In an exclusive ‘Chat with BioVoice News’, Mr Mandar Athalekar gave insights into the latest trends as well as their relevance in the context of bioscience industry. Read the detailed interview below:
What kinds of new smart technologies are being introduced to keep the supply chains updated with the fast changing environments in the bioscience sector?
Innovation and technology are both powerful growth enablers of the healthcare industry, whether biotech or biopharma, as well as agriculture industry. Therefore, the high dynamics that entail innovation and the process disruptions that entail new technologies pose big challenges to this sector. That is why this industry is now building ‘smart supply chains’ by integrating their supply chain processes across all levels with key new technologies as the Internet of Things (IoT), the Cloud and Mobile Devices and Services, Smartphones and sensors, Big Data Analytics, Optimization tools and new business models.
Application of wide range of smart technologies like Energy-saving forklifts or industrial trucks, Complex conveyor systems, RFID (Radio-frequency identification), Drones for faster delivery, Content-aware and context-sensitive information systems, Instrumented platforms for remote diagnostics, Big Data tools that process information from a huge number of inputs, Network devices connecting plants, warehouses and trucks tracking inventory and delivery status, Cloud services for vendor-to-vendor communication, Shipment tracking devices and other Supply chain analytics provide efficiencies and cost reduction opportunities, as well as means for long-term profitable revenue.
How are the perishable agriculture products taken care of, especially when being taken to thousand miles away from the source? How challenging is the global logistic supply chain?
Perishable agricultural produce, mainly fruits and vegetables, is likely to be subjected to natural decay, spoilage or destruction, whether processed or unprocessed. There are several other such products of horticulture, apiculture, livestock, marine produce, forest produce, etc. There is little disagreement that the problem of their storage and distribution has fallen short of receiving the attention they deserve. The complexity of the problem increases with related issues such as cold chain, temperature control, lack of information, technology and infrastructure, multi-agency multi-functional fragmented supply chain, quality and safety.
The supply chain management of perishable food produce consists of various processes from production in farms to delivery to the distribution outlets or end consumers. These processes involve storage and transport through a chain of intermediaries like farmers, local traders, transporters, freight forwarders, regulatory and port authorities, warehouse operators, processors, retailers, etc. and their various functions, such as transfer of ownership of commodities, movement of perishable cargo, maintenance and preservation of quantity and quality, payment to the seller and delivery to the buyer. It is mainly by streamlining these functions that movement of perishable agriculture products is taken care of globally. Few of the important measures are setting up a system of multi-functional nodal agencies to facilitate these functions, setting up a single-point payment system for all taxes, duties and other charges related to the movement of these products, either domestic or international and faster single-window clearances to prevent delays leading to decay and loss.
“Vaccines face a tougher safety standard than biosimilars due to their likely toxic effects, especially on children and people with immune deficiency. Therefore, regulatory authorities have become increasingly vigilant launching effective surveillance efforts and pre-licensing trails to monitor the safety of vaccines.”
The regulatory scenarios differ in various aspects across the world. How do the biopharma products such as vaccines and biosimilar drugs pass the compliance measures in a new environment?
Biosimilars are biotech drugs that are made to have quality, safety, and efficacy comparable to the original product. Biotech processes and products are complex. Therefore, the biggest challenges regulatory agencies across the world face are about being able to establish the correlations between the clinical safety and efficacy of a biotech product and its product quality in comparison to the original drug which is about striking the balance between financial benefits and public safety of having that drug in the market for consumer use.
Different regions may vary in the operating analytical methodology to establish this efficacy and safety, but by and large they agree on the need to have a compliance framework and procedural guidelines in this regard. For instance, the European regulatory authorities already have The “Guideline on Similar Biological Medicinal Products” and World Health Organization (WHO) is also in the process of issuing guidelines that provide globally acceptable principles for licensing biotherapeutic products similar to original licensed ones. Similarly, in the US, the FDA Policy on Coordinated Framework for Regulation of Biotechnology governs review and approval of new protein products. These guidelines recommend that a Safety Specification, Pharmacovigilance Plan and Critical Process Parameters (CPP) be submitted at the time of license application that outlines the design and performance of these products for them to pass through compliance.
