability improves supply chain visibility and data-sharing access. Manufacturers can access actionable insights to develop effective strategies to optimise their resources and tackle existing supply chain inefficiencies that free up net working capital. Companies must implement serialisation (assigning unique identifiers to products) and track-and-trace systems to ensure that products are genuine and traceable throughout the supply chain.