By Dinesh Pilgaokar
Despite being one of the most highly regulated industries, the pharmaceutical industry faces great challenges across drug counterfeiting, impacting patient safety. Poor visibility, supply chain inefficiencies, limited transparency across distribution, and inaccurate demand forecasting compound the challenge today. The aim and objective to counter these challenges should be to build a digitally transparent and traceable pharmaceutical supply chain from the primary vendor to the end customer.
Pharmaceutical manufacturing must follow very strict SOPs and guidelines by autonomous expert authorities or governments to maintain an audit trail and track record of all transactions. In practice, if a pharmaceutical drug's origin has to be traced, it has to be tracked back through the distribution system to the plant and the vendor who supplied the raw material.
In the ideal state – pharmaceutical companies should be able to go granular to a level of tracing the day, shift, operator, machine, equipment, and raw material used for a batch, and the constituents of the batch could be traced to the vendors.
Digital transformation is critical for the pharmaceutical industry to achieve greater agility, patient safety, and affordable access to citizens. The government has also emphasised the role of digital technology in making India a key player in global supply chains. Adopting these technologies will increase efficiency, quality, and compliance adherence, ultimately strengthening India's position as the pharmacy of the world. Further, adopting technology can ensure compliance and trust among all stakeholders, including private and public stakeholders and patients.
Adopting technology to aid digitisation across the industry can lead to higher visibility and transparency, eliminate any manual intervention for any transactions, and subsequently maintain higher data integrity, a factor critical to help analyse deviations and provide insights to any manufacturer or governing authority.
Digital transformations in the pharmaceutical manufacturing
The generation, collection, and analysis of electronic data across the end-to-end pharmaceutical supply chain will be crucial to enable these digital transformations.
Data captured at different stages, beginning with the vendor or supplier with a record of all transactions across the various stages and processes throughout the supply chain, will enhance digital transparency and integrity. This is the missing link today and can be improved via operational technologies.
From effectively managing the vendor ecosystem, driving increased asset and workforce efficiency and quality within manufacturing, accurate demand forecasting, and shortening delivery cycles, operational technologies have an important role. The value proposition can be powerful with the ultimate objective of patient safety.
The government has made significant progress in mandating new technology, such as barcodes, on the top 300 manufactured medicines to begin with. This is a big step towards empowering the customer. Further use of applicable hardware and software technology is needed to create a digital record of every pharmaceutical drug produced.
This digital record should contain information about the raw materials used, the parameters under which the drug was manufactured, and electronic signatures against every supply chain step. Additionally, technology can help ensure standard operating procedures are followed, deviations are captured, and manual interventions are eliminated during manufacturing. These technologies will empower manufacturers to take proactive corrective measures and external and government auditors to ensure compliance adherence and verify authenticity.
Conclusion
Embracing and adopting digital transformations will help the private sector increase efficiency, quality, demand forecasting, and production planning, leading to a lower cost of production, higher brand reliability, better agility in responding to customer needs, and eliminating counterfeit distribution. This creates win-win situations across all involved stakeholders.
The value proposition of digital transformations has been proved through various lighthouse projects across the country, and we are at a pivotal stage to bring it across not only large companies but also mid-sized pharmaceutical companies within India to unlock its potential.
The writer is the executive vice-president (process manufacturing) & chief customer 0fficer at Bar Code India.
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