Vaccines face a tougher safety standard than biosimilars due to their likely toxic effects, especially on children and people with immune deficiency. Therefore, regulatory authorities have become increasingly vigilant launching effective surveillance efforts and pre-licensing trails to monitor the safety of vaccines. The World Health Organization (WHO) is working with 12 countries, including Iran, Tunisia, Vietnam and India, to develop methods and tools for vaccine-safety monitoring and reporting them to a global database.
What are the common issues faced by the healthcare companies while moving their products through supply chain and customs? How do companies deal with these?
Healthcare is supposed to be a highly regulated sector for most obvious reasons of safety and wellbeing of the entire population. The pharmaceutical and healthcare industry world over is influenced by patent laws, safety policies, drug regulation, price regulation, insurance, illegal and corrupt practices, etc. Hence, regulatory mechanism plays a crucial role. While there are similarities between countries (like the universal need for shipment documentation, including commercial invoice, import declaration and Bill of Lading, there are local, specific requirements that have to be addressed. In India, for instance, the drug manufacturers and exporters not only need to adhere to the standards imposed by the Drug Controller General of India (DCGI) but also standards set by the Drug Regulators of the countries to which the product is being exported. Similar is the situation for most other countries as well.
Some of major supply chain issues faced by healthcare companies, particularly in customs clearance, are about having to deal with the complex procedures which also keep changing time and again. Right from product classification to extensive documentation that includes but is not limited to test certificates, clinical trial reports, licenses, etc. to valuation assessment to inspection to operational requirements like packing, shipment consolidation, containerization, capacity management, warehouse storage and handling, everything affects efficiency of supply chain.
Healthcare companies have, therefore, laid emphasis on putting in place strong operational processes and robust information systems to execute them. Some of the major benefits include timely clearances including those from drug regulatory authorities, shipment planning and optimization, risk control, shipment execution monitoring and cost control.
Which are the important trends being witnessed in the supply chain management globally? Is India updated on these or yet to catch up with the rest of the nations?
As more and more economies open up and newer markets keep emerging, making the world a truly ‘connected’ global market, so to say, Supply Chain Management is evolving into a strategic function more than ever before. It orients all its processes towards addressing the demands of markets diverse in demographics. Therefore, Competitive Sourcing, Distribution Network Planning, Operational Modeling, Complexity and Risk Management, Resource and Infrastructure Optimization, Process Automation and Control, Logistics Partnerships, Product Standardization and Innovation, Digital Technology and Information Management Systems are proving to be some of the key enablers for organizations giving them competitive edge in supply chain execution. As far as Process Technology Collaboration is concerned, Augmented Reality, Artificial Intelligence and Social Media are opening up the road to future. The number of companies making huge investments into these areas is quite rapidly rising.
India, despite being the fastest growing economy in the world, has a lot to do yet in terms of improving its supply chain management. Lack of adequate infrastructure is the biggest challenge for India. Price-sensitive fragmented market is another. Add to this a complex tax structure which subjects products to double taxation, by central government and then by respective state governments. However, all these challenges are already recognized by the government and major reforms like massive investment in development of highways, rail and container ports, new green field ports and national waterworks, GST (Goods and Services Tax) Bill and simplification of regulatory procedures to facilitate global trade are already on their way to creating an environment conducive to growth. These reforms are accelerators for India not only to catch up but surpass the rest of the nations, including the developed ones.
How does Thomson Reuters help the corporations to streamline their logistics system? How has been the experience while working with the Indian companies?
Streamlining not just logistics but the entire supply chain is the most challenging and also rewarding part of achieving sustainable business growth. Thomson Reuters has a set of cloud enterprise software solutions called ONESOURCE Global Trade solutions which help companies streamline their supply chain processes mainly through content, workflow automation and compliance. The solution has strong capabilities for managing movement of goods including import, export, product classification, customs compliance, licensing, tracking and utilizing the various trade benefits and incentives, integration with trading partners and regulatory authorities, restricted party screening, free trade agreements, visibility, document management and dashboard analytics. The solution has already been successful across almost all sectors due to its global and local regional specific capabilities which enable both domestic and multi-national companies across various sectors to configure it to their requirements.
In India, the experience has been very encouraging. After having launched our solution in India last year, we have already implemented it for a customer who is now growing into a large account relationship with us expanding footprints of our solutions. Additionally, we have been discussing with customers across all industry sectors and some of the leading pharmaceutical and healthcare companies are quite recognizably evaluating our value proposition and benefits.